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

•First RTS,S/AS01 dose was given with Vitamin A supplementation at 6 months of age.•Third RTS,S/AS01 dose was given with yellow fever and measles-rubella vaccines at 9 months.•Immune responses following co-administration met all non-inferiority criteria.•The safety profile of the vaccines was clinic...

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Published in:Vaccine 2020-04, Vol.38 (18), p.3411-3421
Main Authors: Asante, Kwaku Poku, Ansong, Daniel, Kaali, Seyram, Adjei, Samuel, Lievens, Marc, Nana Badu, Lydia, Agyapong Darko, Prince, Boakye Yiadom Buabeng, Patrick, Boahen, Owusu, Maria Rettig, Theresa, Agutu, Clara, Benard Ekow Harrison, Samuel, Ntiamoah, Yaw, Adomako Anim, Japhet, Adeniji, Elisha, Agordo Dornudo, Albert, Gvozdenovic, Emilia, Dosoo, David, Sambian, David, Owusu-Boateng, Harry, Ato Wilson, Elvis, Prempeh, Frank, Vandoolaeghe, Pascale, Schuerman, Lode, Owusu-Agyei, Seth, Agbenyega, Tsiri, Ofori-Anyinam, Opokua
Format: Article
Language:English
Subjects:
Age
Antibodies
Antigens
Child
Child, Preschool
Children
Circumsporozoite protein
Co-administration
Combined vaccines
Drug dosages
Enzymes
Evaluation
Fever
Ghana
Hepatitis
Hepatitis B
Humans
Immune response
Immune system
Immunization
Immunogenicity
Infant
Laboratories
Malaria
Malaria Vaccines - adverse effects
Measles
Non-inferiority
Randomization
Retinene
RTS
Rubella
Rubella - prevention & control
S/AS01
Safety
Supplements
Surface antigens
Tropical diseases
Vaccines
Vector-borne diseases
Viruses
Vitamin A
Yellow fever
Yellow Fever Vaccine - adverse effects
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Summary:•First RTS,S/AS01 dose was given with Vitamin A supplementation at 6 months of age.•Third RTS,S/AS01 dose was given with yellow fever and measles-rubella vaccines at 9 months.•Immune responses following co-administration met all non-inferiority criteria.•The safety profile of the vaccines was clinically acceptable when co-administered.•RTS,S/AS01 can be given with Vitamin A, yellow fever and measles-rubella vaccines. 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. 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. 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. 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.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2020.03.014