At a glance
ClinicalIndex Comparison Record- ✓Age at least 5 months
- ✓Willingness to comply with trial procedures
- ✓Written informed consent obtained at study beginning
- ✕Pregnancy
- ✕History of allergic disease or reactions to vaccine components including Kathon, neomycin, betapropiolactone
- ✕Any history of anaphylaxis in relation to vaccination
- ✕Known chronic illness
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT06578572Phase 3RecruitingUpdate OverdueUpdated 22mo ago · Completion was 18mo agoSeasonal R21 Mass Vaccination for Malaria Elimination
In Brief
A Phase 3 clinical trial evaluating R21Matrix M for Malaria. Currently recruiting, targeting 16,200 participants across 2 sites in 2 countries.
Signals
Detailed Summary
This is a cluster randomized trial to determine the impact of seasonal R21/MM mass vaccination (all ages) on malaria transmission and morbidity. Fifty-four villages (30 in The Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21 or no mass vaccination. The primary objective is to compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after seasonal mass vaccination with R21 (3 monthly doses). Secondary objectives are: 1. To assess the safety and tolerability of R21 through spontaneously reported adverse events. 2. To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following seasonal mass vaccination with R21 (3 monthly doses). 3. To compare in intervention and control clusters the incidence of clinical malaria (all age groups) after seasonal mass vaccination with R21 (3 monthly doses). 4. To compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after one booster dose of R21. 5. To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following one booster dose of R21. 6. To compare in intervention and control clusters the incidence of clinical malaria (all age groups), after one booster dose of R21. 7. To determine the coverage of seasonal mass vaccination with R21 (primary series of three vaccinations and booster) in intervention clusters and related socio-cultural factors 8. To estimate the cost of seasonal mass vaccination with R21 administration. 9. To estimate the cost-effectiveness of seasonal mass vaccination with R21 compared to standard malaria control measures. The exploratory objective is to determine whether serological markers can detect changes in malaria transmission following mass vaccination with R21.
Study Details
Timeline
Interventions
A mixture of R21/Matrix M at a dose of 5 μg (for children up to 14 years of age) or 10 μg ( for individuals ≥ 15 years old) with 50 μg of Matrix-M will be administered monthly over 3 months (one dose per month over 3 months (May, June, and July 2024) plus a booster dose in June 2025.