This is a cluster randomized trial to determine the impact of seasonal R21/MM massvaccination (all ages) on malaria transmission and morbidity. Fifty-four villages (30 inThe Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21or no mass vaccination.The primary objective is to compare in intervention and control clusters the prevalenceof 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 changesin malaria transmission following mass vaccination with R21.
This is a cluster-randomized controlled trial. 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. Therefore,15 medium-sized (200-600 people) villages in The Gambia and 12
medium-sized (200-600 people) villages in Burkina Faso will receive the intervention. All
study villages will receive standard control intervention, e.g., seasonal malaria
chemoprevention, insecticide-treated bed nets, implemented by the National Malaria
Control Program and according the National Strategic Plan for malaria control. Mass
vaccination will be completed before the start of the malaria transmission season, i.e.
July.
A cross-sectional survey to estimate malaria prevalence will be implemented at peak
transmission, both following the mass vaccination with 3 doses (first year) and the
booster dose (second year). A blood sample will be collected during the malaria
transmission season from a cohort of randomly selected individuals to determine the
incidence of malaria infection. A system of passive case detection to determine the
incidence of clinical malaria will be set up throughout the study period, with special
attention to the malaria transmission season (July-December).
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.
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.
Clinical Research Unit of Nanoro, Burkina Faso
Nanoro, Burkina Faso
MRC Unit The Gambia at LSHTM
Fajara, Gambia
Umberto D'Alessandro, MD, DHTM, MSc, PhD
+220449544 - 4001
Umberto.Dalessandro@lshtm.ac.uk
Anette Erhart, MD, MSs, PhD
Annette.Erhart@lshtm.ac.uk