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

Malaria,Falciparum Clinical Trial

Official title:
A Phase I Dose Escalation Study With Controlled Human Malaria Infection (CHMI) to Assess the Safety, Immunogenicity and Efficacy of VLPM01 in Healthy, Malaria-Naïve Volunteers

Clinical Trial 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).

Clinical Trial Description

The study will have four (4) phases: Screening, Dose Escalation, Controlled Human Malaria Infection (CHMI) and Follow-Up. The study will be conducted at the Walter Reed Army Institute of Research in Silver Spring, Maryland (WRAIR), as this institute has extensive experience in conducting clinical studies of malaria vaccines with CHMI. A total of 36 participants will be enrolled in this study. Thirty (30) eligible participants will participate in the Dose Escalation Phase as vaccinees and 6 eligible participants will be added during the CHMI Phase to act as infectivity controls. Up to 6 additional eligible participants will serve as alternate vaccinees during the Dose Escalation Phase and up to 6 eligible participants will as act as alternate infectivity controls during the CHMI Phase. Alternates are only enrolled if a designated vaccinee is not eligible on the day of first vaccination or if a designated infectivity control is not eligible on the Day of Challenge. Withdrawn participants will not be replaced. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03867331
Study type Interventional
Source VLP Therapeutics
Contact
Status Completed
Phase Phase 1
Start date March 13, 2019
Completion date May 21, 2020
View Details
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