A Phase 3 interventional study of Ad26.ZEBOV 5*10^10 viral particles (vp) and Ad26.ZEBOV 2*10^10 (vp) in Healthy, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 6 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Janssen Vaccines & Prevention B.V. (part of Johnson & Johnson) · Phase 3, Interventional, and Prevention
The purpose of this study is to demonstrate the non-inferiority of a heterologous prime-boost regimen using Ad26.ZEBOV as prime and MVA-BN-Filo as boost administered at different doses at a 56-day interval versus the same regimen with the recently released batches of Ad26.ZEBOV and MVA-BN-Filo in terms of humoral immune response against the Ebola virus (EBOV) GP (glycoprotein) as measured by enzyme-linked immunosorbent assay (ELISA) at 21 days post boost.
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate safety and immunogenicity of Ad26.ZEBOV and MVA-BN-Filo at different dose levels, administered to healthy adults participants. The study consists of a Screening period of up to 6 weeks, vaccinations on Day 1 and Day 57, and a post-vaccination phase until the 6 months post-boost visit (Day 237). The participants will be randomized at baseline (on Day 1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the study.
104 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.
This study's enrollment of 525 is above the median of 94 across 81 interventional studies indexed under Hemorrhagic Fever, Ebola.
Browse Hemorrhagic Fever, Ebola studies →Janssen Vaccines & Prevention B.V. is the lead sponsor of 49 studies on the registry; none are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 32 (86%) have results posted.
First submitted after Janssen Vaccines & Prevention B.V. became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ad26.ZEBOV 5\*10\^10 viral particles (vp) single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 1\*10\^8 Infectious Unit \[Inf. U.\] single dose IM injection on Day 57
Biological: Ad26.ZEBOV 5*10^10 viral particles (vp) · Biological: MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]
Ad26.ZEBOV 2\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U single dose IM injection on Day 57
Biological: Ad26.ZEBOV 2*10^10 (vp) · Biological: MVA-BN-Filo 5*10^7 Inf. U.
Ad26.ZEBOV 0.8\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U. single dose IM injection on Day 57
Biological: Ad26.ZEBOV 0.8*10^10 (vp) · Biological: MVA-BN-Filo 5*10^7 Inf. U.
Participants will receive intramuscular (IM) injection of Placebo (0.9% saline) once on Day 1 and Day 57
Biological: Placebo
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 2\*10\^10 viral particles on Day 1
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 0.8\*10\^10 viral particles on Day 1
MVA-BN-Filo- live replication incompetent vaccine, IM injection of 1\*10\^8 Infectious Unit \[Inf. U.\] once on Day 57
MVA-BN-Filo- live replication incompetent vaccine, IM injection of 5\*10\^7 Inf. U. once on Day 57
One 0.5 ml IM injection of 0.9% saline administered once on Day 1 and Day 57
Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
Time frame: At 21 days post boost vaccination
Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
Time frame: At Days 1, 29, 57 post prime dose and at days 42, and 180 post boost vaccination
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
Time frame: Up to 7 days after each vaccination
Number of Participants with Adverse Events (AEs)
Time frame: Up to 42 days post boost vaccination
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Continuous throughout the duration of study (Up to Day 237)
Ran from Sep 2015 to primary completion in Jun 2016, 8 months.
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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