Last Updated: 02/12/2024
Evaluation of the Protective Efficacy of a Vaccine Derived From the Synthetic CS Protein of Plasmodium Vivax
Objectives
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 circumsporozoite protein (CSP) 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.
Malaria Vaccine and Drug Development Center (MVDC), Colombia
This study produced a prospective controlled, blinded clinical trial in 2021, 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.
ClinicalTrials.gov Identifier: NCT02083068
Study Phase: Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
ClinicalTrials.gov Identifier: NCT04739917
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
May 2014 — Aug 2015
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