Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2023-02-22
Brief Title:
The Impact RTSSAS01 Vaccine in School Aged Children RTSSAS01 Malaria Vaccine in School Aged Children
Sponsor:
Kamuzu University of Health Sciences
Organization:
Kamuzu University of Health Sciences
Study Overview
Official Title:
The Impact Feasibility Acceptability and Cost Effectiveness of the RTSSAS01 Malaria Vaccine in School Aged Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Across sub-Saharan Africa school-age children bear an under-appreciated burden of malaria An estimated 200 million school-age children are at risk of malaria and in many areas prevalence of infection exceeds 50 The high infection rates in this group serves as a source of onward parasite transmission undermining elimination and control efforts Furthermore malaria illness and malaria-induced anemia in this age group lead to school absenteeism and impaired cognitive function and classroom attention ultimately resulting in reduced academic achievement Although universal malaria interventions such as insecticide treated nets ITNs and access to prompt diagnosis and treatment are available to school-age children this age group is the least likely to benefit from these interventions Furthermore efficacy of these approaches may be compromised by increasing anti-malarial drug and insecticide resistance A malaria vaccine could help to avert the burden of malaria in this age group
The RTSSAS01 malaria vaccine has recently been recommended for vaccination of young children 24 months by the World health organization WHO after a Phase 3 trial and an implementation trial showed that the vaccine had moderate but significant efficacy to prevent clinical and severe malaria in young children Previous randomized trials suggest that the vaccine is safe for older children However efficacy of the vaccine has never been assessed in school age children Kamuzu University of Health Sciences in partnership with the Malawian Ministry of Health seeks to evaluate the efficacy of the newly introduced RTSSAS01 malaria vaccine in school aged children The study hypothesizes that vaccination will decrease the morbidity and transmission of malaria as well as improve school absenteeism and educational outcomes
The RTSSAS01 malaria vaccine has recently been recommended for vaccination of young children 24 months by the World health organization WHO after a Phase 3 trial and an implementation trial showed that the vaccine had moderate but significant efficacy to prevent clinical and severe malaria in young children Previous randomized trials suggest that the vaccine is safe for older children However efficacy of the vaccine has never been assessed in school age children Kamuzu University of Health Sciences in partnership with the Malawian Ministry of Health seeks to evaluate the efficacy of the newly introduced RTSSAS01 malaria vaccine in school aged children The study hypothesizes that vaccination will decrease the morbidity and transmission of malaria as well as improve school absenteeism and educational outcomes
Detailed Description:
This study will be an individual randomized open-label clinical trial to assess the impact feasibility acceptability and cost effectiveness of the RTSSAS01 vaccine in school-aged children in a malaria endemic environment
A total of 5400 children aged 6 to 15 years who are attending standards 1-8 in five schools in rural Machinga district of Malawi will be randomized to one of the four intervention arms RTSSAS01 vaccine only RTSS-only RTSSAS01 vaccine plus an effective antimalarial artemether-lumefantrine at the start of the study RTSSAL artemether-lumefantrine only AL-only and a control group that receives only Vitamin A at the start of the study VIT-A After obtaining consent from guardians and assent from children older than 13 years of age participating children will be randomly allocated in a 1111 ratio into the intervention arms Randomization will be stratified by classroom and school Additionally two siblings of a subset of 1000 children receiving the vaccine will be enrolled to evaluate the indirect effect of vaccination
All children will be followed for up to 12 months after vaccination Clinical malaria will be ascertained through passive case detection PCD and attendance and education outcomes will be ascertained through school records PCD will conducted using the Learner Treatment Kit program platform a school-based malaria diagnosis and treatment program that the Ministry of Health and Education are currently supporting across the selected schools Through PCD the safety of the interventions will also be monitored
In a subset of 1000 enrolled in the study 250 per intervention arm and two of their siblings will also be followed in three pre-scheduled visits the active case detection ACD cohort in which the investigators will evaluate outcomes including the direct effect of the vaccine on malaria subclinical infection and the indirect effect of the vaccine Children will be selected for this cohort randomly stratifying the samples by school and four age strata 6-7 years 8-9 years 10-12 years 13-15 years Participants will be invited to visit a health center at baseline ie before the interventions are administered one month six months and 12 months after the end of the primary regimen of RTSSAS01 At each of these visits capillary blood 500 µl will be collected through finger pricks for a dry blood spot from which malaria quantitative polymerase chain reactions qPCRs will be performed to detect asexual parasites In addition one drop of blood will be used to measure hemoglobin concentrations The remaining blood will be stored In 500 children enrolled in the ACD cohort and receiving vaccination 6 mL of venous blood will be collected to evaluate immunological outcomes These children will be randomly selected among those receiving RTS SAS01 200 RTSSAL and 200 RTSS-only in four schools 50 X 2 intervention groups in each school and the 4 age strata 12 per age strata in each school and intervention group
Feasibility acceptability and cost data will be collected through interviews with all study stakeholders learners parents teachers community leaders and district and national policy makers
A total of 5400 children aged 6 to 15 years who are attending standards 1-8 in five schools in rural Machinga district of Malawi will be randomized to one of the four intervention arms RTSSAS01 vaccine only RTSS-only RTSSAS01 vaccine plus an effective antimalarial artemether-lumefantrine at the start of the study RTSSAL artemether-lumefantrine only AL-only and a control group that receives only Vitamin A at the start of the study VIT-A After obtaining consent from guardians and assent from children older than 13 years of age participating children will be randomly allocated in a 1111 ratio into the intervention arms Randomization will be stratified by classroom and school Additionally two siblings of a subset of 1000 children receiving the vaccine will be enrolled to evaluate the indirect effect of vaccination
All children will be followed for up to 12 months after vaccination Clinical malaria will be ascertained through passive case detection PCD and attendance and education outcomes will be ascertained through school records PCD will conducted using the Learner Treatment Kit program platform a school-based malaria diagnosis and treatment program that the Ministry of Health and Education are currently supporting across the selected schools Through PCD the safety of the interventions will also be monitored
In a subset of 1000 enrolled in the study 250 per intervention arm and two of their siblings will also be followed in three pre-scheduled visits the active case detection ACD cohort in which the investigators will evaluate outcomes including the direct effect of the vaccine on malaria subclinical infection and the indirect effect of the vaccine Children will be selected for this cohort randomly stratifying the samples by school and four age strata 6-7 years 8-9 years 10-12 years 13-15 years Participants will be invited to visit a health center at baseline ie before the interventions are administered one month six months and 12 months after the end of the primary regimen of RTSSAS01 At each of these visits capillary blood 500 µl will be collected through finger pricks for a dry blood spot from which malaria quantitative polymerase chain reactions qPCRs will be performed to detect asexual parasites In addition one drop of blood will be used to measure hemoglobin concentrations The remaining blood will be stored In 500 children enrolled in the ACD cohort and receiving vaccination 6 mL of venous blood will be collected to evaluate immunological outcomes These children will be randomly selected among those receiving RTS SAS01 200 RTSSAL and 200 RTSS-only in four schools 50 X 2 intervention groups in each school and the 4 age strata 12 per age strata in each school and intervention group
Feasibility acceptability and cost data will be collected through interviews with all study stakeholders learners parents teachers community leaders and district and national policy makers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None