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

NCT05041556 | Recruiting DMC

• 1 other identifier: GHS-ERC 006/01/21
• Study Type: observational
• Target: 9,280
• Locations: 3 countries
• Sites: 4

Brief 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. 1.Safety among children who received the malaria vaccine, with focus on cerebral malaria, meningitis and severe malaria
2. 2.The impact of the malaria vaccine on all-cause mortality for boys and girls, AND
3. 3.Promote use of case-control approaches by Expanded Programmes on Immunization (EPI) and malaria control programmes.

Conditions

Malaria

Keywords

Malaria; Vaccines; Case-control; Safety; Mortality

Outcome Measures

Primary Outcomes (4)

• Number of children admitted with a diagnosis of probable and confirmed meningitis

  Number of children with probable and confirmed meningitis. A case of meningitis will include probable or confirmed meningitis, defined as a child eligible to have received the RTS,S vaccine and admitted with clinical signs of meningitis, CSF that is turbid, cloudy or purulent or with CSF leukocyte count \>10 cells/mm3, or with a pathogen isolated at the central reference laboratory from CSF . A control to a meningitis case is defined as a child who lives outside a 100 metre radius from the case with date of birth within +/- 1 month of date of birth of the case, recruited concurrently with the case

  Through study completion, an average of 1 year

• Number of children admitted with a diagnosis of severe malaria

  Number of children admitted with a diagnosis of severe malaria. A case of severe malaria is defined as a child who was eligible to have received RTS,S and diagnosed as severe malaria based on the presence of Plasmodium falciparum parasitaemia detected by microscopy or rapid diagnostic test, with impaired consciousness, convulsions, respiratory distress, severe malarial anaemia (hemoglobin level \< 8g/dL or requiring blood transfusion for anaemia) or cerebral malaria \[ P. falciparum parasitaemia with impaired consciousness (Glasgow coma score \<11 (children 2 years of age and above) or a Blantyre coma score \<3 in children under 2 years or assessed as P or U on AVPU score) with a clinical diagnosis of cerebral malaria and CSF findings not consistent with meningitis\]. A control for a severe malaria case will be defined as 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

  Through study completion, an average of 1 year

• The number of deaths of any cause

  The number of deaths of any cause. Cases 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. A control to a mortality case will be defined as 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.

  Through study completion, an average of 1 year

• Number of deaths in children by gender

  Number of deaths in children stratified by gender in children aged 6-59 months

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• Number of children with a diagnosis of severe malaria in relation to the 4th dose of RTS,S

  Through study completion, an average of 1 year

• Number of children with a diagnosis of cerebral malaria in relation to the 4th dose of RTS,S

  Through study completion, an average of 1 year

• Number of deaths of any cause in relation to the 4th dose of RTS,S

  Through study completion, an average of 1 year

• Number of deaths among girls in relation to the 4th dose of RTS,S

  Through study completion, an average of 1 year

Study Arms (2)

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)

Other: Case-control study of clinical outcomes

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.

Other: Case-control study of mortality outcome

Interventions

Case-control study of clinical outcomes OTHER

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

Case-control study of clinical outcomes

Case-control study of mortality outcome OTHER

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

Case-control study of mortality outcome

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise children aged 6-59 months who live in RTS,S implementation areas in Ghana, Kenya and Malawi and who were eligible to have received RTS,S based on their date or birth and age

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

Sponsors & Collaborators

• Kintampo Health Research Centre, Ghana: lead
• European Vaccine Initiative: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• African Research Collaboration for Health Limited: collaborator
• Kenya Medical Research Institute: collaborator
• University of Malawi: collaborator
• PATH: collaborator

Study Sites (4)

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

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Kwaku Poku Asante, PhD

  Kintampo Health Research Centre, Ghana

  PRINCIPAL INVESTIGATOR

• Don Mathanga, PhD

  College of Medicine, University of Malawi, Malawi

  PRINCIPAL INVESTIGATOR

• Samuel Akech, PhD

  African Research Collaboration for Health Limited, Kenya

  PRINCIPAL INVESTIGATOR

• Simon Kariuki, PhD

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Gyan

CONTACT

0208398541; thomas.gyan@kintampo-hrc.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 13, 2021
• Study Start: October 18, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

KE (2); GH (1); MA (1)