Seasonal R21 Mass Vaccination for Malaria Elimination
ConditionMalaria
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-99
SponsorLondon School of Hygiene and Tropical Medicine
About this trial
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:
1. To assess the safety and tolerability of R21 through spontaneously reported adverse events. 2. To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following seasonal mass vaccination with R21 (3 monthly doses). 3. To compare in intervention and control clusters the incidence of clinical malaria (all age groups) after seasonal mass vaccination with R21 (3 monthly doses). 4. To compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after one booster dose of R21. 5. To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following one booster dose of R21. 6. To compare in intervention and control clusters the incidence of clinical malaria (all age groups), after one booster dose of R21. 7. To determine the coverage of seasonal mass vaccination with R21 (primary series of three vaccinations and booster) in intervention clusters and related socio-cultural factors 8. To estimate the cost of seasonal mass vaccination with R21 administration. 9. To estimate the cost-effectiveness of seasonal mass vaccination with R21 compared to standard malaria control measures.
The exploratory objective is to determine whether serological markers can detect changes in malaria transmission following mass vaccination with R21.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age≥ 5 months.
Willingness to comply with trial procedures.
Individual written informed consent obtained at the beginning of the study.
Disqualifiers
Pregnancy
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone.
Any history of anaphylaxis in relation to vaccination.
Known chronic illness.
Trial design
Design model
Parallel
Treatments tested in this trial
R21Matrix M
Biological/VaccineA 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.
Treatment groups
16,200 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 vaccinationSecondary outcomes
1
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 vaccination2
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 round3
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 round4
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 doseSponsors and contacts
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London School of Hygiene and Tropical Medicine
Lead sponsor
National Malaria Control Programme, The Gambia
Collaborator
Source ClinicalTrials.gov