Last Updated: 30/04/2024
Safety and protective efficacy of synthetic PvCSP vaccine in naïve and pre-immune Colombian volunteers
Objectives
The objective of this study is to compare two groups of volunteers (naive and previously exposed to malaria) vaccinated with three doses of a synthetic derivative of the circumsporozoite protein (CSP) of Plasmodium vivax to determine their protective efficacy.
Malaria Vaccine and Drug Development Center (MVDC), Colombia
This study is a prospective controlled, blinded clinical trial, designed to establish the protective efficacy induced by the vaccine PvCSP between human volunteers with and without a history of malaria. Volunteers will be recruited in Cali, Colombia, and Quibdó, Colombia.
Study type: Interventional
Enrollment: 120 participants
Primary purpose: Prevention
Allocation : Randomized
Interventional Model: Parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
NCT number: NCT04739917
Phase: Phase II
Article: Antibody-induced ultrastructural changes of malarial sporozoitesArticle: Widespread reactivity of human sera with a variant repeat of the circumsporozoite protein of Plasmodium vivaxArticle: A retrospective examination of sporozoite- and trophozoite-induced infections with Plasmodium falciparum in patients previously infected with heterologous species of Plasmodium: effect on development of parasitologic and clinical immunity
