Seasonal Vaccination With the RTS,S/AS01 Malaria Vaccine Given With or Without Seasonal Malaria Chemoprevention: Extension of a Randomised, Double-blind Phase 3 Trial Until Children Reach the Age of Five Years

A double-blind, individual randomised trial will be undertaken in children under five years of age living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine whether administration of further doses of the malaria vaccine RTS,S/AS01 at the beginning of the malaria transmission until children reach the age of five years is (a) as effective as SMC with SP + AQ in preventing clinical malaria (b) provides additional, useful protection when given together with SMC. The primary trial end-point will be the incidence of clinical episodes of malaria detected by passive case detection. This is a two year extension of the current RTS,S/AS01 + SMC trial to continue the trial until the study children reach the age of five years, the current age at which SMC is recommended until.

开始日期2020-04-01

申办/合作机构

London School of Hygiene & Tropical Medicine

NCT03143218 / Completed临床3期IIT

A Phase IIIB Comparative Trial of Seasonal Vaccination With the Malaria Vaccine RTS,S/AS01, Seasonal Malaria Chemoprevention and of the Two Interventions Combined

A double-blind, individual randomised trial will be undertaken in 6000 children under the age of five years living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine whether the malaria vaccine RTS,S/AS01 is (a) as effective as SMC with SP + AQ in preventing clinical malaria (b) provides additional, useful protection when given together with SMC. The primary trial end-point will be the incidence of clinical episodes of malaria detected by passive case detection.

开始日期2017-04-17

申办/合作机构

London School of Hygiene & Tropical Medicine

100 项与 RTSS adjuvanted with AS01(London School of Hygiene and Tropical Medicine) 相关的临床结果

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100 项与 RTSS adjuvanted with AS01(London School of Hygiene and Tropical Medicine) 相关的转化医学

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100 项与 RTSS adjuvanted with AS01(London School of Hygiene and Tropical Medicine) 相关的专利（医药）

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项与 RTSS adjuvanted with AS01(London School of Hygiene and Tropical Medicine) 相关的文献（医药）

Malaria journal

Malaria vaccine coverage estimation using age-eligible populations and service user denominators in Kenya

Article

作者: Jalang'o, Rose ; Snow, Robert W ; Moturi, Angela K ; Okiro, Emelda A ; Muchiri, Samuel K ; Cherono, Anitah

Abstract:

Background:

The World Health Organization approved the RTS,S/AS01 malaria vaccine for wider rollout, and Kenya participated in a phased pilot implementation from 2019 to understand its impact under routine conditions. Vaccine delivery requires coverage measures at national and sub-national levels to evaluate progress over time. This study aimed to estimate the coverage of the RTS,S/AS01 vaccine during the first 36 months of the Kenyan pilot implementation.

Methods:

Monthly dose-specific immunization data for 23 sub-counties were obtained from routine health information systems at the facility level for 2019–2022. Coverage of each RTS,S/AS01 dose was determined using reported doses as a numerator and service-based (Penta 1 and Measles) or population (projected infant populations from WorldPop) as denominators. Descriptive statistics of vaccine delivery, dropout rates and coverage estimates were computed across the 36-month implementation period.

Results:

Over 36 months, 818,648 RTSS/AS01 doses were administered. Facilities managed by the Ministry of Health and faith-based organizations accounted for over 88% of all vaccines delivered. Overall, service-based malaria vaccine coverage was 96%, 87%, 78%, and 39% for doses 1–4 respectively. Using a population-derived denominator for age-eligible children, vaccine coverage was 78%, 68%, 57%, and 24% for doses 1–4, respectively. Of the children that received measles dose 1 vaccines delivered at 9 months (coverage: 95%), 82% received RTSS/AS01 dose 3, only 66% of children who received measles dose 2 at 18 months (coverage: 59%) also received dose 4.

Conclusion:

The implementation programme successfully maintained high levels of coverage for the first three doses of RTSS/AS01 among children defined as EPI service users up to 9 months of age but had much lower coverage within the community with up to 1 in 5 children not receiving the vaccine. Consistent with vaccines delivered over the age of 1 year, coverage of the fourth malaria dose was low. Vaccine uptake, service access and dropout rates for malaria vaccines require constant monitoring and intervention to ensure maximum protection is conferred.

100 项与 RTSS adjuvanted with AS01(London School of Hygiene and Tropical Medicine) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
恶性疟	临床3期	布基纳法索	London School of Hygiene & Tropical Medicine	2017-04-17
恶性疟	临床3期	马里	London School of Hygiene & Tropical Medicine	2017-04-17

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04319380 (RTSS-SMC, CTgov)	临床3期	恶性疟	5,098	SP+AQ (SMC With SP+AQ)	糧衊襯範蓋齋淵餘獵鏇(獵構膚願構願餘壓廠願) = 夢製遞廠鏇窪願襯範簾網夢簾窪夢窪鹹餘觸齋 (鬱鹹構遞壓範膚積糧齋, 願鏇憲壓範餘繭積餘範 ~ 簾夢鏇壓夢襯築鑰鬱獵) 更多	-	2024-09-20
				SMC placebo+RTS,S/AS01 (RTS,S/AS01)	糧衊襯範蓋齋淵餘獵鏇(獵構膚願構願餘壓廠願) = 壓醖範遞構廠夢衊艱遞網夢簾窪夢窪鹹餘觸齋 (鬱鹹構遞壓範膚積糧齋, 醖醖齋顧製簾製願網襯 ~ 積衊艱遞襯繭獵艱觸餘) 更多
NCT03143218 (RTS,S-SMC \| RTSS-SMC, CTgov)	临床3期	恶性疟	5,920	SP+AQ+RABIPUR® (SMC With SP+AQ)	鏇範廠遞範廠艱夢繭鑰(網夢願壓鑰膚襯構築願) = 窪窪繭製鬱構夢衊遞齋齋製願選窪齋淵膚壓廠 (遞簾廠鬱選鑰觸鹽鑰鹽, 遞簾選醖蓋廠衊願壓遞 ~ 構窪鏇餘鹹廠淵齋艱遞) 更多	-	2022-01-28
				SMC placebo+RTS,S/AS01 (RTS,S/AS01)	鏇範廠遞範廠艱夢繭鑰(網夢願壓鑰膚襯構築願) = 餘獵鹹餘襯遞鹽選觸憲齋製願選窪齋淵膚壓廠 (遞簾廠鬱選鑰觸鹽鑰鹽, 壓襯鹹窪蓋齋壓築鏇糧 ~ 夢範膚憲鹹願糧衊選夢) 更多