Safety and Immunogenicity of Malaria Vectored Vaccines Given with Routine Expanded Program on Immunization Vaccines in Gambian Infants and Neonates: A Randomized Controlled Trial

Overview

Journal Front Immunol

Specialty Allergy & Immunology

Date 2017 Dec 8

PMID 29213269

Citations 18

Authors

Victorine A Mensah

Sophie Roetynck

Ebrima K Kanteh

Georgina Bowyer

Amy Ndaw

Francis Oko

Carly M Bliss

Ya Jankey Jagne

Riccardo Cortese

Alfredo Nicosia

Rachel Roberts

Flavia DAlessio

Odile Leroy

Babacar Faye

Beate Kampmann

Badara Cisse

Kalifa Bojang

Stephen Gerry

Nicola K Viebig

Alison M Lawrie

Ed Clarke

Egeruan B Imoukhuede

Katie J Ewer

Adrian V S Hill

Muhammed O Afolabi

Affiliations

Soon will be listed here.

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.

Clinical Trial Registration: The clinical trial was registered on http://Clinicaltrials.gov (NCT02083887) and the Pan-African Clinical Trials Registry (PACTR201402000749217).

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