RECRUITINGPhase 3INTERVENTIONAL

Seasonal R21 Mass Vaccination for Malaria Elimination

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age≥ 5 months. 2. Willingness to comply with trial procedures. 3. Individual written willing to sign a consent form obtained at the beginning of the study. Who Should NOT Join This Trial: 1. Pregnancy 2. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone. 3. Any history of anaphylaxis in relation to vaccination. 4. Known chronic illness. 5. Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age≥ 5 months. 2. Willingness to comply with trial procedures. 3. Individual written informed consent obtained at the beginning of the study. Exclusion Criteria: 1. Pregnancy 2. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone. 3. Any history of anaphylaxis in relation to vaccination. 4. Known chronic illness. 5. Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Treatments Being Tested

BIOLOGICAL

R21Matrix M

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.

Locations (2)

Clinical Research Unit of Nanoro, Burkina Faso

Nanoro, Burkina Faso

MRC Unit The Gambia at LSHTM

Fajara, The Gambia