Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa

Обзор

This is a multi-site, multi-disciplinary, Phase-4 two-arm cluster-randomised non-inferiority trial in Burkina Faso and Mali to evaluate the effectiveness and real-life impact of a novel integrated delivery strategy of the R21 malaria vaccine alongside SMC among children in areas with highly seasonal malaria transmission. In this study, a cluster is defined as the catchment area of a health centre. Clusters will be randomised to receive either year-round age-based routine EPI vaccination for children aged 5-36 months ("Routine EPI Vaccination") in Burkina Faso or an annual campaign of the 3-dose primary series in children aged 5-36 months prior to the malaria season and SMC delivery (''Routine Pre-SMC vaccination'') in Mali versus an annual campaign of the 3-dose primary series aligned with SMC distribution in children aged 3-59 months ("Integrated SMC Vaccination") in each country. Effectiveness will be assessed in terms of clinical malaria, vaccine coverage, acceptability, feasibility, and cost-effectiveness. Malaria incidence will be determined using routine surveillance activities for clinical malaria detection and reporting in each country. Cross-sectional surveys will be conducted to determine the prevalence of parasitaemia in the communities. In addition, the acceptability, feasibility, coverage and cost-effectiveness of the different delivery systems of R21/Matrix-M will be assessed.

Вмешательства

• Другое Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 months
  in the intenvention arm, the children will get the vaccine R21 Matrix M together with the CPS

Первичные конечные точки

• Malaria Incidence on 5-36 months at 12 months [Срок оценки: from enrollment to 12 months]

Вторичные конечные точки (10)

• Malaria incidence among children aged 5-36 months over 24 and 36 months [Срок оценки: From enrollment to 2 years after booster]
• Malaria incidence among children aged 3-59 months over 24 and 36 months [Срок оценки: From enrollment to 2 years after booster]
• Malaria prevalence at peak transmission [Срок оценки: From enrollment to 2 years after booster dose]
• Vaccine coverage [Срок оценки: From enrollment to months 24]
• Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination; [Срок оценки: From enrollment to months 4]
• Acceptability [Срок оценки: From 12 months after study start to 36 months]
• Stakeholder perceptions of the feasibility on the vaccine delivery strategy in each group [Срок оценки: From enrollment to months 36]
• Contextual and behavioural factors impeding or facilitating R21/Matrix-M vaccine uptake [Срок оценки: From enrollment to months 24]
• Stakeholders and caregivers perceptions of the factors that enhance and/or constrain the succesful co,pletion of four doses of R21 and the key drivers of vaccination coverage [Срок оценки: From enrollment to months 24 and 36]
• Incremental costs (per child vaccinated) and cost-effectiveness (per malaria case and separately, per DALY averted) of each vaccination strategy, calculated from a societal perspective [Срок оценки: From enrollment to months 36]

Критерии участия

Критерии включения

Control arms :

• Children aged 5-36 months in Burkina Faso and Mali at the time of first study vaccination;
• Resident in the catchment area of a health centre assigned to the control arm;
• Willingness to comply with the study procedures;
• Written informed consent from Parent/Guardian.

Intervention arms :

• Children aged 3-59 months at the time of first study vaccination;
• Resident in the catchment area of a health centre assigned to the intervention arm;
• Willingness to comply with the study procedures;
• Written informed consent from Parent/Guardian.

Критерии исключения

• History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;
• 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;
• History of vaccination with another malaria vaccine. -

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

• Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest — Ouagadougou

Mali · 1 центр

• University of Sciences Techniques and Technologies of Bamako — Bamako

Идентификаторы

NCT: NCT06860178 · IMVACS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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