drugset / Trial / NCT03867331

To Assess the Safety, Immunogenicity and Efficacy of VLPM01 in Healthy, Malaria-Naïve Volunteers

NCT03867331 ↗

Phase 1 Completed 36 enrolled VLP Therapeutics
Non-randomizedSequentialOpen-labelPrevention

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).

Timeline

Start
2019-03-13
Primary completion
2020-05-21
Completion
2020-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject VLPM01 Vaccine 5 ug Intramuscular
Subject VLPM01 Vaccine 15 ug Intramuscular
Subject VLPM01 Vaccine 30 ug Intramuscular