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| Name | Class |
|---|---|
| National Malaria Control Programme, The Gambia | OTHER_GOV |
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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:
The exploratory objective is to determine whether serological markers can detect changes in 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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. |
|
| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R21Matrix M | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of malaria infection by PCR in all age groups at peak transmission season (October-November) following the first vaccination with 3 doses. | A cross-sectional survey will be conducted at peak transmission in October -November 2024 to determine prevalence of malaria infection. | At 6 months ( October - November 2024) post first round of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Events (AEs) during follow up. |
| Up to 28 days post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Umberto D'Alessandro, MD, DHTM, MSc, PhD | Contact | +220449544 | 4001 | Umberto.Dalessandro@lshtm.ac.uk |
| Anette Erhart, MD, MSs, PhD | Contact | Annette.Erhart@lshtm.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Umberto D'Alessandro, MD, MSc, PhD | MRCG at LSHTM | Principal Investigator |
| Halidou Tinto, PhD | Clinical Research Unit of Nanoro | Principal Investigator |
| Edgard Dabira, MD, MSc, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Unit of Nanoro, Burkina Faso | Recruiting | Nanoro | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41024138 | Derived | 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. |
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Anonymised IPD data will be made available from one month after trial publication and for a further 24 months
1 month after the publication date and for a further 24 months
Application to the principal investigator with a justification of the request
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| Incidence of malaria infection in all age groups during the transmission season following mass vaccination with R21 | Incidence of malaria infection will be determined by molecular analyses (PCR) in a cohort of 20 individuals per village in Burkina Faso and 30 individuals per villages in The Gambia through monthly home visits ( following mass vaccination with R21). | Up to 6 months post the third vaccination round |
| Incidence of clinical malaria in all age groups following mass vaccination with R21. | A passive case detection of clinical malaria throughout the study period, with special attention to the malaria transmission season (July-December) | Up to 6 months post the third vaccination round |
| Prevalence of malaria infection by PCR in all age groups at peak transmission following the booster dose. | A cross-sectional survey will be conducted at peak transmission in October -November 2025 to determine prevalence of malaria infection. | At 6 months ( October - November 2025) post booster dose |
| Incidence of malaria infection in all age groups during the transmission season following the booster dose. | Incidence of malaria infection will be determined by molecular analyses (PCR) in a cohort of 20 individuals per village in Burkina Faso and 30 individuals per villages in The Gambia through monthly home visits ( following the booster dose). | Up to 6 months post booster dose |
| Incidence of clinical malaria in all age groups following the booster dose. | Passive detection of clinical malaria both at the community and at health facility level | Up to 6 months post the third vaccination round |
| Coverage of completed vaccination schedule (3 doses) during the mass vaccination with 3 doses. | Coverage of completed vaccination schedule (3 doses) during the mass vaccination with 3 doses. | Up to 4 weeks post the third vaccination round |
| Coverage of at least one vaccine dose administered during the mass vaccination with 3 doses | Coverage of at least one vaccine dose | Up to 4 weeks post the third vaccination round |
| Coverage of the booster dose | Coverage of the booster dose | Up to 4 weeks post booster dose |
| Cost of vaccine administration and cost effectiveness, both for the mass vaccination campaign with 3 doses and the booster dose. | A cross sectional survey will be carried out at the beginning of the project in both study arms to estimate the cost of seeking care among households and the costs supported by the health facility. Cost of mass vaccination will be collected for each round. | Up to 6 months post booster dose |
| MRCG at LSHTM |
| Study Director |
| Magloire Natama, PhD | Clinical Research Unit of Nanoro, Burkina Faso | Study Director |
| MRC Unit The Gambia at LSHTM | Recruiting | Fajara | 273 | The Gambia |
|
| D000079426 |
| Vector Borne Diseases |