Strengthening the Evidence for Policy on the RTS,S/AS01 Malaria Vaccine

Recruiting now

Conditions studied: Malaria

In brief

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.

Key facts

Study ID

NCT05041556

Run by

Kintampo Health Research Centre, Ghana

People needed

9280

Starts

2021-10-18

Expected to finish

2025-04-30

Last updated by the study team

2025-02-28

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Caregiver not willing to provide consent

Where it is running

• Kintampo Health Research Centre — Kintampo, Ghana (enrolling)
• African Research Collaboration for Health Limited — Nairobi, Kenya (enrolling)
• Kenya Medical Research Institute (KEMRI) — Nairobi, Kenya (enrolling)
• College of Medicine, University of Malawi — Blantyre, Malawi (enrolling)

Full record on ClinicalTrials.gov

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