Evaluating the RTS,S malaria vaccine's safety and effectiveness
Strengthening the Evidence for Policy on the RTS,S/AS01 Malaria Vaccine: Assessment of Safety and Effectiveness Using Case-control Studies Embedded in the Malaria Vaccine Pilot Evaluation
This study is testing how safe and effective the RTS,S malaria vaccine is for young children in Ghana, Malawi, and Kenya.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 9280 (estimated) |
| Ages | 6 Months to 59 Months |
| Sex | All |
| Sponsor | Kintampo Health Research Centre, Ghana Academic / other |
| Locations | 4 sites (Kintampo and 3 other locations) |
| Trial ID | NCT05041556 on ClinicalTrials.gov |
What this trial studies
This observational study is part of the Malaria Vaccine Pilot Evaluation (MVPE) and aims to assess the safety and effectiveness of the RTS,S/AS01 malaria vaccine through case-control studies in Ghana, Malawi, and Kenya. It will involve recruiting children aged 6 to 59 months from sentinel hospitals and surrounding communities, where each case will be matched with four controls. The study will focus on measuring safety outcomes, including severe malaria and all-cause mortality, while also promoting the use of case-control methodologies in immunization programs.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 59 months living in areas where the RTS,S/AS01 vaccine is being implemented.
Not a fit: Patients who are not residents in the RTS,S/AS01 implementation areas or whose caregivers do not provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical evidence to support the safe implementation of the RTS,S malaria vaccine, potentially reducing malaria-related morbidity and mortality in children.
How similar studies have performed: Other studies evaluating malaria vaccines have shown promising results, indicating that this approach is built on existing evidence but focuses on a specific case-control methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willingness to participate in study evidenced by written informed consent provided by an adult caregiver * Resident in an RTS,S/AS01 implementation area within the catchment area of MVPE sentinel hospitals * Eligible, based on date of birth and age, to have received RTSS/AS01 * Meets the case or control definitions above. Exclusion Criteria: * Caregiver not willing to provide consent
Where this trial is running
Kintampo and 3 other locations
- Kintampo Health Research Centre — Kintampo, Ghana (Recruiting)
- African Research Collaboration for Health Limited — Nairobi, Kenya (Recruiting)
- Kenya Medical Research Institute (KEMRI) — Nairobi, Kenya (Recruiting)
- College of Medicine, University of Malawi — Blantyre, Malawi (Recruiting)
Study contacts
- Principal investigator: Kwaku Poku Asante, PhD — Kintampo Health Research Centre, Ghana
- Study coordinator: Thomas Gyan
- Email: thomas.gyan@kintampo-hrc.org
- Phone: 0208398541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.