drugset / Trial / NCT01157897
Study of VMP001 and AS01B (Adjuvant Formulation) in Healthy Malaria-Naïve Adults
Phase 1/2
Completed
41 enrolled
U.S. Army Medical Research and Development Command
GlaxoSmithKline · collabThe PATH Malaria Vaccine Initiative (MVI) · collabUnited States Department of Defense · collabWalter Reed Army Institute of Research (WRAIR) · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
This is a first-in-humans safety, immunogenicity and efficacy study with recombinant protein VMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine. This open label study will be performed in malaria-naïve adults in the United States. Three doses of VMP001 formulated in AS01B (adjuvant system) will be given intramuscularly at different intervals followed by a challenge with P. vivax infected mosquitoes. Safety, immunogenicity and efficacy parameters will be studied.
Timeline
- Start
- 2010-07
- Primary completion
- 2012-01
- Completion
- 2012-01
Publications
- Results Bennett JW, Pybus BS, Yadava A, Tosh D, Sousa JC, McCarthy WF, Deye G, Melendez V, Ockenhouse CF. Primaquine failure and cytochrome P-450 2D6 in Plasmodium vivax malaria. N Engl J Med. 2013 Oct 3;369(14):1381-2. doi: 10.1056/NEJMc1301936. No abstract available.
- Kamau E, Bennett JW, Yadava A. Safety and Tolerability of Mosquito Bite-Induced Controlled Human Infection with Plasmodium vivax in Malaria-Naive Study Participants-Clinical Profile and Utility of Molecular Diagnostic Methods. J Infect Dis. 2022 Jan 5;225(1):146-156. doi: 10.1093/infdis/jiab332.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VMP001 | Protein / enzyme biologic | 15 ug | Intramuscular |
| Subject | VMP001 | Protein / enzyme biologic | 30 ug | Intramuscular |
| Subject | VMP001 | Protein / enzyme biologic | 60 ug | Intramuscular |
| Background | AS01B | Other / unclassified | 500 ml | Intramuscular |