A 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 Adults
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: Ad26.FiloBiological: Ad26.ZEBOVBiological: MVA-BN-FiloBiological: Placebo
- Registration Number
- NCT02860650
- Lead Sponsor
- Janssen Vaccines & Prevention B.V.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: AD26.Filo/MVA-BN-Filo or Placebo Placebo Participants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57. Subset of Group 3: AD26.Filo or Placebo 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. Group 3: MVA-BN-Filo/AD26.Filo or Placebo Ad26.Filo Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15. Subset of Group 3: AD26.Filo or Placebo Ad26.Filo 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. Group 1: AD26.Filo/MVA-BN-Filo or Placebo Ad26.Filo Participants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57. Group 2: MVA-BN-Filo/AD26.Filo or Placebo Ad26.Filo Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57. Group 2: MVA-BN-Filo/AD26.Filo or Placebo MVA-BN-Filo Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57. Group 3: MVA-BN-Filo/AD26.Filo or Placebo MVA-BN-Filo Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15. Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo MVA-BN-Filo Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57. Group 1: AD26.Filo/MVA-BN-Filo or Placebo MVA-BN-Filo Participants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57. Group 3: MVA-BN-Filo/AD26.Filo or Placebo Placebo Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15. Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo Placebo Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57. Group 2: MVA-BN-Filo/AD26.Filo or Placebo Placebo Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57. Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo Ad26.ZEBOV Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse events (AEs) Up to 28 days after the last vaccination Number of Participants With Reactogenicity (ie, Solicited Local and Systemic Adverse Events) One Week after each study vaccine administration Number of Participants With Serious Adverse Events Up to the end of long-term follow-up (Day 360)
- Secondary Outcome Measures
Name Time Method Binding Antibody Responses Against Ebola Virus (EBOV), Marburg Virus (MARV), and Sudan Virus (SUDV) Glycoproteins (GPs) Up to Day 360