Seasonal malaria vaccination: protocol of a phase 3 trial of seasonal vaccination with the RTS,S/AS01E vaccine, seasonal malaria chemoprevention and the combination of vaccination and chemoprevention
Introduction Seasonal malaria chemoprevention (SMC), with sulphadoxine–pyrimethamine plus amodiaquine (SP+AQ) is effective but does not provide complete protection against clinical malaria. The RTS,S/AS01E malaria vaccine provides a high level of protection shortly after vaccination, but this wanes...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e035433.full |
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| author | Ismaila Thera Irene Kuepfer Daniel Chandramohan Alassane Dicko Issaka Zongo Issaka Sagara Matthew Cairns Modibo Diarra Amadou Tapily Djibrilla Issiaka Koualy Sanogo Almahamoudou Mahamar Frederic Sompougdou Serge Yerbanga Paul Milligan Halidou Tinto Opokua Ofori-Anyinam Jean-Bosco Ouedraogo B Greenwood |
| author_facet | Ismaila Thera Irene Kuepfer Daniel Chandramohan Alassane Dicko Issaka Zongo Issaka Sagara Matthew Cairns Modibo Diarra Amadou Tapily Djibrilla Issiaka Koualy Sanogo Almahamoudou Mahamar Frederic Sompougdou Serge Yerbanga Paul Milligan Halidou Tinto Opokua Ofori-Anyinam Jean-Bosco Ouedraogo B Greenwood |
| author_sort | Ismaila Thera |
| collection | DOAJ |
| description | Introduction Seasonal malaria chemoprevention (SMC), with sulphadoxine–pyrimethamine plus amodiaquine (SP+AQ) is effective but does not provide complete protection against clinical malaria. The RTS,S/AS01E malaria vaccine provides a high level of protection shortly after vaccination, but this wanes rapidly. Such a vaccine could be an alternative or additive to SMC. This trial aims to determine whether seasonal vaccination with RTS,S/AS01E vaccine could be an alternative to SMC and whether a combination of the two interventions would provide added benefits.Methods and analysis This is an individually randomised, double-blind, placebo-controlled trial. 5920 children aged 5–17 months were enrolled in April 2017 in Mali and Burkina Faso. Children in group 1 received three priming doses of RTS,S/AS01E vaccine before the start of the 2017 malaria transmission season and a booster dose at the beginning of two subsequent transmission seasons. In addition, they received SMC SP+AQ placebo on four occasions each year. Children in group 2 received three doses of rabies vaccine in year 1 and hepatitis A vaccine in years 2 and 3 together with four cycles of SMC SP+AQ each year. Children in group 3 received RTS,S/AS01E vaccine and four courses of SMC SP+AQ. Incidence of clinical malaria is determined by case detection at health facilities. Weekly active surveillance for malaria is undertaken in a randomly selected subset of children. The prevalence of malaria is measured in surveys at the end of each transmission season. The primary endpoint is the incidence of clinical malaria confirmed by a positive blood film with a minimum parasite density of 5000 /µL. Primary analysis will be by modified intention to treat defined as children who have received the first dose of the malaria or control vaccine.Ethics and dissemination The protocol was approved by the national ethics committees of Mali and Burkina Faso and the London School of Hygiene and Tropical Medicine. The results will be presented to all stakeholders and published in open access journals.Trial registration number NCT03143218; Pre-results |
| first_indexed | 2024-12-17T01:36:19Z |
| format | Article |
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| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-12-17T01:36:19Z |
| publishDate | 2020-09-01 |
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| spelling | doaj.art-23d4ca4eb7194d2ab2adf24bca83e1ba2022-12-21T22:08:26ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-035433Seasonal malaria vaccination: protocol of a phase 3 trial of seasonal vaccination with the RTS,S/AS01E vaccine, seasonal malaria chemoprevention and the combination of vaccination and chemopreventionIsmaila Thera0Irene Kuepfer1Daniel Chandramohan2Alassane Dicko3Issaka Zongo4Issaka Sagara5Matthew Cairns6Modibo Diarra7Amadou Tapily8Djibrilla Issiaka9Koualy Sanogo10Almahamoudou Mahamar11Frederic Sompougdou12Serge Yerbanga13Paul Milligan14Halidou Tinto15Opokua Ofori-Anyinam16Jean-Bosco Ouedraogo17B Greenwood18Malaria Research and Training Center, Bamako, MaliDepartment of Disease Control, London School of Hygiene & Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UKDepartment of Disease Control, London School of Hygiene and Tropical Medicine, London, UKMalaria Research and Training Center, Bamako, MaliInstitut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina FasoMalaria Research and Training Center, Bamako, MaliDepartment of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UKMalaria Research and Training Center, Bamako, MaliMalaria Research and Training Center, Bamako, MaliMalaria Research and Training Center, Bamako, MaliMalaria Research and Training Center, Bamako, MaliMalaria Research and Training Center, Bamako, MaliInstitut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina FasoInstitut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina FasoDepartment of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UKInstitut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina FasoGlaxoSmithKline Biologicals SA, Wavre, BelgiumInstitut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina FasoDepartment of Disease Control, London School of Hygiene and Tropical Medicine, London, UKIntroduction Seasonal malaria chemoprevention (SMC), with sulphadoxine–pyrimethamine plus amodiaquine (SP+AQ) is effective but does not provide complete protection against clinical malaria. The RTS,S/AS01E malaria vaccine provides a high level of protection shortly after vaccination, but this wanes rapidly. Such a vaccine could be an alternative or additive to SMC. This trial aims to determine whether seasonal vaccination with RTS,S/AS01E vaccine could be an alternative to SMC and whether a combination of the two interventions would provide added benefits.Methods and analysis This is an individually randomised, double-blind, placebo-controlled trial. 5920 children aged 5–17 months were enrolled in April 2017 in Mali and Burkina Faso. Children in group 1 received three priming doses of RTS,S/AS01E vaccine before the start of the 2017 malaria transmission season and a booster dose at the beginning of two subsequent transmission seasons. In addition, they received SMC SP+AQ placebo on four occasions each year. Children in group 2 received three doses of rabies vaccine in year 1 and hepatitis A vaccine in years 2 and 3 together with four cycles of SMC SP+AQ each year. Children in group 3 received RTS,S/AS01E vaccine and four courses of SMC SP+AQ. Incidence of clinical malaria is determined by case detection at health facilities. Weekly active surveillance for malaria is undertaken in a randomly selected subset of children. The prevalence of malaria is measured in surveys at the end of each transmission season. The primary endpoint is the incidence of clinical malaria confirmed by a positive blood film with a minimum parasite density of 5000 /µL. Primary analysis will be by modified intention to treat defined as children who have received the first dose of the malaria or control vaccine.Ethics and dissemination The protocol was approved by the national ethics committees of Mali and Burkina Faso and the London School of Hygiene and Tropical Medicine. The results will be presented to all stakeholders and published in open access journals.Trial registration number NCT03143218; Pre-resultshttps://bmjopen.bmj.com/content/10/9/e035433.full |
| spellingShingle | Ismaila Thera Irene Kuepfer Daniel Chandramohan Alassane Dicko Issaka Zongo Issaka Sagara Matthew Cairns Modibo Diarra Amadou Tapily Djibrilla Issiaka Koualy Sanogo Almahamoudou Mahamar Frederic Sompougdou Serge Yerbanga Paul Milligan Halidou Tinto Opokua Ofori-Anyinam Jean-Bosco Ouedraogo B Greenwood Seasonal malaria vaccination: protocol of a phase 3 trial of seasonal vaccination with the RTS,S/AS01E vaccine, seasonal malaria chemoprevention and the combination of vaccination and chemoprevention BMJ Open |
| title | Seasonal malaria vaccination: protocol of a phase 3 trial of seasonal vaccination with the RTS,S/AS01E vaccine, seasonal malaria chemoprevention and the combination of vaccination and chemoprevention |
| title_full | Seasonal malaria vaccination: protocol of a phase 3 trial of seasonal vaccination with the RTS,S/AS01E vaccine, seasonal malaria chemoprevention and the combination of vaccination and chemoprevention |
| title_fullStr | Seasonal malaria vaccination: protocol of a phase 3 trial of seasonal vaccination with the RTS,S/AS01E vaccine, seasonal malaria chemoprevention and the combination of vaccination and chemoprevention |
| title_full_unstemmed | Seasonal malaria vaccination: protocol of a phase 3 trial of seasonal vaccination with the RTS,S/AS01E vaccine, seasonal malaria chemoprevention and the combination of vaccination and chemoprevention |
| title_short | Seasonal malaria vaccination: protocol of a phase 3 trial of seasonal vaccination with the RTS,S/AS01E vaccine, seasonal malaria chemoprevention and the combination of vaccination and chemoprevention |
| title_sort | seasonal malaria vaccination protocol of a phase 3 trial of seasonal vaccination with the rts s as01e vaccine seasonal malaria chemoprevention and the combination of vaccination and chemoprevention |
| url | https://bmjopen.bmj.com/content/10/9/e035433.full |
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