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NCT04228783 · ClinicalTrials.gov registry record · Phase 3
A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants
A Phase 3 study of Ebola, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 974
- Enrollment target
- 7
- Study locations
NCT04228783: Completed Phase 3 study of Ebola, sponsored by Janssen Vaccines & Prevention B.V..
NCT04228783 is a Phase 3 study of Ebola that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 974 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% higher). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04228783, a Phase 3 study of Ebola, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 974 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Primary Outcome
Antibody GMCs against the EBOV GP as measured by ELISA at 21 days post Vaccination 2 were reported. GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) of 36.11 EU/mL were imputed with half of
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Ad26.ZEBOV
- BIOLOGICAL MVA-BN-Filo
Study Locations (7)
Alabama
- Coastal Clinical Research, Inc - Mobile
Arizona
- Clinical Research Consortium, an AMR company - Tempe
Kentucky
- Central Kentucky Research Associates, Inc. - Lexington
Missouri
- The Center For Pharmaceutical Research - Kansas City
Nevada
- Clinical Research Consortium, an AMR company - Las Vegas
Tennessee
- AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company - Knoxville
Virginia
- Alliance for Multispeciality Research - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 974 participants |
| Start Date | 2020-02-18 |
| Est. Completion | 2022-04-25 |
| Phase | Phase 3 |
What the finished NCT04228783 record still lists
NCT04228783 is an interventional study that assigns participants to a tested intervention. The registered 974 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% higher).
The record links to 1 condition, with Ebola appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04228783 lists 7 locations in 7 states (Alabama, Arizona, Kentucky).
Frequently Asked Questions
What is clinical trial NCT04228783 about?
NCT04228783 is a clinical study titled "A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants". 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 ...
What is the current status of trial NCT04228783?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 974 participants. The study started on 2020-02-18. Estimated completion is 2022-04-25.
What conditions does trial NCT04228783 study?
This clinical trial studies the following conditions: Ebola.
What interventions are being tested in trial NCT04228783?
The interventions under investigation include: Placebo (BIOLOGICAL), Ad26.ZEBOV (BIOLOGICAL), MVA-BN-Filo (BIOLOGICAL).
Who is sponsoring clinical trial NCT04228783?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04228783 being conducted?
This trial has 7 study locations across Alabama, Arizona, Kentucky, Missouri, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04228783's enrollment target sits among peer trials
974 328th of 2000 higher than 1,672 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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