A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, Reactogenicity, and Consistency of a Heterologous 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN®-Filo in Adult Participants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 974
- 试验地点
- 6
- 主要终点
- Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21 Days Post Vaccination 2
研究概览
简要总结
The purpose of this study is to demonstrate that the paired 2-dose vaccine regimens from 3 consecutively manufactured lots of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 and 3 consecutively manufactured lots of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) including the ebola virus mayinga glycoprotein as Dose 2, administered at a 56-day interval, induce an equivalent humoral immune response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed an informed consent form (ICF)
- •Medically stable in the investigator's clinical judgment on the basis of physical examination, medical history, and vital signs performed at screening
- •Before randomization, a woman must be either: a. Not of childbearing potential; b. Of childbearing potential and practicing an acceptable effective method of birth control and agrees to remain on such a method of birth control from signing the informed consent form (ICF) until at least 3 months post Dose 1 vaccination or 28 days post Dose 2 vaccination or 3 months post booster vaccination (Groups 5-6 only), whichever comes later. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. Acceptable effective methods for this study include: 1) hormonal contraception; 2) intrauterine device (IUD); 3) intrauterine hormone-releasing system (IUS); 4) male or female condom with or without spermicide; 5) cap, diaphragm, or sponge with a vaginal spermicide; 6) vasectomized partner (the vasectomized partner should be the sole partner for that participant); 7) sexual abstinence
- •Women of childbearing potential must have a negative urine Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and immediately prior to each study vaccine administration
- •Available and willing to participate for the duration of the study and follow-up visit
- •Willing to provide verifiable identification
排除标准
- •Having received any candidate Ebola vaccine
- •Diagnosed with Ebola virus disease (EVD), or prior exposure to Ebola virus, including travel to an area with Ebola outbreak less than 1 month prior to screening (if applicable)
- •Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines), including known allergy to egg, egg products, and aminoglycosides
- •Presence of acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0ºCelcius on Day
- •Participants with such symptoms will be excluded from enrollment at that time but may be rescheduled for enrollment at a later date
- •Human immunodeficiency virus (HIV) type 1 or type 2 infection, based on the medical history reported by the participant
- •Pregnant, breast-feeding
- •History of an underlying clinically significant acute or chronic medical condition
研究组 & 干预措施
Active Vaccine: Group 1 (Ad26.ZEBOV-Lot A, MVA-BN-Filo-Lot 1)
Participants will receive Intramuscular injection (0.5 milliliter [mL]) of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particle(s) [vp], Lot A) on Day 1, followed by Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious unit(s) [Inf U], Lot 1) on Day 57.
干预措施: Ad26.ZEBOV (Biological)
Active Vaccine: Group 1 (Ad26.ZEBOV-Lot A, MVA-BN-Filo-Lot 1)
Participants will receive Intramuscular injection (0.5 milliliter [mL]) of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particle(s) [vp], Lot A) on Day 1, followed by Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious unit(s) [Inf U], Lot 1) on Day 57.
干预措施: MVA-BN-Filo (Biological)
Active Vaccine: Group 2 (Ad26.ZEBOV-Lot B, MVA-BN-Filo-Lot 2)
Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
干预措施: Ad26.ZEBOV (Biological)
Active Vaccine: Group 2 (Ad26.ZEBOV-Lot B, MVA-BN-Filo-Lot 2)
Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
干预措施: MVA-BN-Filo (Biological)
Active Vaccine: Group 3 (Ad26.ZEBOV-Lot C, MVA-BN-Filo-Lot 3)
Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
干预措施: Ad26.ZEBOV (Biological)
Active Vaccine: Group 3 (Ad26.ZEBOV-Lot C, MVA-BN-Filo-Lot 3)
Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
干预措施: MVA-BN-Filo (Biological)
Control Vaccine: Group 4 (Placebo)
Participants will receive Intramuscular injection (0.5 mL) of placebo (0.9 percent [%] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
干预措施: Placebo (Biological)
Booster Cohort: Group 5 (Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV)
Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and a booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
干预措施: Ad26.ZEBOV (Biological)
Booster Cohort: Group 5 (Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV)
Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and a booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
干预措施: MVA-BN-Filo (Biological)
Booster Cohort: Group 6 (Placebo)
Participants will receive Intramuscular injection (0.5 mL) of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by placebo matching to MVA-BN-Filo as Dose 2 on Day 57 and a booster dose of matching placebo on Day 177.
干预措施: Placebo (Biological)
结局指标
主要结局
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21 Days Post Vaccination 2
时间窗: 21 Days Post Vaccination 2 (Day 78)
Antibody GMCs against the EBOV GP as measured by ELISA at 21 days post Vaccination 2 were reported. GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) of 36.11 EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.
次要结局
- Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2(Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64))
- Number of Participants With Unsolicited Adverse Events (AEs) Until 28 Days After Vaccination 1 and 2(Until 28 Days After Vaccination 1 on Day 1 (Up to Day 29); until 28 days after Vaccination 2 on Day 57 (Up to Day 85))
- Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2(Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64))
- Number of Participants With Serious Adverse Events (SAEs)(Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6)
- Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 56 Days Post Vaccination 1(56 Days Post Vaccination 1 (Day 57))