Strengthening the Evidence for Policy on the RTS,S/AS01 Malaria Vaccine
ConditionMalaria
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-59
SponsorKintampo Health Research Centre, Ghana
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Caregiver not willing to provide consent
Trial 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
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Case-control study of clinical outcomes
Other interventionA case-control questionnaire will be administered at the home of cases and controls
Case-control study of mortality outcome
Other interventionA case-control questionnaire will be administered at the home of cases and controls
Treatment groups
9,280 Participants
are divided into 2 treatment groupsGroup A: Case-control study of clinical outcomes1 intervention
Group B: Case-control study of mortality outcome1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Through study completion, an average of 1 year2
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
Time frame
Through study completion, an average of 1 year3
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.
Time frame
Through study completion, an average of 1 year4
Number of deaths in children by gender
Number of deaths in children stratified by gender in children aged 6-59 months
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Number of children with a diagnosis of severe malaria in relation to the 4th dose of RTS,S
Hospital admissions with malaria which meet WHO criteria for a diagnosis of severe malaria
Time frame
Through study completion, an average of 1 year2
Number of children with a diagnosis of cerebral malaria in relation to the 4th dose of RTS,S
Hospital admissions with malaria which meet WHO criteria for a diagnosis of cerebral malaria
Time frame
Through study completion, an average of 1 year3
Number of deaths of any cause in relation to the 4th dose of RTS,S
Number of deaths of any cause in relation to the 4th dose of RTS,S among children aged 6-59 months.
Time frame
Through study completion, an average of 1 year4
Number of deaths among girls in relation to the 4th dose of RTS,S
Number of deaths in children stratified by gender in relation to the 4th dose of RTS,S among children aged 1-59 months
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kintampo Health Research Centre, Ghana
Lead sponsor
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
Source ClinicalTrials.gov