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NCT03583606 · ClinicalTrials.gov registry record · Phase 1
A Trial to Evaluate the Safety and Systems Biology Response of Ebolavirus Zaire Vaccine (ChAd3-EBO-Z)
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT03583606: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03583606 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03583606, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
This initial, proof of concept study will focus on identifying significant differences in response to the Ebolavirus Zaire vaccine (ChAd3-EBO-Z) when administered with placebo, MVA-BN(R)-Filo, or ChAd3-EBO-Z boosters after 8 days. All 60 participants will receive the ChAd3-EBO-Z vaccine and then randomized into each booster group (20 receiving each type of booster). Subjects will be followed-up for 6 months to monitor for safety outcomes and efficacy measures. There is no formal hypothesis for this study. The primary objective of this study is to assess the safety and reactogenicity of study products by study group when administered IM to healthy adults.
Primary Outcome
Laboratory parameters include white blood cells (WBC), hemoglobin, platelet count, absolute neutrophil count, alanine aminotransferase (ALT), creatinine, sodium, potassium and blood urea nitrogen (BUN). Thresholds for adverse events were considered as WBC \<= 4.4 K/mcL or \>=13.1 K/mcL (18 to \<21 years) or \<= 4.4 K/mcL or \>= 11.1 K/mcL (\>=21 years), hemoglobin \<= 11.6 g/dL (female) or \<= 13.2 g/dL (male), platelet count \<= 134 K/mcL or \>= 467 K/mcL, absolute neutrophil count \<1.8 K/mcL
Interventions
- OTHER Placebo
- BIOLOGICAL ChAd3-EBO-Z
- BIOLOGICAL MVA Multi-Filo Ebola Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2018-11-12 |
| Est. Completion | 2020-01-14 |
| Phase | Phase 1 |
What the finished NCT03583606 record still lists
NCT03583606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03583606 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03583606 about?
NCT03583606 is a clinical study titled "A Trial to Evaluate the Safety and Systems Biology Response of Ebolavirus Zaire Vaccine (ChAd3-EBO-Z)". This initial, proof of concept study will focus on identifying significant differences in response to the Ebolavirus Zaire vaccine (ChAd3-EBO-Z) when administered with placebo, MVA-BN(R)-Filo, or ChAd3-EBO-Z boosters after 8 days. All 60 participants will receive the ChAd3-EBO-Z vaccine and then ran...
What is the current status of trial NCT03583606?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2018-11-12. Estimated completion is 2020-01-14.
What interventions are being tested in trial NCT03583606?
The interventions under investigation include: Placebo (OTHER), ChAd3-EBO-Z (BIOLOGICAL), MVA Multi-Filo Ebola Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03583606?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03583606's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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