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临床试验/NCT02743455
NCT02743455
已完成
1 期

A Phase I, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of MVA-BN Yellow Fever Vaccine With and Without Montanide ISA 720 Adjuvant in 18-45 Year Old Healthy Adults

National Institute of Allergy and Infectious Diseases (NIAID)2 个研究点 分布在 1 个国家目标入组 92 人2016年7月5日

概览

阶段
1 期
干预措施
ISA-720
疾病 / 适应症
Yellow Fever
发起方
National Institute of Allergy and Infectious Diseases (NIAID)
入组人数
92
试验地点
2
主要终点
Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 3
状态
已完成
最后更新
2个月前

概览

简要总结

This study is a multi-center, double-blind, placebo-controlled, Phase I study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) in Flavivirus-naive healthy male and non-pregnant female adult subjects. There are six dose groups in this study. Subjects who have never received a licensed or investigational smallpox vaccine will be randomized to Groups 1-5 and vaccine administration and follow-up will be conducted in a double-blinded fashion. Subjects who have previously received two, 1 x 10^8 TCID50 doses of Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) between 19 and 45 days apart by s ubcutaneous (SC) or intramuscular (IM) routes will be enrolled in Group 6 and will be dosed open-label. Since this is a first in human, phase I study, a sentinel cohort will be utilized. The first two subjects (1st sentinel group) one at each clinical site will be randomized to Group 2 or 3 and vaccinated with MVA-BN-YF with or without Montanide ISA 720 adjuvant (ISA 720). Subjects and study personnel will be blinded as to whether ISA 720 was administered. The primary objectives are the: 1) assessment of the safety, tolerability, and reactogenicity of MVA-BN-YF vaccine administered with or without ISA 720; 2) comparison of the safety, tolerability, and reactogenicity of MVA-BN-YF vaccine administered with or without ISA 720 with Yellow Fever Vaccine (YF-VAX) and MVA-BN.

详细描述

This study is a multi-center, double-blind, placebo-controlled, Phase I study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) in Flavivirus-naive healthy male and non-pregnant female adult subjects. There are six dose groups in this study. Subjects who have never received a licensed or investigational smallpox vaccine will be randomized to Groups 1-5 and vaccine administration and follow-up will be conducted in a double-blinded fashion. Subjects who have previously received two, 1 x 10\^8 TCID50 doses of Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) between 19 and 45 days apart by subcutaneous (SC) or intramuscular (IM) routes will be enrolled in Group 6 and will be dosed open-label. Since this is a first in human, phase I study, a sentinel cohort will be utilized. The first two subjects (1st sentinel group) one at each clinical site will be randomized to Group 2 or 3 and vaccinated with MVA-BN-YF with or without Montanide ISA 720 adjuvant (ISA 720). Subjects and study personnel will be blinded as to whether ISA 720 was administered. Subjects will be monitored for safety for one day, and if no pre-defined halting rule is met then two additional subjects (2nd sentinel group) one at each clinical site will be assigned to the group the previous subject was not assigned to. These subjects will be vaccinated and monitored as above. A total of 4 sentinel subjects will be vaccinated. The primary objectives are the: 1) assessment of the safety, tolerability, and reactogenicity of MVA-BN-YF vaccine administered with or without ISA 720; 2) comparison of the safety, tolerability, and reactogenicity of MVA-BN-YF vaccine administered with or without ISA 720 with Yellow Fever Vaccine (YF-VAX) and MVA-BN. The secondary objectives are the: 1) assessment of the immunogenicity against the MVA-BN backbone and Yellow Fever Virus (YF) antigen insert of MVA-BN-YF with and without ISA 720 as assessed by kinetics of the immune responses, seroconversion rates, and peak Geometric Mean Titer (GMT); 2) assessment of the impact of previous MVA-BN vaccination on peak immune responses to YF antigen in MVA-BN-YF; 3) comparison of the peak immunogenicity against YF antigen of 1 or 2 doses of MVA-BN-YF with or without ISA 720 with YF-VAX; 4) comparison of the peak immunogenicity against the MVA-BN backbone of 1 or 2 doses of MVA-BN-YF with or without ISA 720 with MVA-BN; 5) assessment of durability of immune response to YF antigen and MVA-BN at 6 months after 2nd vaccination or placebo administration.

注册库
clinicaltrials.gov
开始日期
2016年7月5日
结束日期
2018年3月22日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

入选标准

  • Must be a male or female at least 18 to \< / = 45 years old at the time of screening.
  • Must be able to read and provide written consent and complete the Informed Consent.
  • Must have a body mass index (BMI) \> / = 18.5 and \< 35.0 kg/m\^
  • Must be in good health on the basis of physical examination, vital signs\*, medical history, safety laboratories, and the investigator's clinical judgment. \*Safety laboratory normal ranges will be those used by the reference clinical lab. Protocol-specific criteria for individual subjects are listed in criteria #6
  • The clinical laboratory evaluations that will be graded as laboratory Adverse Events (AEs) and be considered for the Study or Individual Halting Rules are those which are included in the laboratory toxicity grading scales.
  • Vital signs must be in normal ranges. If a subject has elevated systolic or diastolic blood pressure, subject may rest for 10 minutes in a quiet room and then the blood pressure may be retaken once.
  • For Group 6: subjects must have documented previous vaccination with MVA-BN\*. \*In order to be enrolled, a subject has to have received two 1x10\^8 TCID50 doses of MVA-BN 19-45 days apart subcutaneous (SC) or intramuscular (IM) as part of participation in DMID vaccine trials 11-0021 or 09-
  • First dose must have been administered no earlier than
  • Must have acceptable\* laboratory criteria within 28 days before enrollment.
  • \*Acceptable lab parameters include:

排除标准

  • Was ever vaccinated with a licensed or investigational YF vaccine or was diagnosed with YF infection or disease\*.
  • \*Includes YF-VAX, Stamaril, or Bio-Manguinhos yellow fever vaccine. Subject's verbal history will suffice.
  • Was ever vaccinated with a licensed or investigational Flavivirus vaccine\*.
  • \*Including Japanese encephalitis virus (JEV) vaccine or an investigational Flavivirus vaccine including dengue virus (DENV) or West Nile virus vaccine, or has been diagnosed with an illness caused by a Flavivirus including DENV, West Nile virus (WNV), JEV, St. Louis encephalitis, or tick-borne encephalitis virus (TBEV). Subject's verbal history will suffice.
  • Positive serology for HIV, Hepatitis C virus, or Hepatitis B surface antigen.
  • Positive serology to Dengue, Yellow Fever, or West Nile virus.
  • Plans to travel to a Yellow-Fever endemic area during the course of the study\* or travel to a Yellow-Fever endemic area within 30 days of screening.
  • \*Subjects who have a recent travel to a Yellow Fever endemic area may screen if they have returned to the U.S. 30 or more days prior to the screening visit. Refer to the CDC Yellow Fever map for countries/regions at risk for Yellow Fever virus infection. http://www.cdc.gov/yellowfever/maps/
  • Was ever vaccinated with a licensed or investigational smallpox vaccine\* with the exception of subjects in Group
  • \*Includes Dryvax, Acam2000, LC 16 m8, MVA-based vaccine candidate or licensed vaccines, and Imvamune or Imvanex.

研究组 & 干预措施

Group 3

Subjects will receive 1.0x10\^8 TCID50 of MVA-BN-YF + ISA 720 as two doses intramuscularly on Day 1 and Day 29. N=15

干预措施: ISA-720

Group 3

Subjects will receive 1.0x10\^8 TCID50 of MVA-BN-YF + ISA 720 as two doses intramuscularly on Day 1 and Day 29. N=15

干预措施: MVA-BN Yellow Fever Vaccine

Group 4

Subjects will receive 1.0x10\^8 TCID50 of MVA-BN-YF + ISA 720 as a single dose intramuscularly on Day 1 and matching placebo on Day 29. N=15

干预措施: ISA-720

Group 4

Subjects will receive 1.0x10\^8 TCID50 of MVA-BN-YF + ISA 720 as a single dose intramuscularly on Day 1 and matching placebo on Day 29. N=15

干预措施: MVA-BN Yellow Fever Vaccine

Group 1

Subjects will receive 1.0x10\^8 TCID50 of MVA-BN as two doses subcutaneously on Day 1 and Day 29. N=15

干预措施: MVA Smallpox Vaccine

Group 2

Subjects will receive 1.0x10\^8 TCID50 of MVA-BN-YF as two doses intramuscularly on Day 1 and Day 29. N=15

干预措施: MVA-BN Yellow Fever Vaccine

Group 4

Subjects will receive 1.0x10\^8 TCID50 of MVA-BN-YF + ISA 720 as a single dose intramuscularly on Day 1 and matching placebo on Day 29. N=15

干预措施: Placebo

Group 5

Subjects will receive = / \> 4.74 log10 PFU of YF-Vax as a single dose subcutaneously on Day 1 and matching placebo on Day 29. N=15

干预措施: Placebo

Group 5

Subjects will receive = / \> 4.74 log10 PFU of YF-Vax as a single dose subcutaneously on Day 1 and matching placebo on Day 29. N=15

干预措施: YF Vax 17D Strain

Group 6

Subjects with prior receipt of MVA-BN will receive 1.0x10\^8 TCID50 of MVA-BN-YF as two doses intramuscularly on Day 1 and Day 29. N=15

干预措施: MVA-BN Yellow Fever Vaccine

结局指标

主要结局

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 3

时间窗: Day 1 through Day 394

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 1

时间窗: Day 1 through Day 394

Number of serious adverse events (SAEs) considered related to study vaccination in Group 1

时间窗: Day 1 through Day 394

Number of serious adverse events (SAEs) considered related to study vaccination in Group 2

时间窗: Day 1 through Day 394

Number of serious adverse events (SAEs) considered related to study vaccination in Group 4

时间窗: Day 1 through Day 394

Number of serious adverse events (SAEs) considered related to study vaccination in Group 6

时间窗: Day 1 through Day 394

Occurrence of solicited systemic reactogenicity events in Group 5

时间窗: Day 29 through Day 36

Comparison of Grade 3 local, systemic or laboratory toxicities, continuous Grade 2 or greater local reactogenicity

时间窗: Day 29 through Day 36

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 2

时间窗: Day 1 through Day 394

Number of related serious adverse events (SAEs)

时间窗: Day 1 through Day 394

Number of serious adverse events (SAEs) considered related to study vaccination in Group 5

时间窗: Day 1 through Day 394

Number of subjects with unsolicited vaccine-related adverse events (AEs) in Group 5

时间窗: Day 1 through Day 57

Number of withdrawals or discontinuation of vaccinations due to any reason

时间窗: Day 1 through Day 394

Occurrence of solicited injection site reactogenicity events in Group 1

时间窗: Day 29 through Day 36

Occurrence of solicited systemic reactogenicity events in Group 1

时间窗: Day 29 through Day 36

Occurrence of solicited systemic reactogenicity events in Group 2

时间窗: Day 29 through Day 36

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 4

时间窗: Day 1 through Day 394

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 5

时间窗: Day 1 through Day 394

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 6

时间窗: Day 1 through Day 394

Number of serious adverse events (SAEs) considered related to study vaccination in Group 3

时间窗: Day 1 through Day 394

Number of adverse events of special interest (AESIs) considered related to study vaccination overall

时间窗: Day 1 through Day 394

Number of related adverse events of special interest (AESIs)

时间窗: Day 1 through Day 394

Occurrence of solicited injection site reactogenicity events in Group 5

时间窗: Day 29 through Day 36

Number of subjects with new onset of a chronic medical condition in Group 4

时间窗: Day 1 through Day 394

Number of subjects with new onset of a chronic medical condition in Group 5

时间窗: Day 1 through Day 394

Number of subjects with unsolicited vaccine-related adverse events (AEs) in Group 6

时间窗: Day 1 through Day 57

Number of serious adverse events (SAEs) considered related to study vaccination overall

时间窗: Day 1 through Day 394

Number of subjects with new onset of a chronic medical condition in Group 1

时间窗: Day 1 through Day 394

Number of subjects with new onset of a chronic medical condition in Group 2

时间窗: Day 1 through Day 394

Number of subjects with new onset of a chronic medical condition in Group 3

时间窗: Day 1 through Day 394

Number of vaccine-related laboratory adverse events (AEs) in Group 6

时间窗: Day 1 through Day 57

Number of subjects with new onset of a chronic medical condition in Group 6

时间窗: Day 1 through Day 394

Number of subjects with new onset of a chronic medical condition overall

时间窗: Day 1 through Day 394

Number of subjects with unsolicited vaccine-related adverse events (AEs) in Group 1

时间窗: Day 1 through Day 57

Number of subjects with unsolicited vaccine-related adverse events (AEs) in Group 2

时间窗: Day 1 through Day 57

Number of subjects with unsolicited vaccine-related adverse events (AEs) in Group 3

时间窗: Day 1 through Day 57

Number of subjects with unsolicited vaccine-related adverse events (AEs) in Group 4

时间窗: Day 1 through Day 57

Number of vaccine-related laboratory adverse events (AEs) in Group 2

时间窗: Day 1 through Day 57

Number of vaccine-related laboratory adverse events (AEs) in Group 4

时间窗: Day 1 through Day 57

Number of vaccine-related laboratory adverse events (AEs) in Group 5

时间窗: Day 1 through Day 57

Occurrence of solicited systemic reactogenicity events in Group 4

时间窗: Day 29 through Day 36

Occurrence of solicited systemic reactogenicity events in Group 6

时间窗: Day 29 through Day 36

Number of subjects with unsolicited vaccine-related adverse events (AEs) overall

时间窗: Day 1 through Day 57

Number of vaccine-related laboratory adverse events (AEs) in Group 3

时间窗: Day 1 through Day 57

Number of vaccine-related laboratory adverse events (AEs) in Group 1

时间窗: Day 1 through Day 57

Occurrence of solicited injection site reactogenicity events in Group 3

时间窗: Day 29 through Day 36

Occurrence of solicited injection site reactogenicity events in Group 6

时间窗: Day 29 through Day 36

Occurrence of solicited injection site reactogenicity events overall

时间窗: Day 29 through Day 36

Occurrence of solicited systemic reactogenicity events in Group 3

时间窗: Day 29 through Day 36

Occurrence of solicited injection site reactogenicity events in Group 2

时间窗: Day 29 through Day 36

Occurrence of solicited injection site reactogenicity events in Group 4

时间窗: Day 29 through Day 36

Occurrence of solicited systemic reactogenicity events overall

时间窗: Day 29 through Day 36

Comparison of Grade 3 local, systemic or laboratory toxicities, continuous Grade 2 or greater local reactogenicity

时间窗: Day 1 through Day 8

Occurrence of solicited injection site reactogenicity events in Group 1

时间窗: Day 1 through Day 8

Occurrence of solicited injection site reactogenicity events in Group 2

时间窗: Day 1 through Day 8

Occurrence of solicited injection site reactogenicity events in Group 3

时间窗: Day 1 through Day 8

Occurrence of solicited injection site reactogenicity events in Group 4

时间窗: Day 1 through Day 8

Occurrence of solicited injection site reactogenicity events in Group 5

时间窗: Day 1 through Day 8

Occurrence of solicited injection site reactogenicity events in Group 6

时间窗: Day 1 through Day 8

Occurrence of solicited injection site reactogenicity events overall

时间窗: Day 1 through Day 8

Occurrence of solicited systemic reactogenicity events in Group 1

时间窗: Day 1 through Day 8

Occurrence of solicited systemic reactogenicity events in Group 2

时间窗: Day 1 through Day 8

Occurrence of solicited systemic reactogenicity events in Group 3

时间窗: Day 1 through Day 8

Occurrence of solicited systemic reactogenicity events in Group 4

时间窗: Day 1 through Day 8

Occurrence of solicited systemic reactogenicity events in Group 5

时间窗: Day 1 through Day 8

Occurrence of solicited systemic reactogenicity events in Group 6

时间窗: Day 1 through Day 8

Occurrence of solicited systemic reactogenicity events overall

时间窗: Day 1 through Day 8

次要结局

  • Comparison of geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 1 and Group 3(Day 211)
  • Comparison of geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 1 and Group 4(Day 211)
  • Comparison of geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 1 and Group 2(Day 211)
  • Comparison of geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 1 and Group 3(Day 211)
  • Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 5 and Group 6(Day 211)
  • Comparison of geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 1 and Group 4(Day 211)
  • Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 5 and Group 2(Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 1 and Group 4(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 2 and Group 3(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 3 and Group 4(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 2 and Group 4(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 3 and Group 6(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 4 and Group 6(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 5 and Group 6(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination with MVA-BN-YF in Group 6 compared to Group 2(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 2 and Group 3(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 4 and Group 5(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6(Day 1 through Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2(Day 57)
  • Comparison of geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 1 and Group 2(Day 211)
  • Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 5 and Group 3(Day 211)
  • Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 5 and Group 4(Day 211)
  • Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 6 and Group 2(Day 211)
  • Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 6 and Group 3(Day 211)
  • Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 6 and Group 4(Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 1 and Group 2(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 1 and Group 3(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 2 and Group 4(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 1 and Group 3(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 1 and Group 4(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 3 and Group 4(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 4(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination with MVA-BN-YF in Group 6 compared to Group 3(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 6(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 3 and Group 5(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 2 and Group 6(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 3 and Group 6(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 1 and Group 2(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 2 and Group 3(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 3(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 5(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 3 and Group 4(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 4 and Group 5(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination with MVA-BN-YF in Group 6 compared to Group 4(Day 36 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 2 and Group 4(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 2 and Group 5(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 3 and Group 4(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 3 and Group 5(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 4 and Group 6(Day 1 through Day 211)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 5 and Group 6(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3(Day 1 through Day 211)
  • Peak geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5(Day 1 through Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1(Day 57)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3(Day 57)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6(Day 57)
  • Peak geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4(Day 1 through Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4(Day 57)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2(Day 57)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2(Day 57)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3(Day 57)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1(Day 57)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3(Day 57)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4(Day 57)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6(Day 57)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4(Day 57)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5(Day 57)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6(Day 57)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1(Day 57)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2(Day 57)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3(Day 57)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4(Day 57)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2(Day 57)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3(Day 57)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4(Day 57)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5(Day 57)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6(Day 57)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 3(Day 15 through Day 22)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 4(Day 15 through Day 22)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 5(Day 15 through Day 22)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 6(Day 15 through Day 22)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 3 and Group 4(Day 15 through Day 22)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 3 and Group 5(Day 15 through Day 22)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 3 and Group 6(Day 15 through Day 22)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 4 and Group 5(Day 15 through Day 22)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 4 and Group 6(Day 15 through Day 22)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 5 and Group 6(Day 15 through Day 22)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination with MVA-BN-YF in Group 6 compared to Group 2(Day 15 through Day 22)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination with MVA-BN-YF in Group 6 compared to Group 3(Day 15 through Day 22)
  • Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination with MVA-BN-YF in Group 6 compared to Group 4(Day 15 through Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5(Day 50)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6(Day 15)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6(Day 211)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6(Day 22)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6(Day 36)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6(Day 43)
  • Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6(Day 50)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1(Day 1)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1(Day 15)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1(Day 211)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1(Day 22)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1(Day 29)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1(Day 36)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1(Day 43)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1(Day 50)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2(Day 1)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2(Day 15)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2(Day 211)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2(Day 22)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2(Day 29)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2(Day 36)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2(Day 43)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2(Day 50)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3(Day 1)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3(Day 15)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3(Day 211)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3(Day 22)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3(Day 29)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3(Day 36)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3(Day 43)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3(Day 50)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4(Day 1)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4(Day 15)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4(Day 211)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4(Day 22)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4(Day 29)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4(Day 36)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4(Day 43)
  • Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4(Day 50)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2(Day 1)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2(Day 15)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2(Day 211)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2(Day 22)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2(Day 29)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2(Day 36)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2(Day 43)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2(Day 50)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3(Day 1)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3(Day 15)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3(Day 211)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3(Day 22)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3(Day 29)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3(Day 36)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3(Day 43)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3(Day 50)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4(Day 1)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4(Day 15)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4(Day 211)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4(Day 22)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4(Day 29)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4(Day 36)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4(Day 43)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4(Day 50)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5(Day 1)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5(Day 15)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5(Day 211)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5(Day 22)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5(Day 29)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5(Day 36)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5(Day 43)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5(Day 50)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6(Day 1)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6(Day 15)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6(Day 211)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6(Day 22)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6(Day 29)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6(Day 36)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6(Day 43)
  • Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6(Day 50)

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