Imperial College London
Portrait Picture

DrTonyTarragona-Fiol

Faculty of Medicine, Department of Surgery & Cancer

Divisional Manager
 
 
 
//

Contact

 

+44 (0)20 3312 7619t.tarragona

 
 
//

Location

 

1030Queen Elizabeth the Queen Mother Wing (QEQM)St Mary's Campus

//

Summary

 

Publications

Citation

BibTex format

@article{Keefer:2012:10.1371/journal.pone.0041936,
author = {Keefer, MC and Gilmour, J and Hayes, P and Gill, D and Kopycinski, J and Cheeseman, H and Cashin-Cox, M and Naarding, M and Clark, L and Fernandez, N and Bunce, CA and Hay, CM and Welsh, S and Komaroff, W and Hachaambwa, L and Tarragona-Fiol, T and Sayeed, E and Zachariah, D and Ackland, J and Loughran, K and Barin, B and Cormier, E and Cox, JH and Fast, P and Excler, J-L},
doi = {10.1371/journal.pone.0041936},
journal = {PLoS One},
title = {A phase I double blind, placebo-controlled, randomized study of a multigenic HIV-1 adenovirus subtype 35 vector vaccine in healthy uninfected adults.},
url = {http://dx.doi.org/10.1371/journal.pone.0041936},
volume = {7},
year = {2012}
}
Download

RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BACKGROUND: We conducted a phase I, randomized, double-blind, placebo-controlled trial to assess the safety and immunogenicity of escalating doses of two recombinant replication defective adenovirus serotype 35 (Ad35) vectors containing gag, reverse transcriptase, integrase and nef (Ad35-GRIN) and env (Ad35-ENV), both derived from HIV-1 subtype A isolates. The trial enrolled 56 healthy HIV-uninfected adults. METHODS: Ad35-GRIN/ENV (Ad35-GRIN and Ad35-ENV mixed in the same vial in equal proportions) or Ad35-GRIN was administered intramuscularly at 0 and 6 months. Participants were randomized to receive either vaccine or placebo (10/4 per group, respectively) within one of four dosage groups: Ad35-GRIN/ENV 2×10(9) (A), 2×10(10) (B), 2×10(11) (C), or Ad35-GRIN 1×10(10) (D) viral particles. RESULTS: No vaccine-related serious adverse event was reported. Reactogenicity events reported were dose-dependent, mostly mild or moderate, some severe in Group C volunteers, all transient and resolving spontaneously. IFN-γ ELISPOT responses to any vaccine antigen were detected in 50, 56, 70 and 90% after the first vaccination, and in 75, 100, 88 and 86% of Groups A-D vaccine recipients after the second vaccination, respectively. The median spot forming cells (SFC) per 10(6) PBMC to any antigen was 78-139 across Groups A-C and 158-174 in Group D, after each of the vaccinations with a maximum of 2991 SFC. Four to five HIV proteins were commonly recognized across all the groups and over multiple timepoints. CD4+ and CD8+ T-cell responses were polyfunctional. Env antibodies were detected in all Group A-C vaccinees and Gag antibodies in most vaccinees after the second immunization. Ad35 neutralizing titers remained low after the second vaccination. CONCLUSION/SIGNIFICANCE: Ad35-GRIN/ENV reactogenicity was dose-related. HIV-specific cellular and humoral responses were seen in the majority of volunteers immunized with Ad35-GRIN/ENV or Ad35-GRIN and increased
AU  - Keefer,MC
AU  - Gilmour,J
AU  - Hayes,P
AU  - Gill,D
AU  - Kopycinski,J
AU  - Cheeseman,H
AU  - Cashin-Cox,M
AU  - Naarding,M
AU  - Clark,L
AU  - Fernandez,N
AU  - Bunce,CA
AU  - Hay,CM
AU  - Welsh,S
AU  - Komaroff,W
AU  - Hachaambwa,L
AU  - Tarragona-Fiol,T
AU  - Sayeed,E
AU  - Zachariah,D
AU  - Ackland,J
AU  - Loughran,K
AU  - Barin,B
AU  - Cormier,E
AU  - Cox,JH
AU  - Fast,P
AU  - Excler,J-L
DO  - 10.1371/journal.pone.0041936
PY  - 2012///
TI  - A phase I double blind, placebo-controlled, randomized study of a multigenic HIV-1 adenovirus subtype 35 vector vaccine in healthy uninfected adults.
T2  - PLoS One
UR  - http://dx.doi.org/10.1371/journal.pone.0041936
UR  - https://www.ncbi.nlm.nih.gov/pubmed/22870265
UR  - http://hdl.handle.net/10044/1/10157
VL  - 7
ER  -
Download