Safety, Tolerability, and Immunogenicity Dose-ranging Study of the Investigational Yellow Fever Vacine (vYF) Candidate Vaccine in Adults
Overview
- Phase
- Phase 1
- Intervention
- Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine
- Conditions
- Yellow Fever (Healthy Volunteers)
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Number of participants with serious adverse events
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
The primary objectives of the study are:
- To describe the safety profile of each of the 3 dosages of vYF and of YF-VAX® within the 28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit
- To describe the antibody responses elicited by each of the 3 dosages of vYF and by YF-VAX on Day 0 pre-vaccination and then on Day 10, Day 14, Day 28 and 6 months (Day 180) post-vaccination overall and by baseline flavivirus serostatus
- To quantify the detectable yellow fever (YF) vaccinal viremia in each vaccine groups (vYF and YF-VAX) in a subset of subjects on Day 0 visit, Day 1 visit, Day 3 visit, Day 5 visit, Day 7 visit, Day 10 visit, and Day 14 visit.
Detailed Description
Study duration per participant is approximately 6 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1
1 injection of vYF vaccine Dosage 1
Intervention: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine
Group 2
1 injection of vYF vaccine Dosage 2
Intervention: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine
Group 3
1 injection of vYF vaccine Dosage 3
Intervention: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine
Group 4
1 injection of YF-VAX
Intervention: Yellow fever vaccine
Outcomes
Primary Outcomes
Number of participants with serious adverse events
Time Frame: From Day 0 to Day 180
Serious adverse events are collected throughout the study
Number of participants with immediate adverse events
Time Frame: Within 30 minutes after vaccination
Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Number of participants with hematology and biochemistry out-of-range test results
Time Frame: From Day 0 to Day 14
Hematology and biochemistry values that are out-of-range are assessed
Number of participants with Grade 3 fever
Time Frame: Within 28 days after vaccination
Grade 3 fever is defined as temperature ≥ 102.1°F
Number of participants with solicited systemic reactions
Time Frame: Within 14 days after vaccination
Solicited systemic reactions include fever, headache, malaise, and myalgia
Number of participants with seroconversion to YF virus
Time Frame: From Day 0 to Day 28
Seroconversion is defined as a fourfold increase in neutralizing antibody titers as compared to pre-vaccination value. Seroconversion is assessed from Day 0 (pre-vaccination) to Day 10, Day 14 and Day 28.
Number of participants with neutralizing antibody titers against YF virus above pre-defined threshold
Time Frame: From Day 0 to Day 180
Pre-defined threshold of 10 1/dilution
Number of participants with YF vaccinal viremia
Time Frame: From Day 0 to Day 14
Vaccinal viremia is measured by YF specific quantitative reverse transcription polymerase chain reaction (RT-PCR) assay in samples collected on Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, and Day 14.
Number of participants with unsolicited adverse events
Time Frame: Within 28 days after vaccination
Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited adverse reactions
Number of participants with YF and flavivirus viremia and out-of-normal-range biological test results in the event of severe fever, or suspicion of neurotropic disease or acute viscerotropic diseases
Time Frame: Within 28 days after vaccination
Investigators are provided with guidelines for recognition and assessment of potential viscerotropic and neurotropic events
Number of participants with solicited injection site reactions
Time Frame: Within 7 days after vaccination
Solicited injection site reactions include injection site pain, erythema and swelling
Geometric mean titers of neutralizing antibodies against YF virus
Time Frame: From Day 0 to Day 180
Geometric mean titer ratio Day 10/Day 0, Day 14/Day 0, Day 28/Day 0 and Day 180/Day 0
Level of YF vaccinal viremia
Time Frame: From Day 0 to Day 14
Vaccinal viremia is measured by YF specific quantitative RT-PCR assay in samples collected on Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, and Day 14.