NCT04268420

A Trial For The Study of Falciparum Malaria Protein 013 Administered Via Intramuscular Injection in Healthy Adults

Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) for Safety, Protective Efficacy, and Immunogenicity of Plasmodium Falciparum Malaria Protein (FMP013) Administered Intramuscularly With ALFQ Healthy Malaria-Naïve Adults

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, open label clinical study to evaluate the safety, immunogenicity, tolerability and efficacy of Plasmodium falciparum Malaria Protein 013 (FMP013) combined with (ALF with QS-21), saponin molecule derived from the bark of Quillaja species (ALFQ)) in healthy adult volunteers at different doses and dosing schedules.

Detailed description

This is an open-label immunization with Controlled Human Malaria Infection (CHMI) study. Healthy, malaria-naïve adults, aged 18-55 years old will be recruited into one of 5 experimental cohorts in 2 parts. In Part A, 2 experimental cohorts of 5 subjects each will receive a series of 3 vaccinations at 0, 1, and 2 months at 2 doses (the "low dose" arm and the "high dose" arm). In Part B, 3 experimental cohorts of 10 subjects will receive a series of 3 vaccinations at 0, 1, 6 months (called the "delayed dose" arm), the "delayed fractional dose" arm is vaccinated at 0, 1, and 6 months with the 6 month dose being 1/5 the other doses, and the "standard" arm" at the 4th, 5th, and 6th month (after the first 2 vaccinations of the other 2 arms in Part B).

Conditions

• Vaccine Reaction

Interventions

Type	Name	Description
DRUG	FMP013	Falciparum Malaria Protein-13
DRUG	ALFQ	ALF with QS-21, saponin molecule derived from the tree bark of Quillaja species

Timeline

• Start date: 2020-03-20
• Primary completion: 2023-07-01
• Completion: 2023-12-01
• First posted: 2020-02-13
• Last updated: 2023-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study