Kwaku Poku Asante1, Daniel Ansong2, Seyram Kaali3, Samuel Adjei2, Marc Lievens4, Lydia Nana Badu2, Prince Agyapong Darko5, Patrick Boakye Yiadom Buabeng2, Owusu Boahen6, Theresa Maria Rettig2, Clara Agutu7, Samuel Benard Ekow Harrison8, Yaw Ntiamoah2, Japhet Adomako Anim9, Elisha Adeniji10, Albert Agordo Dornudo2, Emilia Gvozdenovic11, David Dosoo12, David Sambian2, Harry Owusu-Boateng2, Elvis Ato Wilson13, Frank Prempeh2, Pascale Vandoolaeghe14, Lode Schuerman15, Seth Owusu-Agyei16, Tsiri Agbenyega17, Opokua Ofori-Anyinam18. 1. Kintampo Health Research Center, Ghana Health Service, PO Box 200, Kintampo, Ghana. Electronic address: kwakupoku.asante@kintampo-hrc.org. 2. Kwame Nkrumah University of Science & Technology/Agogo Presbyterian Hospital, P.O. Box 27 Agogo, Asante Akyem, Ghana. 3. Kintampo Health Research Center, Ghana Health Service, PO Box 200, Kintampo, Ghana. Electronic address: kaali.seyram@kintampo-hrc.org. 4. GSK Vaccines, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: marc.lievens@gsk.com. 5. Kintampo Health Research Center, Ghana Health Service, PO Box 200, Kintampo, Ghana. Electronic address: agyapong.darko@kintampo-hrc.org. 6. Kintampo Health Research Center, Ghana Health Service, PO Box 200, Kintampo, Ghana. Electronic address: owusu.boahen@kintampo-hrc.org. 7. GSK Vaccines, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: CAgutu@kemri-wellcome.org. 8. Kintampo Health Research Center, Ghana Health Service, PO Box 200, Kintampo, Ghana. Electronic address: samuel.harrison@kintampo-hrc.org. 9. Kintampo Health Research Center, Ghana Health Service, PO Box 200, Kintampo, Ghana. Electronic address: japhet.anim@kintampo-hrc.org. 10. Kintampo Health Research Center, Ghana Health Service, PO Box 200, Kintampo, Ghana. Electronic address: elisha.adeniji@kintampo-hrc.org. 11. GSK Vaccines, Avenue Fleming 20, 1300 Wavre, Belgium. 12. Kintampo Health Research Center, Ghana Health Service, PO Box 200, Kintampo, Ghana. Electronic address: david.dosoo@kintampo-hrc.org. 13. Kintampo Health Research Center, Ghana Health Service, PO Box 200, Kintampo, Ghana. Electronic address: elvis.wilson@kintampo-hrc.org. 14. GSK Vaccines, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: pascale.vandoolaeghe@gsk.com. 15. GSK Vaccines, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: Lode.Schuerman@gsk.com. 16. Kintampo Health Research Center, Ghana Health Service, PO Box 200, Kintampo, Ghana; London School of Hygiene and Tropical Medicine, UK; University of Health and Allied Sciences, Ho, Ghana. Electronic address: sowusuagyei@uhas.edu.gh. 17. Kwame Nkrumah University of Science & Technology/Agogo Presbyterian Hospital, P.O. Box 27 Agogo, Asante Akyem, Ghana. Electronic address: tsiri@ghana.com. 18. GSK Vaccines, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: opokua.ofori-anyinam@gsk.com.
Abstract
BACKGROUND: To 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. METHODS: In 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. RESULTS: Non-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. CONCLUSIONS: RTS,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.
RCT Entities:
BACKGROUND: To 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. METHODS: In 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. RESULTS: Non-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. CONCLUSIONS:RTS,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.
Authors: Pritik A Shah; Mohammad Mehedi Hasan; Abdul Moiz Sahito; Suyog Y Patel; Sarker Ramproshad; Banani Mondal; Mohammad Yasir Essar Journal: Ann Med Surg (Lond) Date: 2022-06-18