Seasonal R21 Mass Vaccination for Malaria Elimination

Обзор

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.

Подробное описание

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).

Вмешательства

• Биопрепарат 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.

Первичные конечные точки

• Prevalence of malaria infection by PCR in all age groups at peak transmission season (October-November) following the first vaccination with 3 doses. [Срок оценки: At 6 months ( October - November 2024) post first round of vaccination]

Вторичные конечные точки (10)

• Occurrence of Adverse Events (AEs) during follow up. [Срок оценки: Up to 28 days post vaccination]
• Incidence of malaria infection in all age groups during the transmission season following mass vaccination with R21 [Срок оценки: Up to 6 months post the third vaccination round]
• Incidence of clinical malaria in all age groups following mass vaccination with R21. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Up to 6 months post booster dose]
• Incidence of clinical malaria in all age groups following the booster dose. [Срок оценки: Up to 6 months post the third vaccination round]
• Coverage of completed vaccination schedule (3 doses) during the mass vaccination with 3 doses. [Срок оценки: Up to 4 weeks post the third vaccination round]
• Coverage of at least one vaccine dose administered during the mass vaccination with 3 doses [Срок оценки: Up to 4 weeks post the third vaccination round]
• Coverage of the booster dose [Срок оценки: 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. [Срок оценки: Up to 6 months post booster dose]

Критерии участия

Критерии включения

• Age≥ 5 months.
• Willingness to comply with trial procedures.
• Individual written informed consent obtained at the beginning of the study.

Критерии исключения

• Pregnancy
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone.
• Any history of anaphylaxis in relation to vaccination.
• Known chronic illness.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Burkina Faso · 1 центр

• Clinical Research Unit of Nanoro, Burkina Faso — Nanoro

The Gambia · 1 центр

• MRC Unit The Gambia at LSHTM — Fajara

Публикации

• 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. PMID 41024138

Идентификаторы

NCT: NCT06578572 · LEO29834

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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