Malaria VaccinePhase 4IMVACSNCT06860178
Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa
A Phase 4 study testing Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 months in people with Malaria Vaccine, run by Epicentre at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria Vaccine
- What is being tested?
- Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 months
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Jun 2025to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 :
Show all 10Show fewer
- 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.
Who cannot join
- 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. -
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Burkina Faso1 site, 1 recruiting
- Recruiting
Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest
Ouagadougou
Natama Hamtandi Magloire, +226 57471950, natamagloire@gmail.com
Natama Hamtandi Magloire
Mali1 site, 1 recruiting
- Recruiting
University of Sciences Techniques and Technologies of Bamako
Bamako
Kassoum Kayentao, +223 76460173, kayentao@icermali.org
Kassoum Kayentao
About this study
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.
- Conditions
- Malaria Vaccine
- Being tested
- Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 months
- Keywords
- malaria, CPS, pediatric, vaccine, R21
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 monthsOther
in the intenvention arm, the children will get the vaccine R21 Matrix M together with the CPS
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Children aged 5-36 months will receive R21 via routine EPI vaccination (Year round in Burkina faso, or prior to the malaria season and SMC delivery in Mali) |
| Integrated SMC Vaccination | Other | Children aged 3-59 months will receive 3-dose primary series aligned with SMC distribution in an annual campaign Receives: Other: Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria Incidence on 5-36 months at 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
Measured: from enrollment to 12 months
Secondary outcomes (10)
Malaria incidence among children aged 5-36 months over 24 and 36 months
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;
Measured: From enrollment to 2 years after booster
Malaria incidence among children aged 3-59 months over 24 and 36 months
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
Measured: From enrollment to 2 years after booster
Malaria prevalence at peak transmission
Malaria prevalence at peak transmission in November after SMC campaigns in 2025 and 2026
Measured: From enrollment to 2 years after booster dose
Vaccine coverage
Pourcentage of children who has received 3 or 4 doses at 24 months post 1st vaccination
Measured: From enrollment to months 24
Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination;
Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination
Measured: From enrollment to months 4
Acceptability
Qualitative interviews and FGDs among policy makers, health managers, health providers and caregivers
Measured: From 12 months after study start to 36 months
Stakeholder perceptions of the feasibility on the vaccine delivery strategy in each group
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.
Measured: From enrollment to months 36
Contextual and behavioural factors impeding or facilitating R21/Matrix-M vaccine uptake
Interviews and FGD - will be explained in a parallel protocol
Measured: 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
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
Measured: 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
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).
Measured: From enrollment to months 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start10 Jun 2025
- Primary completionMay 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- R-Evolution Worldwide, CNRST Burkina Faso, USTTB Mali, Liverpool School of Tropical Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860178
- Sponsor's protocol ID
- IMVACS
- Acronym
- IMVACS
- Status last verified
- Aug 2025
- First submitted
- 20 Jan 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa
- ClinicalTrials.gov ID
- NCT06860178
- Acronym / sponsor ID
- IMVACS / IMVACS
- Conditions
- Malaria Vaccine
- Keywords
- malaria, CPS, pediatric, vaccine, R21
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- R-Evolution Worldwide, CNRST Burkina Faso, USTTB Mali, Liverpool School of Tropical Medicine
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Children aged 5-36 months will receive R21 via routine EPI vaccination (Year round in Burkina faso, or prior to the malaria season and SMC delivery in Mali) |
| Integrated SMC Vaccination | Other | Other: Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 monthsChildren aged 3-59 months will receive 3-dose primary series aligned with SMC distribution in an annual campaign |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
- Children aged 3-59 months at the time of first study vaccination;
Key exclusion criteria (5 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 monthsin the intenvention arm, the children will get the vaccine R21 Matrix M together with the CPS | Other | Integrated SMC Vaccination |
Primary outcome
Malaria Incidence on 5-36 months at 12 months
Time frame: 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
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 months in people with Malaria Vaccine, run by Epicentre at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso, Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie Briand (+331 40 21 55 55, valerie.briand@epicentre.msf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malaria Incidence on 5-36 months at 12 months (time frame: from enrollment to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.