A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants

Completed · Phase 3 · Has a placebo group

Conditions studied: Ebola

In brief

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.

Key facts

Study ID: NCT04228783
Run by: Janssen Vaccines & Prevention B.V.
People needed: 974
Starts: 2020-02-18
Expected to finish: 2022-04-25
Last updated by the study team: 2025-05-25

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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 1. 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

Where it is running

Coastal Clinical Research, Inc — Mobile, Alabama, United States
Clinical Research Consortium, an AMR company — Tempe, Arizona, United States
Central Kentucky Research Associates, Inc. — Lexington, Kentucky, United States
The Center For Pharmaceutical Research — Kansas City, Missouri, United States
Clinical Research Consortium, an AMR company — Las Vegas, Nevada, United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company — Knoxville, Tennessee, United States
Alliance for Multispeciality Research — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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