PMID- 29213269
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240306
IS  - 1664-3224 (Print)
IS  - 1664-3224 (Electronic)
IS  - 1664-3224 (Linking)
VI  - 8
DP  - 2017
TI  - Safety and Immunogenicity of Malaria Vectored Vaccines Given with Routine 
      Expanded Program on Immunization Vaccines in Gambian Infants and Neonates: A 
      Randomized Controlled Trial.
PG  - 1551
LID - 10.3389/fimmu.2017.01551 [doi]
LID - 1551
AB  - 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 IFNgamma 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).
FAU - Mensah, Victorine A
AU  - Mensah VA
AD  - Universite Cheikh Anta Diop, Dakar, Senegal.
FAU - Roetynck, Sophie
AU  - Roetynck S
AD  - Medical Research Council Unit, Fajara, Gambia.
FAU - Kanteh, Ebrima K
AU  - Kanteh EK
AD  - Medical Research Council Unit, Fajara, Gambia.
FAU - Bowyer, Georgina
AU  - Bowyer G
AD  - The Jenner Institute Laboratories, University of Oxford, Oxford, United Kingdom.
FAU - Ndaw, Amy
AU  - Ndaw A
AD  - Universite Cheikh Anta Diop, Dakar, Senegal.
FAU - Oko, Francis
AU  - Oko F
AD  - Medical Research Council Unit, Fajara, Gambia.
FAU - Bliss, Carly M
AU  - Bliss CM
AD  - The Jenner Institute Laboratories, University of Oxford, Oxford, United Kingdom.
FAU - Jagne, Ya Jankey
AU  - Jagne YJ
AD  - Medical Research Council Unit, Fajara, Gambia.
FAU - Cortese, Riccardo
AU  - Cortese R
AD  - Keires AG, Basel, Switzerland.
FAU - Nicosia, Alfredo
AU  - Nicosia A
AD  - ReiThera, Rome, Italy.
AD  - CEINGE, Naples, Italy.
AD  - Department of Molecular Medicine and Medical Biotechnology, University Federico 
      II, Naples, Italy.
FAU - Roberts, Rachel
AU  - Roberts R
AD  - Centre for Clinical Vaccinology and Tropical Medicine, The Jenner Institute, 
      Churchill Hospital, Oxford, United Kingdom.
FAU - D'Alessio, Flavia
AU  - D'Alessio F
AD  - European Vaccine Initiative, UniversitatsKlinikum Heidelberg, Heidelberg, 
      Germany.
FAU - Leroy, Odile
AU  - Leroy O
AD  - European Vaccine Initiative, UniversitatsKlinikum Heidelberg, Heidelberg, 
      Germany.
FAU - Faye, Babacar
AU  - Faye B
AD  - Universite Cheikh Anta Diop, Dakar, Senegal.
FAU - Kampmann, Beate
AU  - Kampmann B
AD  - Medical Research Council Unit, Fajara, Gambia.
AD  - Centre for International Child Health, Imperial College London, London, United 
      Kingdom.
FAU - Cisse, Badara
AU  - Cisse B
AD  - Universite Cheikh Anta Diop, Dakar, Senegal.
FAU - Bojang, Kalifa
AU  - Bojang K
AD  - Medical Research Council Unit, Fajara, Gambia.
FAU - Gerry, Stephen
AU  - Gerry S
AD  - Centre for Statistics in Medicine, Botnar Research Centre, Nuffield Department of 
      Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, 
      Oxford, United Kingdom.
FAU - Viebig, Nicola K
AU  - Viebig NK
AD  - European Vaccine Initiative, UniversitatsKlinikum Heidelberg, Heidelberg, 
      Germany.
FAU - Lawrie, Alison M
AU  - Lawrie AM
AD  - Centre for Clinical Vaccinology and Tropical Medicine, The Jenner Institute, 
      Churchill Hospital, Oxford, United Kingdom.
FAU - Clarke, Ed
AU  - Clarke E
AD  - Medical Research Council Unit, Fajara, Gambia.
FAU - Imoukhuede, Egeruan B
AU  - Imoukhuede EB
AD  - Centre for Clinical Vaccinology and Tropical Medicine, The Jenner Institute, 
      Churchill Hospital, Oxford, United Kingdom.
FAU - Ewer, Katie J
AU  - Ewer KJ
AD  - The Jenner Institute Laboratories, University of Oxford, Oxford, United Kingdom.
FAU - Hill, Adrian V S
AU  - Hill AVS
AD  - The Jenner Institute Laboratories, University of Oxford, Oxford, United Kingdom.
AD  - Centre for Clinical Vaccinology and Tropical Medicine, The Jenner Institute, 
      Churchill Hospital, Oxford, United Kingdom.
FAU - Afolabi, Muhammed O
AU  - Afolabi MO
AD  - Medical Research Council Unit, Fajara, Gambia.
LA  - eng
SI  - ClinicalTrials.gov/NCT02083887
GR  - MC_UP_A900_1118/MRC_/Medical Research Council/United Kingdom
GR  - MC_UP_A900_1122/MRC_/Medical Research Council/United Kingdom
GR  - MR/R005990/1/MRC_/Medical Research Council/United Kingdom
PT  - Journal Article
DEP - 20171120
PL  - Switzerland
TA  - Front Immunol
JT  - Frontiers in immunology
JID - 101560960
PMC - PMC5702785
OTO - NOTNLM
OT  - cellular immune response
OT  - clinical trials
OT  - cytokines
OT  - malaria
OT  - vaccines
EDAT- 2017/12/08 06:00
MHDA- 2017/12/08 06:01
PMCR- 2017/01/01
CRDT- 2017/12/08 06:00
PHST- 2017/08/30 00:00 [received]
PHST- 2017/10/31 00:00 [accepted]
PHST- 2017/12/08 06:00 [entrez]
PHST- 2017/12/08 06:00 [pubmed]
PHST- 2017/12/08 06:01 [medline]
PHST- 2017/01/01 00:00 [pmc-release]
AID - 10.3389/fimmu.2017.01551 [doi]
PST - epublish
SO  - Front Immunol. 2017 Nov 20;8:1551. doi: 10.3389/fimmu.2017.01551. eCollection 
      2017.