Malaria Vaccine
Conditions
Keywords
malaria, CPS, pediatric, vaccine, R21
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.
Interventions
OTHERAnnual 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
Sponsors
R-Evolution Worldwide
CNRST Burkina Faso
USTTB Mali
Liverpool School of Tropical Medicine
Epicentre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 59 Months
Healthy volunteers
Yes
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malaria Incidence on 5-36 months at 12 months | from enrollment to 12 months | Malaria incidence among children aged 5-36 months over 12 months post first dose using routine surveillance activities for clinical malaria detection and reporting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Malaria incidence among children aged 3-59 months over 24 and 36 months | From enrollment to 2 years after booster | Malaria incidence among children aged 3-59 months over 24 and 36 months post first dose using routine surveillance activities for clinical malaria detection and reporting |
| Malaria prevalence at peak transmission | From enrollment to 2 years after booster dose | Malaria prevalence at peak transmission in November after SMC campaigns in 2025 and 2026 |
| Vaccine coverage | From enrollment to months 24 | Pourcentage of children who has received 3 or 4 doses at 24 months post 1st vaccination |
| Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination; | From enrollment to months 4 | Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination |
| Malaria incidence among children aged 5-36 months over 24 and 36 months | From enrollment to 2 years after booster | Malaria incidence among children aged 5-36 months over 24 and 36 months post first dose using routine surveillance activities for clinical malaria detection and reporting; |
| Stakeholder perceptions of the feasibility on the vaccine delivery strategy in each group | From enrollment to months 36 | Acceptability and feasibility studies will use qualitative longitudinal study (QLS) research methods. We will apply an ecological framework approach with emphasis on the interplay and inter-dependency between individual, interpersonal, organizational, and policy levels. Qualitative data will be collected through ethnographic immersion, in-depth interviews, group interviews and focus group discussions. No quantitative measurements will be made. |
| Contextual and behavioural factors impeding or facilitating R21/Matrix-M vaccine uptake | From enrollment to months 24 | Interviews and FGD - will be explained in a parallel protocol |
| 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 | From enrollment to months 24 and 36 | The study will cover a full, two-year R21/Matrix-M delivery cycle with data collection at two time points in each arm: soon after the primary series is delivered, and soon after the booster dose is provided a year later. This longitudinal approach will enable us to explore and chart dynamic processes as they occur, barriers and facilitators, and acceptability over time. It is inherently suitable for studying R21/Matrix-M introduction, requiring prolonged and repeated involvement by patients and providers. This approach is also necessary to explore the drivers of vaccine hesitancy which is not a static state; vaccine decision-making changes over time as caregivers experience different influences and nudges along the way. Qualitative data will be collected through ethnographic immersion, in-depth interviews, group interviews and focus group discussions to explore factors in the service delivery, household, and broader social environments that will lead to R21 adoption and adherence. A |
| 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 | From enrollment to months 36 | Costs associated with the different vaccination strategies will be estimated by collecting data on direct and indirect costs to health systems and opportunity costs to vaccinees and their caregivers (beneficiaries). Beneficiary costs will be collected during household surveys, via case report forms developed to collect data on direct costs (transport, food, medication) and indirect costs (time and income loss) incurred by their household related to each intervention arm. Provider costs will be collected using custom built spreadsheets structured to comprehensively capture the resources used for all intervention delivery related activities (excluding research activities) by cost category (person time, equipment, consumables including vaccines, storage, transport, overheads and other costs) by arm. Malaria incidence estimates (primary clinical outcome) will be used to calculate malaria cases and DALYs averted by arm, adjusted for intervention coverage (using the coverage survey data). |
| Acceptability | From 12 months after study start to 36 months | Qualitative interviews and FGDs among policy makers, health managers, health providers and caregivers |
Countries
Burkina Faso, Mali
Contacts
Primary ContactValérie Briand
Backup ContactSoazic Gardais
Outcome results
None listed