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
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02860650
- Run by
- Janssen Vaccines & Prevention B.V.
- People needed
- 72
- Starts
- 2016-08-01
- Expected to finish
- 2018-01-01
- Last updated by the study team
- 2018-02-05
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Rockville, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.