Seasonal R21 Mass Vaccination for Malaria Elimination
NCT Number: NCT06578572
Acronym: SERVAL
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Malaria
Interventions: BIOLOGICAL: R21Matrix M
Sponsor: London School of Hygiene and Tropical Medicine
Collaborators: National Malaria Control Programme, The Gambia
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 16200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-05-30
Completion Date: 2025-12-31
Locations: Clinical Research Unit of Nanoro, Burkina Faso, Nanoro, Burkina Faso|MRC Unit The Gambia at LSHTM, Fajara, 273, Gambia

Summary:
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.

Primary Outcome Measures: 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., At 6 months ( October - November 2024) post first round of vaccination
Secondary Outcome Measures: 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), 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)., 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), 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., 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)., 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, 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., 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, Up to 4 weeks post the third vaccination round|Coverage of the booster dose, Coverage of the booster dose, 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., Up to 6 months post booster dose