Journal article
Safety and immunogenicity of malaria vectored vaccines given with routine EPI vaccines in Gambian infants and neonates: a randomized controlled trial
- Abstract:
-
Background: Heterologous prime-boost vaccination with ChAd63 and MVA encoding 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 Programme on Immunization (EPI) vaccines.
Methods: We enrolled 65 Gambian infants and neonates, aged sixteen, eight or one 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. Immunogenicity was evaluated using IFNγ ELISpot, 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 adverse events. 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. Trial registration
The clinical trial was registered on Clinicaltrials.gov (NCT02083887) and the Pan-African Clinical Trials Registry (PACTR201402000749217).
- Publication status:
- Published
- Peer review status:
- Peer reviewed
Actions
Access Document
- Files:
-
-
(Preview, Version of record, pdf, 2.3MB, Terms of use)
-
- Publisher copy:
- 10.3389/fimmu.2017.01551
Authors
- Grant:
- SP.2011.41304.025
- Publisher:
- Frontiers Media
- Journal:
- Frontiers in Immunology More from this journal
- Volume:
- 8
- Issue:
- 1551
- Pages:
- 1-17
- Publication date:
- 2017-11-20
- Acceptance date:
- 2017-10-31
- DOI:
- ISSN:
-
1664-3224
- Pubs id:
-
pubs:739211
- UUID:
-
uuid:8c34f703-564b-4fc1-86a9-f226f9a31547
- Local pid:
-
pubs:739211
- Source identifiers:
-
739211
- Deposit date:
-
2017-10-31
Terms of use
- Copyright holder:
- © 2017 Mensah, et al
- Copyright date:
- 2017
- Notes:
- 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.
- Licence:
- CC Attribution (CC BY)
If you are the owner of this record, you can report an update to it here: Report update to this record