drugset / Trial / NCT02083068
Evaluation of the Protective Efficacy of a Vaccine Derived From the Synthetic CS Protein of Plasmodium Vivax
Phase 2
Completed
32 enrolled
Malaria Vaccine and Drug Development Center
The Administrative Department of Science, Technology and Innovation, Colciencias · collab
RandomizedParallel-groupTriple-blindBasic science
Summary
This is a randomized, double-blind, controlled, which seeks to compare two groups of volunteers (naive and previously exposed to malaria) who were made 3 immunizations with a synthetic derivative of the CS protein of Plasmodium vivax in order to determine their protective efficacy. Then volunteers will be subject to an infectious challenge to assess the infectivity of gametocytes in the blood early stage of P. vivax in Anopheles albimanus mosquitoes.
Timeline
- Start
- 2014-08
- Primary completion
- 2015-09
- Completion
- 2017-07
Publications
- Background Herrera S, Solarte Y, Jordan-Villegas A, Echavarria JF, Rocha L, Palacios R, Ramirez O, Velez JD, Epstein JE, Richie TL, Arevalo-Herrera M. Consistent safety and infectivity in sporozoite challenge model of Plasmodium vivax in malaria-naive human volunteers. Am J Trop Med Hyg. 2011 Feb;84(2 Suppl):4-11. doi: 10.4269/ajtmh.2011.09-0498.
- Arevalo-Herrera M, Gaitan X, Larmat-Delgado M, Caicedo MA, Herrera SM, Henao-Giraldo J, Castellanos A, Devaud JC, Pannatier A, Onate J, Corradin G, Herrera S. Randomized clinical trial to assess the protective efficacy of a Plasmodium vivax CS synthetic vaccine. Nat Commun. 2022 Mar 25;13(1):1603. doi: 10.1038/s41467-022-29226-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PvCS N+C | Vaccine | 60 ug | — |
| Subject | PvCS N+C+R | Vaccine | 60 ug | — |