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
| Autor: | Tsiri Agbenyega, Seyram Kaali, Elisha Adeniji, Daniel Ansong, Japhet Adomako Anim, Samuel Adjei, Clara Agutu, Pascale Vandoolaeghe, Harry Owusu-Boateng, Emilia Gvozdenovic, Patrick Boakye Yiadom Buabeng, Frank Prempeh, David Sambian, Kwaku Poku Asante, Opokua Ofori-Anyinam, Samuel Benard Ekow Harrison, Theresa Rettig, Albert Agordo Dornudo, Yaw Ntiamoah, David Dosoo, Elvis Ato Wilson, Lode Schuerman, Marc Lievens, Prince Agyapong Darko, Seth Owusu-Agyei, Lydia Nana Badu, Owusu Boahen |
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| Rok vydání: | 2020 |
| Předmět: |
Pediatrics
medicine.medical_specialty 030231 tropical medicine Ghana behavioral disciplines and activities Rubella Measles Article 03 medical and health sciences 0302 clinical medicine Antigen Malaria Vaccines parasitic diseases medicine Humans 030212 general & internal medicine Child General Veterinary General Immunology and Microbiology business.industry Malaria vaccine Immunogenicity Yellow Fever Vaccine Yellow fever Public Health Environmental and Occupational Health RTS S Infant medicine.disease Infectious Diseases Immunization Child Preschool Molecular Medicine business |
| Zdroj: | Vaccine |
| ISSN: | 0264-410X |
| DOI: | 10.1016/j.vaccine.2020.03.014 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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