A Phase 3 interventional study of R21Matrix M in Malaria, sponsored by London School of Hygiene and Tropical Medicine. Recruiting at 2 sites in 2 countries. Open to participants aged 5 Months to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 3, Interventional, and Prevention
This is a cluster randomized trial to determine the impact of seasonal R21/MM mass vaccination (all ages) on malaria transmission and morbidity. Fifty-four villages (30 in The Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21 or no mass vaccination.
The primary objective is to compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after seasonal mass vaccination with R21 (3 monthly doses).
Secondary objectives are:
The exploratory objective is to determine whether serological markers can detect changes in malaria transmission following mass vaccination with R21.
This is a cluster-randomized controlled trial. Fifty-four villages (30 in The Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21 or no mass vaccination. Therefore,15 medium-sized (200-600 people) villages in The Gambia and 12 medium-sized (200-600 people) villages in Burkina Faso will receive the intervention. All study villages will receive standard control intervention, e.g., seasonal malaria chemoprevention, insecticide-treated bed nets, implemented by the National Malaria Control Program and according the National Strategic Plan for malaria control. Mass vaccination will be completed before the start of the malaria transmission season, i.e. July.
A cross-sectional survey to estimate malaria prevalence will be implemented at peak transmission, both following the mass vaccination with 3 doses (first year) and the booster dose (second year). A blood sample will be collected during the malaria transmission season from a cohort of randomly selected individuals to determine the incidence of malaria infection. A system of passive case detection to determine the incidence of clinical malaria will be set up throughout the study period, with special attention to the malaria transmission season (July-December).
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 16,200 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Three monthly doses of R21/MM will be administered to all eligible residents in the 27 intervention villages (15 in The Gambia and 12 in Burkina Faso), starting from May 2024, with the aim of having completed the vaccination schedule by end of July 2024, before the malaria transmission season starts. A booster vaccine dose will be administered in June 2025 to all eligible individuals who received at least one vaccine dose the previous year. Residents who are eligible but not vaccinated in the previous year, will be offered a complete vaccination schedule, i.e. 3 monthly doses, starting from April. After each vaccination, the first 100 vaccinated individuals will be visited at home daily, for 3 consecutive days, and then at day 7 after the vaccination to collect local and systemic adverse events (AE). Vaccinated individuals (or their parents) will be asked to report to the nurse based in their study village any illness occurring during the 28 days after vaccination.
Biological: R21Matrix M
Only standard malaria control measures ( Malaria Chemoprevention (SMC), Intermittent Preventive Treatment during pregnancy (IPTp), Insecticide-Treated bed Nets (ITN), prompt diagnosis and treatment of patients with uncomplicated malaria and Indoor Residual Spraying (IRS)) will be implemented in control villages.
A mixture of R21/Matrix M at a dose of 5 μg (for children up to 14 years of age) or 10 μg ( for individuals ≥ 15 years old) with 50 μg of Matrix-M will be administered monthly over 3 months (one dose per month over 3 months (May, June, and July 2024) plus a booster dose in June 2025.
Prevalence of malaria infection by PCR in all age groups at peak transmission season (October-November) following the first vaccination with 3 doses.
A cross-sectional survey will be conducted at peak transmission in October -November 2024 to determine prevalence of malaria infection.
Time frame: At 6 months ( October - November 2024) post first round of vaccination
Occurrence of Adverse Events (AEs) during follow up.
1. Occurrence of solicited local and/or systemic reactogenicity 2. Occurrence of unsolicited adverse events 3. Occurrence of abnormal hematology and biochemistry parameters ( clinically significant values) 4. Occurrence of serious adverse events ( throughout the trial)
Time frame: Up to 28 days post vaccination
Incidence of malaria infection in all age groups during the transmission season following mass vaccination with R21
Incidence of malaria infection will be determined by molecular analyses (PCR) in a cohort of 20 individuals per village in Burkina Faso and 30 individuals per villages in The Gambia through monthly home visits ( following mass vaccination with R21).
Time frame: Up to 6 months post the third vaccination round
Incidence of clinical malaria in all age groups following mass vaccination with R21.
A passive case detection of clinical malaria throughout the study period, with special attention to the malaria transmission season (July-December)
Time frame: Up to 6 months post the third vaccination round
Prevalence of malaria infection by PCR in all age groups at peak transmission following the booster dose.
A cross-sectional survey will be conducted at peak transmission in October -November 2025 to determine prevalence of malaria infection.
Time frame: At 6 months ( October - November 2025) post booster dose
Incidence of malaria infection in all age groups during the transmission season following the booster dose.
Incidence of malaria infection will be determined by molecular analyses (PCR) in a cohort of 20 individuals per village in Burkina Faso and 30 individuals per villages in The Gambia through monthly home visits ( following the booster dose).
Time frame: Up to 6 months post booster dose
Incidence of clinical malaria in all age groups following the booster dose.
Passive detection of clinical malaria both at the community and at health facility level
Time frame: Up to 6 months post the third vaccination round
Coverage of completed vaccination schedule (3 doses) during the mass vaccination with 3 doses.
Coverage of completed vaccination schedule (3 doses) during the mass vaccination with 3 doses.
Time frame: Up to 4 weeks post the third vaccination round
Coverage of at least one vaccine dose administered during the mass vaccination with 3 doses
Coverage of at least one vaccine dose
Time frame: Up to 4 weeks post the third vaccination round
Coverage of the booster dose
Coverage of the booster dose
Time frame: Up to 4 weeks post booster dose
Cost of vaccine administration and cost effectiveness, both for the mass vaccination campaign with 3 doses and the booster dose.
A cross sectional survey will be carried out at the beginning of the project in both study arms to estimate the cost of seeking care among households and the costs supported by the health facility. Cost of mass vaccination will be collected for each round.
Time frame: Up to 6 months post booster dose
Plan to share: Yes — Anonymised IPD data will be made available from one month after trial publication and for a further 24 months
Supporting information: Study protocol, Informed consent form
Time frame: 1 month after the publication date and for a further 24 months
Access criteria: Application to the principal investigator with a justification of the request
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Dec 2024, 7 months after the start.
Of 44 non-industry phase 3 interventional studies under Malaria, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 34. This study's planned 7 months is below that.
Counting every sponsor, half of 50 studies reached it within 23 months; a quarter within 17 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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