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Recruiting NCT06860178

Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa

Phase IV Interventional Malaria Vaccine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 months.
Who it may be relevant to
Registry conditions: Malaria Vaccine. Basic parameters: 3 months — 59 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Burkina Faso, Mali
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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

Primary outcome measures

  • Malaria Incidence on 5-36 months at 12 months [Time frame: from enrollment to 12 months]
Secondary outcome measures (10)
  • Malaria incidence among children aged 5-36 months over 24 and 36 months [Time frame: From enrollment to 2 years after booster]
  • Malaria incidence among children aged 3-59 months over 24 and 36 months [Time frame: From enrollment to 2 years after booster]
  • Malaria prevalence at peak transmission [Time frame: From enrollment to 2 years after booster dose]
  • Vaccine coverage [Time frame: From enrollment to months 24]
  • Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination; [Time frame: From enrollment to months 4]
  • Acceptability [Time frame: From 12 months after study start to 36 months]
  • Stakeholder perceptions of the feasibility on the vaccine delivery strategy in each group [Time frame: From enrollment to months 36]
  • Contextual and behavioural factors impeding or facilitating R21/Matrix-M vaccine uptake [Time frame: 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 [Time frame: 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 [Time frame: From enrollment to months 36]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

  • 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. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Burkina Faso · 1 center
  • Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest — Ouagadougou
Mali · 1 center
  • University of Sciences Techniques and Technologies of Bamako — Bamako

Identifiers

NCT: NCT06860178 · IMVACS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗