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NCT03867331 · ClinicalTrials.gov registry record · Phase 1
To Assess the Safety, Immunogenicity and Efficacy of VLPM01 in Healthy, Malaria-Naïve Volunteers
A Phase 1 study, sponsored by VLP Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03867331: Completed Phase 1 study, sponsored by VLP Therapeutics.
NCT03867331 is a Phase 1 study that has completed, run by VLP Therapeutics. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03867331, a Phase 1 study, has completed, sponsored by VLP Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This study is a proof-of-concept, first in human, Phase I, single center study designed to evaluate the safety, tolerability, immunogenicity and experimental efficacy of VLPM01 in healthy, malaria-naïve adult volunteers. The VLPM01 product will be adjuvanted with alhydrogel. The study design was based on the FDA's guidance "General Principles for the Development of Vaccines to protect Against Global Infectious Diseases" (2011).
Interventions
- BIOLOGICAL 5 microgram VLPM01
- BIOLOGICAL 15 microgram VLPM01
- BIOLOGICAL 30 microgram VLPM01
- OTHER Plasmodium falciparum challenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-03-13 |
| Est. Completion | 2020-05-21 |
| Phase | Phase 1 |
What the finished NCT03867331 record still lists
NCT03867331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 4 interventions - of which 5 microgram VLPM01 is the first listed.
NCT03867331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03867331 about?
NCT03867331 is a clinical study titled "To Assess the Safety, Immunogenicity and Efficacy of VLPM01 in Healthy, Malaria-Naïve Volunteers". This study is a proof-of-concept, first in human, Phase I, single center study designed to evaluate the safety, tolerability, immunogenicity and experimental efficacy of VLPM01 in healthy, malaria-naïve adult volunteers. The VLPM01 product will be adjuvanted with alhydrogel. The study design was bas...
What is the current status of trial NCT03867331?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2019-03-13. Estimated completion is 2020-05-21.
What interventions are being tested in trial NCT03867331?
The interventions under investigation include: 5 microgram VLPM01 (BIOLOGICAL), 15 microgram VLPM01 (BIOLOGICAL), 30 microgram VLPM01 (BIOLOGICAL), Plasmodium falciparum challenge (OTHER).
Who is sponsoring clinical trial NCT03867331?
This trial is sponsored by VLP Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03867331's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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