Last Updated: 02/12/2024
PfSPZ-CVac and PfSPZ Vaccine in 1-12 years old African children naturally exposed to malaria parasites
Objectives
The objective of this study is to directly compare, for the first time in children, PfSPZ-CVac with PfSPZ Vaccine against placebo in the most malaria-affected population: African children under high-level exposure to P. falciparum malaria.
This study is part of the BONNECHANCE study, a promising clinical trial that delivers important information on the safety, tolerability, and efficacy of the PfSPZ vaccines. The aim of the trial is to deliver critical data for approval of PfSPZ vaccines.
Malaria is the most important parasitic disease and a major cause of child death in highly endemic regions of sub-Saharan Africa. Vaccines would be an essential tool to control and eliminate malaria as well as to contain drug-resistant parasite strains. So far, only whole sporozoite-based immunization has shown high-grade and prolonged protective efficacy. To transform this concept into a vaccine, Sanaria Inc. developed methods to produce aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ) in compliance with current good manufacturing practices (cGMP) for immunisation and assessment of antimalarial interventions using highly standardized controlled human malaria infection (CHMI). PfSPZ can be used for immunization using two major approaches: 1) immunization with fully viable PfSPZ (PfSPZ Challenge) under chemoprophylaxis (together termed PfSPZ Chemoprophylaxis Vaccine PfSPZ-CVac approach), 2) immunization with radiation-attenuated PfSPZ (PfSPZ Vaccine). They are the only two malaria vaccine approaches that have ever shown >90% protection against CHMI.
Study type: Interventional
Enrollment: 484 participants
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Factorial assignment
Masking: Double
Trial Number: PACTR201712002879427
Phase: Phase I
Clinical trial registrationPACTR registration Project details
Mar 2018 — Feb 2022
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