To Assess the Safety, Immunogenicity and Efficacy of VLPM01 in Healthy, Malaria-Naïve Volunteers
Completed · Phase 1
Conditions studied: Malaria,Falciparum
In brief
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).
Key facts
- Study ID
- NCT03867331
- Run by
- VLP Therapeutics
- People needed
- 36
- Starts
- 2019-03-13
- Expected to finish
- 2020-05-21
- Last updated by the study team
- 2021-04-08
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.
Where it is running
- Walter Reed Army Institute of Research — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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