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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 is a Phase 1 study that has completed, run by VLP Therapeutics. The registered enrollment target is 36 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03867331
The ClinicalTrials.gov registry entry for NCT03867331 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VLP Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which 5 microgram VLPM01 is the first listed.
NCT03867331 reports 0 study locations.
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.
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