drugset / Trial / NCT02174978
Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) to Evaluate the Safety and Efficacy of the Plasmodium Falciparum Vaccine Candidate FMP012 Administered Intramuscularly With AS01B Adjuvant System in Healthy Malaria-Naïve Adults
Phase 1
Completed
39 enrolled
U.S. Army Medical Research and Development Command
GlaxoSmithKline · collabMilitary Infectious Diseases Research Program (MIDRP) · collabUnited States Agency for International Development (USAID) · collabWalter Reed Army Institute of Research (WRAIR) · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
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.
Timeline
- Start
- 2014-08
- Primary completion
- 2015-06
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FMP012 | Vaccine | 10 ug | Intramuscular |
| Subject | FMP012 | Vaccine | 30 ug | Intramuscular |