Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
16200 participants
INTERVENTIONAL
2024-05-30
2025-12-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Experimental Group
Three monthly doses of R21/MM will be administered to all eligible residents in the 27 intervention villages (15 in The Gambia and 12 in Burkina Faso), starting from May 2024, with the aim of having completed the vaccination schedule by end of July 2024, before the malaria transmission season starts. A booster vaccine dose will be administered in June 2025 to all eligible individuals who received at least one vaccine dose the previous year. Residents who are eligible but not vaccinated in the previous year, will be offered a complete vaccination schedule, i.e. 3 monthly doses, starting from April. After each vaccination, the first 100 vaccinated individuals will be visited at home daily, for 3 consecutive days, and then at day 7 after the vaccination to collect local and systemic adverse events (AE). Vaccinated individuals (or their parents) will be asked to report to the nurse based in their study village any illness occurring during the 28 days after vaccination.
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.
Control Group
Only standard malaria control measures ( Malaria Chemoprevention (SMC), Intermittent Preventive Treatment during pregnancy (IPTp), Insecticide-Treated bed Nets (ITN), prompt diagnosis and treatment of patients with uncomplicated malaria and Indoor Residual Spraying (IRS)) will be implemented in control villages.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Willingness to comply with trial procedures.
3. Individual written informed consent obtained at the beginning of the study.
Exclusion Criteria
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.
5 Months
99 Years
ALL
Yes
Sponsors
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National Malaria Control Programme, The Gambia
OTHER_GOV
London School of Hygiene and Tropical Medicine
OTHER
Responsible Party
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Principal Investigators
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Umberto D'Alessandro, MD, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
MRCG at LSHTM
Halidou Tinto, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Unit of Nanoro (CRUN)
Edgard Dabira, MD, MSc, PhD
Role: STUDY_DIRECTOR
MRCG at LSHTM
Magloire Natama, PhD
Role: STUDY_DIRECTOR
Clinical Research Unit of Nanoro, Burkina Faso
Locations
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Clinical Research Unit of Nanoro, Burkina Faso
Nanoro, , Burkina Faso
MRC Unit The Gambia at LSHTM
Fajara, , The Gambia
Countries
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Central Contacts
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Facility Contacts
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Magloire Natama, PhD
Role: primary
References
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Dabira ED, Natama HM, Jaiteh F, Grietens KP, Bocoum FY, Ndiath MO, Mohammed N, Gibba B, Hill AVS, Ghani A, Erhart A, Tinto H, D'Alessandro U. Seasonal mass vaccination with R21/Matrix-M for malaria elimination (SERVAL): protocol of the cluster randomised trial. Trials. 2025 Sep 29;26(1):382. doi: 10.1186/s13063-025-09048-6.
Other Identifiers
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LEO29834
Identifier Type: -
Identifier Source: org_study_id
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