Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578572
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-27
Brief Title:
Seasonal R21 Mass Vaccination for Malaria Elimination
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Seasonal R21 Mass Vaccination for Malaria Elimination
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SERVAL
Brief Summary:
This is a cluster randomized trial to determine the impact of seasonal R21MM 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
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
Detailed Description:
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 Therefore15 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 eg 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 ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None