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NCT03547245 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted
A Phase 1 study, sponsored by International AIDS Vaccine Initiative.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT03547245: Completed Phase 1 study, sponsored by International AIDS Vaccine Initiative.
NCT03547245 is a Phase 1 study that has completed, run by International AIDS Vaccine Initiative. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03547245, a Phase 1 study, has completed, sponsored by International AIDS Vaccine Initiative.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
This is a phase 1 first-in-human clinical trial to assess the safety, tolerability, and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted, in up to 48 healthy adult HIV-negative volunteers.
Primary Outcome
To evaluate the safety and tolerability of the study regimens based on the frequency of local and systemic reactogenicity events as assessed using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v2.1).
Interventions
- BIOLOGICAL eOD-GT8 60mer + AS01B/ DPBS sucrose/IM
- BIOLOGICAL DPBS Sucrose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2021-08-13 |
| Phase | Phase 1 |
What the finished NCT03547245 record still lists
NCT03547245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which eOD-GT8 60mer + AS01B/ DPBS sucrose/IM is the first listed.
NCT03547245 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03547245 about?
NCT03547245 is a clinical study titled "A Phase I Trial to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted". This is a phase 1 first-in-human clinical trial to assess the safety, tolerability, and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted, in up to 48 healthy adult HIV-negative volunteers.
What is the current status of trial NCT03547245?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2018-06-15. Estimated completion is 2021-08-13.
What interventions are being tested in trial NCT03547245?
The interventions under investigation include: eOD-GT8 60mer + AS01B/ DPBS sucrose/IM (BIOLOGICAL), DPBS Sucrose (BIOLOGICAL).
Who is sponsoring clinical trial NCT03547245?
This trial is sponsored by International AIDS Vaccine Initiative, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03547245's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 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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