Healthy
Conditions
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.
Interventions
BIOLOGICALAd26.Filo
Ad26.Filo intramuscular (IM) injection at a dose of 9\*10\^10 viral particles (vp).
BIOLOGICALMVA-BN-Filo
MVA-BN-Filo intramuscular (IM) injection at a dose of 5\*10\^8 infectious units (Inf U).
BIOLOGICALAd26.ZEBOV
Ad26.ZEBOV intramuscular (IM) injection at a dose of 5\*10\^10 vp.
BIOLOGICALPlacebo
IM injection of 0.9 percent saline.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Binding Antibody Responses Against Ebola Virus (EBOV), Marburg Virus (MARV), and Sudan Virus (SUDV) Glycoproteins (GPs) | Up to Day 360 |
Countries
United States
Outcome results
None listed