Clinical trial NCT06860178: Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa
Official title: Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Malaria Vaccine
Keywords: malaria
CPS
pediatric
vaccine
R21
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: R-Evolution Worldwide
name: CNRST Burkina Faso
name: USTTB Mali
name: Liverpool School of Tropical Medicine
First posted: 2025-03-05
Enrollment: 40000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


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:

1. History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;
2. Any history of anaphylaxis in relation to vaccination;
3. Known chronic illness;
4. 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. History of vaccination with another malaria vaccine. -

Primary outcomes:
measure: Malaria Incidence on 5-36 months at 12 months
timeFrame: from enrollment to 12 months
Secondary outcomes:
measure: Malaria incidence among children aged 5-36 months over 24 and 36 months
timeFrame: From enrollment to 2 years after booster
measure: Malaria incidence among children aged 3-59 months over 24 and 36 months
timeFrame: From enrollment to 2 years after booster
measure: Malaria prevalence at peak transmission
timeFrame: From enrollment to 2 years after booster dose
measure: Vaccine coverage
timeFrame: From enrollment to months 24
measure: Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination;
timeFrame: From enrollment to months 4
measure: Acceptability
timeFrame: From 12 months after study start to 36 months
measure: Stakeholder perceptions of the feasibility on the vaccine delivery strategy in each group
timeFrame: From enrollment to months 36
measure: Contextual and behavioural factors impeding or facilitating R21/Matrix-M vaccine uptake
timeFrame: From enrollment to months 24
measure: 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
timeFrame: From enrollment to months 24 and 36
measure: 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
timeFrame: From enrollment to months 36
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest
city: Bamako
country: Mali
facility: University of Sciences Techniques and Technologies of Bamako
Study officials:
References: