Immunogenicity and safety of the RTS,S/AS01 malaria vaccine co-administered with measles,rubella and yellow fever vaccines in Ghanaian children: A phase IIIb,multi-center,non-inferiority,randomized, open,controlled trial |
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| Affiliation: | 1. Kintampo Health Research Center, Ghana Health Service, PO Box 200, Kintampo, Ghana;2. Kwame Nkrumah University of Science & Technology/Agogo Presbyterian Hospital, P.O. Box 27 Agogo, Asante Akyem, Ghana;3. GSK Vaccines, Avenue Fleming 20, 1300 Wavre, Belgium;4. London School of Hygiene and Tropical Medicine, UK;5. University of Health and Allied Sciences, Ho, Ghana;1. Department of Global Health Studies, Northwestern University, Evanston, IL 60201, United States;2. Department of Anthropology, Northwestern University, Evanston, IL 60201, United States;3. Kenya Medical Research Institute, Nairobi, Kenya;1. Bandim Health Project, INDEPTH Network, Apartado 861, Bissau, Guinea-Bissau;2. Research Center for Vitamins and Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark;1. Research Center for Vitamins and Vaccines (CVIVA), Bandim Health Project, Artillerivej 5, 2300 Copenhagen S, Denmark;2. Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau;3. The London School of Hygiene and Tropical Medicine, Keppel Street, London, UK;4. OPEN, Institute of Clinical Research, University of Southern Denmark/Odense University Hospital, Denmark;1. Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA;2. Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA;3. University of North Carolina, Chapel Hill, NC 27599, USA;4. University of North Carolina Project, Lilongwe, Malawi;5. Division of Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, NC 27599, USA;6. Department of Pathology and Laboratory Medicine, Brown University, Providence, RI 02903, USA;1. Faculty of Health Sciences, University of Southern Denmark, Denmark;2. Research Center for Vitamins and Vaccines (CVIVA), Statens Serum Institute, Denmark;3. Department of Clinical Microbiology, Copenhagen University Hospital Hvidovre, Denmark;4. Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau;5. OPEN, Institute for Clinical Research, University of Southern Denmark and Odense University Hospital, Denmark |
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| Abstract: | BackgroundTo optimize vaccine implementation visits for young children, it could be efficient to administer the first RTS,S/AS01 malaria vaccine dose during the Expanded Programme on Immunization (EPI) visit at 6 months of age together with Vitamin A supplementation and the third RTS,S/AS01 dose on the same day as yellow fever (YF), measles and rubella vaccines at 9 months of age. We evaluated the safety and immunogenicity of RTS,S/AS01 when co-administered with YF and combined measles-rubella (MR) vaccines.MethodsIn this phase 3b, open-label, controlled study (NCT02699099), 709 Ghanaian children were randomized (1:1:1) to receive RTS,S/AS01 at 6, 7.5 and 9 months of age, and YF and MR vaccines at 9 or 10.5 months of age (RTS,S coad and RTS,S alone groups, respectively). The third group received YF and MR vaccines at 9 months of age and will receive RTS,S/AS01 at 10.5, 11.5 and 12.5 months of age (Control group). All children received Vitamin A at 6 months of age. Non-inferiority of immune responses to the vaccine antigens was evaluated 1 month following co-administration versus RTS,S/AS01 or EPI vaccines (YF and MR vaccines) alone using pre-defined non-inferiority criteria. Safety was assessed until Study month 4.5.ResultsNon-inferiority of antibody responses to the anti-circumsporozoite and anti-hepatitis B virus surface antigens when RTS,S/AS01 was co-administered with YF and MR vaccines versus RTS,S/AS01 alone was demonstrated. Non-inferiority of antibody responses to the measles, rubella, and YF antigens when RTS,S/AS01 was co-administered with YF and MR vaccines versus YF and MR vaccines alone was demonstrated. The safety profile of all vaccines was clinically acceptable in all groups.ConclusionsRTS,S/AS01 can be co-administered with Vitamin A at 6 months and with YF and MR vaccines at 9 months of age during EPI visits, without immune response impairment to any vaccine antigen or negative safety effect. |
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