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

The search for a fully protective vaccine against malaria is still ongoing and heterologous prim-boost vaccination is being evaluated as part of the research into novel malaria vaccines.
At the MRC Unit The Gambia at the LSHTM,  Professor Beate Kampmann, Dr Afolabi (Principal Investigator) and the Immunology team conducted a randomised controlled trial study on 65 Gambian infants and newborns aged 16 months, 8 months or a week old, funded by EDCTP in collaboration with our colleagues at Université Cheikh Anta Diop de Dakar  and the University of Oxford. The study was cordinated by the European Vaccine Initiate (EVI).

Sukuta Health Center – Study Trial Site

Infants were randomised to receive either EPI-vaccines only or ChAd63 MVA ME-TRAP plus concomitant EPI vaccinations. 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 titres to EPI vaccines.

There were no reports of vaccine- related serious AEs in any of the infants and good immunogencity was found with high-level TRAP-specific IgG and T cell responses generated after boosting with MVA. CD8+ T cell responses were induced in all groups. ChAd63 MVA ME-TRAP did not reduce the immunogenicity of co-administered EPI vaccines.

The clinical trial was registered on http://Clinicaltrials.gov (NCT02083887) and the Pan-African Clinical Trials Registry (PACTR201402000749217) and first published November 20th 2017 https://www.ncbi.nlm.nih.gov/pubmed/29213269