Safety and immunogenicity of malaria vectored vaccines given with routine expanded program on immunization vaccines in Gambian infants and neonates: a randomized controlled trial

Mensah, Victorine A., Roetynck, Sophie, Kanteh, Ebrima K., Bowyer, Georgina, Ndaw, Amy, Oko, Francis, Bliss, Carly M., Jagne, Ya Jankey, Cortese, Riccardo, Nicosia, Alfredo, Roberts, Rachel, D'Alessio, Flavia, Leroy, Odile, Faye, Babacar, Kampmann, Beate, Cisse, Badara, Bojang, Kalifa, Gerry, Stephen, Viebig, Nicola K., Lawrie, Alison M., Clarke, Ed, Imoukhuede, Egeruan B., Ewer, Katie J., Hill, Adrian V. S. and Afolabi, Muhammed O. 2017. Safety and immunogenicity of malaria vectored vaccines given with routine expanded program on immunization vaccines in Gambian infants and neonates: a randomized controlled trial. Frontiers in Immunology 8 , 1551. 10.3389/fimmu.2017.01551

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Abstract

Background: Heterologous prime-boost vaccination with chimpanzee adenovirus 63 (ChAd63) and modified vaccinia virus Ankara (MVA) encoding multiple epitope string thrombospondin-related adhesion protein (ME-TRAP) has shown acceptable safety and promising immunogenicity in African adult and pediatric populations. If licensed, this vaccine could be given to infants receiving routine childhood immunizations. We therefore evaluated responses to ChAd63 MVA ME-TRAP when co-administered with routine Expanded Program on Immunization (EPI) vaccines. Methods: We enrolled 65 Gambian infants and neonates, aged 16, 8, or 1 week at first vaccination and randomized them to receive either ME-TRAP and EPI vaccines or EPI vaccines only. Safety was assessed by the description of vaccine-related adverse events (AEs). Immunogenicity was evaluated using IFNγ enzyme-linked immunospot, whole-blood flow cytometry, and anti-TRAP IgG ELISA. Serology was performed to confirm all infants achieved protective titers to EPI vaccines. Results: The vaccines were well tolerated in all age groups with no vaccine-related serious AEs. High-level TRAP-specific IgG and T cell responses were generated after boosting with MVA. CD8+ T cell responses, previously found to correlate with protection, were induced in all groups. Antibody responses to EPI vaccines were not altered significantly. Conclusion: Malaria vectored prime-boost vaccines co-administered with routine childhood immunizations were well tolerated. Potent humoral and cellular immunity induced by ChAd63 MVA ME-TRAP did not reduce the immunogenicity of co-administered EPI vaccines, supporting further evaluation of this regimen in infant populations.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Additional Information:	This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
Publisher:	Frontiers Media
ISSN:	1664-3224
Date of First Compliant Deposit:	5 January 2021
Date of Acceptance:	31 October 2017
Last Modified:	06 May 2023 03:12
URI:	https://orca.cardiff.ac.uk/id/eprint/137193

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