Last Updated: 02/12/2024
Phase 1 of CAF01 and aluminum hydroxide as adjuvants for vaccine candidate GMZ2 in health adult African volunteers
Objectives
The primary objective of this study is to establish a regimen of GMZ2-CAF01, which is safe and well tolerated.
Secondary objectives are:
1. to establish a regimen of GMZ2-CAF01 that reduces parasite multiplication upon controlled human malaria infection (CHMI)
2. to establish a regimen of GMZ2-CAF01 that induces a superior anti-GMZ2 antibody-response compared to GMZ2-alum and a control vaccine (Rabies).
GMZ2 is a vaccine candidate targeting the asexual blood stage of the malaria parasite life cycle. This candidate shows excellent safety and tolerability, and modest immunogenicity when adjuvanted with aluminum in phase 1 and 2 trials. To improve the immune response to the vaccine and induce better protection, this trial proposes to combine GMZ2 with a novel adjuvant. CAF01 has demonstrated good safety, tolerability, and immunogenicity when combined with various vaccines in previous trials. This trial plans to compare GMZ2 adjuvanted with Alum, CAF01, and placebo in varying doses with and without subsequent Controlled Human Malaria Infection (CHMI) to assess efficacy. Primary Objective: Establish a regimen of GMZ2-CAF01, which is safe and well tolerated. Secondary Objective: Establish a regimen of GMZ2-CAF01 that reduces parasite multiplication upon CHMI. Establish a regimen of GMZ2-CAF01 that induces a superior anti-GMZ2 antibody response compared to GMZ2-alum and a control vaccine (Rabies).
Study type: Interventional
Enrollment: 50 participant
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel assignment
Masking : Quadruple (Participant, Investigator, Care provider, Outcome assessor)
Trial Number: PACTR201503001038304
Phase: Phase I
Feb 2015 — Jan 2016
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