MalariaMVPE-CCNCT05041556
Strengthening the Evidence for Policy on the RTS,S/AS01 Malaria Vaccine
An observational study of Malaria, run by Kintampo Health Research Centre, Ghana at 4 sites in 3 countries.
Trial 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). Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- Caregiver not willing to provide consent
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Kenya2 sites, 2 recruiting
- Recruiting
African Research Collaboration for Health Limited
Nairobi
Samuel Akech Akech, PhD
- Recruiting
Kenya Medical Research Institute (KEMRI)
Nairobi
Simon Kariuki, PhD
Ghana1 site, 1 recruiting
- Recruiting
Kintampo Health Research Centre
Kintampo
Kwaku Poku Asante, PhD
Malawi1 site, 1 recruiting
- Recruiting
College of Medicine, University of Malawi
Blantyre
Don Mathanga, PhD
About this study
Official title: 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
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:
- Safety among children who received the malaria vaccine, with focus on cerebral malaria, meningitis and severe malaria
- The impact of the malaria vaccine on all-cause mortality for boys and girls, AND
- Promote use of case-control approaches by Expanded Programmes on Immunization (EPI) and malaria control programmes.
Read the detailed description
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 (MVPE). This project will support the embedding of case-control studies into the ongoing evaluation component of the RTS,S malaria vaccine pilot implementation programme (MVIP) in Ghana, Kenya, and Malawi. The evaluation data are being collected through a series of household surveys, and sentinel hospital and community mortality surveillance build on routine systems.
The case-control studies will run for a period of 45 months in the three countries (Ghana, Kenya, Malawi). The primary objectives of the case-control studies focus on safety, impact and capacity building. There will be no defined number of cases per country. Data for the case-control studies will be collected using two-pronged approach.
CASE-CONTROL STUDY OF CLINICAL OUTCOMES.
For each case, 4 controls will be recruited.
Children living in the study area of the ongoing MVPE and recruited from the catchment areas of the sentinel hospital of the MVPE will be recruited. Children aged 6 months - 59 months will be recruited into the study. All eligible cases identified from the MVPE sentinel hospital surveillance systems will be recruited. Data needed on cases already being collected as part of the MVPE sentinel surveillance will be updated following consent. Eligible cases will be approached for consent for the case-control component and to ascertain their residence and collect additional data. Neighbourhood controls will be recruited by canvassing homes in a predetermined pattern from the case's home until four eligible controls are identified and interviewed. Research officers will identify and consent controls. Similar information will be collected as for the cases. A total of 46 meningitis cases and 184 controls, and 930 severe malaria cases and 3720 controls will contribute to the clinical case-control endpoints across the three countries. This is expected to provide 90% power to detect a 10 to 5-fold increase in incidence of meningitis in vaccine recipients. The updated power calculations indicate about 600 severe malaria cases is needed to detect the 40% benefit that was seen in the phase 3 trial. And 330 severe malaria cases eligible to have received 3 doses (and not yet eligible for dose 4) are needed for 80% power to detect a 30% reduction in incidence. A total of 180 cases of cerebral malaria and 720 controls are expected to be recruited to provide 90% power to detect a 2-fold increase in incidence of cerebral malaria in children who received 3 doses of RTSS/AS01
CASE-CONTROL STUDY OF MORTALITY OUTCOMES.
For each case, 4 controls will be recruited.
As part of the MVPE, data is already captured on all children aged 1 - 59 months who live in an MVIP area and die by verbal autopsy teams at the child's home. Data already collected within the context of the MVPE will be merged to the case-control dataset using the child's unique identifier, rather than duplicated. For the mortality case-control outcomes, verbal autopsy teams will identify eligible deaths at the time of the verbal autopsy. Written, or witnessed and thumb-printed, informed consent will be obtained from each child's carer before data are included in the case-control dataset. Data may be captured retrospectively once the informed consent form is signed or thumb-printed.
Four controls will be selected per case, and matched based on their location and their age (within 30 days of the case's date of birth). To avoid selection bias, research officers will canvass up to several homes in a predetermined pattern from the case's home until four controls are identified and interviewed. All eligible controls will be approached for consent. The same information will be collected for controls as for the cases. A total of 1000 mortality cases and 4000 controls will contribute to the clinical case-control endpoints. This is expected to provide 90% power to detect a 2-fold difference between girls and boys.
- Conditions
- Malaria
- Being tested
- Case-control study of clinical outcomes, Case-control study of mortality outcome
- Keywords
- Malaria, Vaccines, Case-control, Safety, Mortality
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case-control study of clinical outcomesOther
A case-control questionnaire will be administered at the home of cases and controls
Case-control study of mortality outcomeOther
A case-control questionnaire will be administered at the home of cases and controls
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Other: Case-control study of mortality outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Hospital admissions with malaria which meet WHO criteria for a diagnosis of severe malaria
Measured: 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
Hospital admissions with malaria which meet WHO criteria for a diagnosis of cerebral malaria
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start18 Oct 2021
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 9,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kintampo Health Research Centre, Ghana
- Sponsor type
- University, hospital or other
- Collaborators
- European Vaccine Initiative, London School of Hygiene and Tropical Medicine, African Research Collaboration for Health Limited, Kenya Medical Research Institute, University of Malawi, PATH
- Responsible party
- Sponsor
- Investigators
- Kwaku Poku Asante, PhD, Principal investigator, Kintampo Health Research Centre, GhanaDon Mathanga, PhD, Principal investigator, College of Medicine, University of Malawi, MalawiSamuel Akech, PhD, Principal investigator, African Research Collaboration for Health Limited, KenyaSimon Kariuki, PhD, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041556
- Sponsor's protocol ID
- GHS-ERC 006/01/21
- Acronym
- MVPE-CC
- Status last verified
- Feb 2025
- First submitted
- 20 Aug 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05041556
- Acronym / sponsor ID
- MVPE-CC / GHS-ERC 006/01/21
- Conditions
- Malaria
- Keywords
- Malaria, Vaccines, Case-control, Safety, Mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,280 participants (estimated)
- Lead sponsor
- Kintampo Health Research Centre, GhanaUniversity, hospital or other
- Collaborators
- European Vaccine Initiative, London School of Hygiene and Tropical Medicine, African Research Collaboration for Health Limited, Kenya Medical Research Institute, University of Malawi, PATH
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Safety among children who received the malaria vaccine, with focus on cerebral malaria, meningitis and severe malaria
- The impact of the malaria vaccine on all-cause mortality for boys and girls, AND
- Promote use of case-control approaches by Expanded Programmes on Immunization (EPI) and malaria control programmes.
Detailed description
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 (MVPE). This project will support the embedding of case-control studies into the ongoing evaluation component of the RTS,S malaria vaccine pilot implementation programme (MVIP) in Ghana, Kenya, and Malawi. The evaluation data are being collected through a series of household surveys, and sentinel hospital and community mortality surveillance build on routine systems.
The case-control studies will run for a period of 45 months in the three countries (Ghana, Kenya, Malawi). The primary objectives of the case-control studies focus on safety, impact and capacity building. There will be no defined number of cases per country. Data for the case-control studies will be collected using two-pronged approach.
CASE-CONTROL STUDY OF CLINICAL OUTCOMES.
For each case, 4 controls will be recruited.
Children living in the study area of the ongoing MVPE and recruited from the catchment areas of the sentinel hospital of the MVPE will be recruited. Children aged 6 months - 59 months will be recruited into the study. All eligible cases identified from the MVPE sentinel hospital surveillance systems will be recruited. Data needed on cases already being collected as part of the MVPE sentinel surveillance will be updated following consent. Eligible cases will be approached for consent for the case-control component and to ascertain their residence and collect additional data. Neighbourhood controls will be recruited by canvassing homes in a predetermined pattern from the case's home until four eligible controls are identified and interviewed. Research officers will identify and consent controls. Similar information will be collected as for the cases. A total of 46 meningitis cases and 184 controls, and 930 severe malaria cases and 3720 controls will contribute to the clinical case-control endpoints across the three countries. This is expected to provide 90% power to detect a 10 to 5-fold increase in incidence of meningitis in vaccine recipients. The updated power calculations indicate about 600 severe malaria cases is needed to detect the 40% benefit that was seen in the phase 3 trial. And 330 severe malaria cases eligible to have received 3 doses (and not yet eligible for dose 4) are needed for 80% power to detect a 30% reduction in incidence. A total of 180 cases of cerebral malaria and 720 controls are expected to be recruited to provide 90% power to detect a 2-fold increase in incidence of cerebral malaria in children who received 3 doses of RTSS/AS01
CASE-CONTROL STUDY OF MORTALITY OUTCOMES.
For each case, 4 controls will be recruited.
As part of the MVPE, data is already captured on all children aged 1 - 59 months who live in an MVIP area and die by verbal autopsy teams at the child's home. Data already collected within the context of the MVPE will be merged to the case-control dataset using the child's unique identifier, rather than duplicated. For the mortality case-control outcomes, verbal autopsy teams will identify eligible deaths at the time of the verbal autopsy. Written, or witnessed and thumb-printed, informed consent will be obtained from each child's carer before data are included in the case-control dataset. Data may be captured retrospectively once the informed consent form is signed or thumb-printed.
Four controls will be selected per case, and matched based on their location and their age (within 30 days of the case's date of birth). To avoid selection bias, research officers will canvass up to several homes in a predetermined pattern from the case's home until four controls are identified and interviewed. All eligible controls will be approached for consent. The same information will be collected for controls as for the cases. A total of 1000 mortality cases and 4000 controls will contribute to the clinical case-control endpoints. This is expected to provide 90% power to detect a 2-fold difference between girls and boys.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case-control study of clinical outcomes | – | Other: Case-control study of clinical outcomesThese 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 | – | Other: Case-control study of mortality outcomeThese 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. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Caregiver not willing to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case-control study of clinical outcomesA case-control questionnaire will be administered at the home of cases and controls | Other | Case-control study of clinical outcomes |
| Case-control study of mortality outcomeA case-control questionnaire will be administered at the home of cases and controls | Other | Case-control study of mortality outcome |
Primary outcome
Number of children admitted with a diagnosis of probable and confirmed meningitis
Time frame: Through study completion, an average of 1 year
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
Number of children admitted with a diagnosis of severe malaria
Time frame: Through study completion, an average of 1 year
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
The number of deaths of any cause
Time frame: Through study completion, an average of 1 year
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.
Number of deaths in children by gender
Time frame: Through study completion, an average of 1 year
Number of deaths in children stratified by gender in children aged 6-59 months
4 secondary outcomes
Number of children with a diagnosis of severe malaria in relation to the 4th dose of RTS,S
Time frame: 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
Time frame: Through study completion, an average of 1 year
Number of deaths of any cause in relation to the 4th dose of RTS,S
Time frame: Through study completion, an average of 1 year
Number of deaths among girls in relation to the 4th dose of RTS,S
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kwaku Poku Asante, PhD principal investigator
Kintampo Health Research Centre, Ghana
Don Mathanga, PhD principal investigator
College of Medicine, University of Malawi, Malawi
Samuel Akech, PhD principal investigator
African Research Collaboration for Health Limited, Kenya
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Kintampo Health Research Centre, Ghana at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Kenya, Ghana, Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Gyan (0208398541, thomas.gyan@kintampo-hrc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children admitted with a diagnosis of probable and confirmed meningitis (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.