A Phase 1, First-in-human Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adult
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse events (AEs)
研究概览
简要总结
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Body mass index (BMI) of greater than or equal to (>=) 18.5 and less than (<) 35.0 kilogram per square meter (kg/m^2)
- •Healthy on the basis of physical examination, medical history, and the investigator's clinical judgment
- •All women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at screening, have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
- •A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction from the start of screening onwards until at least 3 months after the last vaccination
- •Participant must be available and willing to participate for the duration of the study visits and follow-up
排除标准
- •Has been vaccinated with a candidate filovirus vaccine
- •Has received any Ad26- or MVA-based candidate vaccines in the past
- •Has been diagnosed with disease caused by Ebola virus (EBOV), Marburg virus (MARV), Sudan virus (SUDV), or Taï Forest virus (TAFV) or exposed to EBOV, MARV, SUDV, or TAFV, including participants who traveled to epidemic filovirus areas in West Africa during the last 2 years (that is, since the start of the last Ebolavirus outbreak) should be excluded from the study
- •Chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
- •Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or body temperature greater than or equal to (>=) 38.0 degree Celsius on Day 1
研究组 & 干预措施
Group 2: MVA-BN-Filo/AD26.Filo or Placebo
Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57.
干预措施: MVA-BN-Filo (Biological)
Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo
Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
干预措施: Placebo (Biological)
Group 1: AD26.Filo/MVA-BN-Filo or Placebo
Participants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
干预措施: Placebo (Biological)
Group 2: MVA-BN-Filo/AD26.Filo or Placebo
Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57.
干预措施: Placebo (Biological)
Group 3: MVA-BN-Filo/AD26.Filo or Placebo
Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15.
干预措施: Placebo (Biological)
Subset of Group 3: AD26.Filo or Placebo
The first 8 participants in Group 3 who are willing to enroll in the subset for third vaccination, will receive a third vaccination at Day 92. Participants who previously received placebo will receive placebo a third time and participants who previously received MVA-BN-Filo/Ad26.Filo vaccination will receive Ad26.Filo as third vaccination. After enrollment of the 8 participants, the unblinded monitor and unblinded pharmacist will assess whether 7 participants who previously received MVA-BN-Filo/Ad26.Filo vaccination have been enrolled. If less than 7 participants of the active vaccine regimen have been enrolled, 2 additional participants will be enrolled. If at least 7 participants of the active vaccine regimen have been enrolled, no further will be enrolled. The aim is to enroll 7 or 8 participants who will receive Ad26.Filo as third vaccination.
干预措施: Placebo (Biological)
Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo
Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
干预措施: Ad26.ZEBOV (Biological)
Group 3: MVA-BN-Filo/AD26.Filo or Placebo
Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15.
干预措施: Ad26.Filo (Biological)
Group 2: MVA-BN-Filo/AD26.Filo or Placebo
Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57.
干预措施: Ad26.Filo (Biological)
Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo
Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
干预措施: MVA-BN-Filo (Biological)
Subset of Group 3: AD26.Filo or Placebo
The first 8 participants in Group 3 who are willing to enroll in the subset for third vaccination, will receive a third vaccination at Day 92. Participants who previously received placebo will receive placebo a third time and participants who previously received MVA-BN-Filo/Ad26.Filo vaccination will receive Ad26.Filo as third vaccination. After enrollment of the 8 participants, the unblinded monitor and unblinded pharmacist will assess whether 7 participants who previously received MVA-BN-Filo/Ad26.Filo vaccination have been enrolled. If less than 7 participants of the active vaccine regimen have been enrolled, 2 additional participants will be enrolled. If at least 7 participants of the active vaccine regimen have been enrolled, no further will be enrolled. The aim is to enroll 7 or 8 participants who will receive Ad26.Filo as third vaccination.
干预措施: Ad26.Filo (Biological)
Group 3: MVA-BN-Filo/AD26.Filo or Placebo
Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15.
干预措施: MVA-BN-Filo (Biological)
Group 1: AD26.Filo/MVA-BN-Filo or Placebo
Participants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
干预措施: MVA-BN-Filo (Biological)
Group 1: AD26.Filo/MVA-BN-Filo or Placebo
Participants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
干预措施: Ad26.Filo (Biological)
结局指标
主要结局
Number of Participants With Adverse events (AEs)
时间窗: Up to 28 days after the last vaccination
Number of Participants With Reactogenicity (ie, Solicited Local and Systemic Adverse Events)
时间窗: One Week after each study vaccine administration
Number of Participants With Serious Adverse Events
时间窗: Up to the end of long-term follow-up (Day 360)
次要结局
- Binding Antibody Responses Against Ebola Virus (EBOV), Marburg Virus (MARV), and Sudan Virus (SUDV) Glycoproteins (GPs)(Up to Day 360)