Last Updated: 13/12/2024
Safety and immunogenicity AMA1-DiCo with GLA-SE and Alhydrogel in European adults not previously exposed and African adults exposed to the parasite.
Objectives
The study aims:
- To evaluate the safety of 50 µg AMA1-DiCo malaria vaccine candidate with GLA-SE and Alhydrogel® as adjuvant, in healthy European adults not previously exposed to the parasite Plasmodium falciparum and in healthy African adults exposed to the parasite.
- To assess the humoral immune response to the vaccine antigens by measuring the level of IgG in all volunteers.
- To assess the cellular immune response by measuring the T cell cytokines IL-5 and IFNγ production following in vitro stimulation with the vaccine antigens in all volunteers.
National Institute of Health and Medical Research (INSERM), France
This trial is a staggered Phase Ia/Ib, Randomised, Double-blind, Multi-center Centre trial. Two different adjuvants will be assessed, Alhydrogel® and GLA-SE. One dosage of 50 µg/3 injections of AMA1-DiCo will be evaluated for each adjuvant. Sixty six (66) healthy volunteers will be included in the 2 following cohorts (A and B):
Cohort A: 30 Non-exposed European Volunteers (France) Cohort B: 36 Malaria Exposed African Volunteers (Burkina Faso). The non-exposed European volunteers (cohort A) will be randomized in a 1:1 ratio into two groups of 15 volunteers per group. The malaria exposed African volunteers (cohort B) will be randomized in a 1:1 ratio, into two groups of 18 volunteers per group.
European Volunteers: Cohort A (30):
Group A1 (15): 50µg AMA1-DiCo + Alhydrogel® Group A2 (15): 50 µg AMA1-DiCo+ GLA-SE
African Volunteers Cohort B (36) :
Group B1 (18): 50 µg AMA1-DiCo + GLA-SE Group B2 (18): Placebo (isotonic saline solution)
To start recruitment in cohort B (Africa), the safety will be evaluated on the data of all European volunteers until Day 7 after 1st immunization of the last European volunteer Data will be presented to an Independent Data Safety Monitoring Board (DSMB) that will be appointed for this trial.
Study type: Interventional
Enrollment: 66 participant
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel assignment
Masking :Double (participants, investigator)
NCT number: NCT02014727
Phase: Phase I
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