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

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.

Conditions

• Malaria

Interventions

OTHER

Case-control study of clinical outcomes

A case-control questionnaire will be administered at the home of cases and controls

OTHER

Case-control study of mortality outcome

A case-control questionnaire will be administered at the home of cases and controls

Sponsors & Collaborators

• European Vaccine Initiative

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• African Research Collaboration for Health Limited

  collaborator UNKNOWN

• Kenya Medical Research Institute

  collaborator OTHER

• University of Malawi

  collaborator OTHER

• PATH

  collaborator OTHER

• Kintampo Health Research Centre, Ghana

  lead OTHER

Principal Investigators

• Kwaku Poku Asante, PhD · Kintampo Health Research Centre, Ghana

• Don Mathanga, PhD · College of Medicine, University of Malawi, Malawi

• Samuel Akech, PhD · African Research Collaboration for Health Limited, Kenya

• Simon Kariuki, PhD · Kenya Medical Research Institute

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-18

Primary Completion

2025-04-30

Completion

2025-04-30

Countries

• Ghana
• Kenya
• Malawi

Study Locations