Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) Open-label Dose Safety, Reactogenicity, Immunogenicity, and Efficacy of the Vaccine Candidate Plasmodium Falciparum Malaria Protein (FMP012), Administered Intramuscularly With AS01B Adjuvant System in Healthy Malaria-Naïve Adults

NCT02174978 Phase 1 COMPLETED

The proposed study is a Phase 1 study with controlled human malaria infection (CHMI) designed primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system. AS01B is a proprietary current good manufacturing practices (cGMP) grade adjuvant manufactured by GlaxoSmithKline (GSK) Biologicals. It is a formulation based on liposomes mixed with the immunostimulants monophosphoryl lipid (MPL) and Quillaja saponaria (QS)-21. The immunogenicity and efficacy of this new candidate vaccine will be evaluated in addition to safety.

Details

Lead sponsor	U.S. Army Medical Research and Development Command
Phase	Phase 1
Status	COMPLETED
Enrolment	39
Start date	2014-08
Completion	2015-10

Conditions

• Malaria

Interventions

• FMP012 with AS01B adjuvant system
• P falciparum Controlled Human Malaria Infection (CHMI)

Primary outcomes

• Number of solicited adverse events (AE) — 7 days after each vaccination
• Number of unsolicited AEs — 28 days after each vaccination
• Occurrence of serious adverse events (SAE) at any time during the study period (enrollment to final follow-up visit) — 12 months after vaccination

Countries

United States