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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY
The ongoing Malaria Vaccine Pilot Evaluation (MVPE) is being conducted in Ghana, Malawi and Kenya through community and sentinel hospital surveillance systems and a series of household surveys (to measure vaccine coverage). The Malaria Vaccine Pilot Evaluation-Case Control (MVPE-CC) registered here as observational study is embedded within MVPE comprising case-control studies of clinical and mortality outcomes. Each case will require four controls, and caregiver informed consent will be required prior to study activities. These observational case control studies will measure as complementary information to what is being collected through MVPE: 1. Safety among children who received the malaria vaccine, with focus on cerebral malaria, meningitis and severe malaria 2. The impact of the malaria vaccine on all-cause mortality for boys and girls, AND 3. Promote use of case-control approaches by Expanded Programmes on Immunization (EPI) and malaria control programmes.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 4
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Ghana
Kintampo Health Research Centre
RECRUITING
Kintampo
Kenya
African Research Collaboration for Health Limited
RECRUITING
Nairobi
Kenya Medical Research Institute (KEMRI)
RECRUITING
Nairobi
Malawi
College of Medicine, University of Malawi
RECRUITING
Blantyre
Contact Information
Primary
Thomas Gyan
thomas.gyan@kintampo-hrc.org
0208398541
Time Frame
Start Date:2021-10-18
Estimated Completion Date:2025-04-30
Participants
Target number of participants:9280
Treatments
Case-control study of clinical outcomes
These are children who live in RTS,S implementation areas aged less than 5 years and who were eligible to have received RTS,S based on their date or birth and age, will be eligible to be recruited into the study. Cases will be recruited in sentinel hospitals of the ongoing malaria Vaccine Pilot Evaluation (MVPE). Control for a case will be a child who lives outside a 100-metre radius from the case, matched on date of birth (+/- 1 month of date of birth of the case)
Case-control study of mortality outcome
These will be children who died of any cause excluding accidents or trauma, who are eligible to have received the RTS,S vaccine based on their date of birth and age. Cases will be recruited from the community-based mortality surveillance of MVPE. Control for a mortality case will be a live child who lives outside a 100 metre radius from the case with date of birth +/- 1 month of the date of birth of the case who are eligible to have received the RTS,S vaccine.
Collaborators: PATH, London School of Hygiene and Tropical Medicine, European Vaccine Initiative, Kenya Medical Research Institute, University of Malawi, African Research Collaboration for Health Limited