Literature DB >> 18502003

EV02: a Phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone.

Sheena McCormack1, Wolfgang Stöhr, Tristan Barber, Pierre-Alexandre Bart, Alexandre Harari, Christiane Moog, Donatella Ciuffreda, Cristina Cellerai, Miranda Cowen, Romilda Gamboni, Séverine Burnet, Ken Legg, Elizabeth Brodnicki, Hans Wolf, Ralf Wagner, Jonathan Heeney, Marie-Joëlle Frachette, Jim Tartaglia, Abdel Babiker, Giuseppe Pantaleo, Jonathan Weber.   

Abstract

The aim of this randomised controlled trial was to see if the addition of 4 mg/ml DNA-C priming given by the intramuscular route at weeks 0 and 4 to NYVAC-C at weeks 20 and 24, safely increased the proportion of participants with HIV-specific T-cell responses measured by the interferon (IFN)-gamma ELISpot assay at weeks 26 and/or 28 compared to NYVAC-C alone. Although 2 individuals discontinued after the first DNA-C due to adverse events (1 vaso-vagal; 1 transient, asymptomatic elevation in alanine transaminase), the vaccines were well tolerated. Three others failed to complete the regimen (1 changed her mind; 2 lost to follow-up). Of the 35 that completed the regimen 90% (18/20) in the DNA-C group had ELISpot responses compared to 33% (5/15) that received NYVAC-C alone (p=0.001). Responses were to envelope in the majority (21/23). Of the 9 individuals with responses to envelope and other peptides, 8 were in the DNA-C group. These promising results suggest that DNA-C was an effective priming agent, that merits further investigation.

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Year:  2008        PMID: 18502003     DOI: 10.1016/j.vaccine.2008.02.072

Source DB:  PubMed          Journal:  Vaccine        ISSN: 0264-410X            Impact factor:   3.641


  58 in total

1.  Superior induction of T cell responses to conserved HIV-1 regions by electroporated alphavirus replicon DNA compared to that with conventional plasmid DNA vaccine.

Authors:  Maria L Knudsen; Alice Mbewe-Mvula; Maximillian Rosario; Daniel X Johansson; Maria Kakoulidou; Anne Bridgeman; Arturo Reyes-Sandoval; Alfredo Nicosia; Karl Ljungberg; Tomás Hanke; Peter Liljeström
Journal:  J Virol       Date:  2012-02-08       Impact factor: 5.103

2.  Phase 1 safety and immunogenicity testing of DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles.

Authors:  Paul A Goepfert; Marnie L Elizaga; Alicia Sato; Li Qin; Massimo Cardinali; Christine M Hay; John Hural; Stephen C DeRosa; Olivier D DeFawe; Georgia D Tomaras; David C Montefiori; Yongxian Xu; Lilin Lai; Spyros A Kalams; Lindsey R Baden; Sharon E Frey; William A Blattner; Linda S Wyatt; Bernard Moss; Harriet L Robinson
Journal:  J Infect Dis       Date:  2011-01-31       Impact factor: 5.226

Review 3.  HIV vaccines: lessons learned and the way forward.

Authors:  Jerome H Kim; Supachai Rerks-Ngarm; Jean-Louis Excler; Nelson L Michael
Journal:  Curr Opin HIV AIDS       Date:  2010-09       Impact factor: 4.283

4.  Head-to-Head Comparison of Poxvirus NYVAC and ALVAC Vectors Expressing Identical HIV-1 Clade C Immunogens in Prime-Boost Combination with Env Protein in Nonhuman Primates.

Authors:  Juan García-Arriaza; Beatriz Perdiguero; Jonathan Heeney; Michael Seaman; David C Montefiori; Celia Labranche; Nicole L Yates; Xiaoying Shen; Georgia D Tomaras; Guido Ferrari; Kathryn E Foulds; Adrian McDermott; Shing-Fen Kao; Mario Roederer; Natalie Hawkins; Steve Self; Jiansheng Yao; Patrick Farrell; Sanjay Phogat; Jim Tartaglia; Susan W Barnett; Brian Burke; Anthony Cristillo; Deborah Weiss; Carter Lee; Karen Kibler; Bert Jacobs; Benedikt Asbach; Ralf Wagner; Song Ding; Giuseppe Pantaleo; Mariano Esteban
Journal:  J Virol       Date:  2015-06-03       Impact factor: 5.103

5.  Phase 1 safety and immunogenicity evaluation of ADMVA, a multigenic, modified vaccinia Ankara-HIV-1 B'/C candidate vaccine.

Authors:  Sandhya Vasan; Sarah J Schlesinger; Zhiwei Chen; Arlene Hurley; Angela Lombardo; Soe Than; Phumla Adesanya; Catherine Bunce; Mark Boaz; Rosanne Boyle; Eddy Sayeed; Lorna Clark; Daniel Dugin; Mar Boente-Carrera; Claudia Schmidt; Qing Fang; Yaoxing Huang; Gerasimos J Zaharatos; David F Gardiner; Marina Caskey; Laura Seamons; Martin Ho; Len Dally; Carol Smith; Josephine Cox; Dilbinder Gill; Jill Gilmour; Michael C Keefer; Patricia Fast; David D Ho
Journal:  PLoS One       Date:  2010-01-25       Impact factor: 3.240

6.  Phase 1 safety and immunogenicity evaluation of ADVAX, a multigenic, DNA-based clade C/B' HIV-1 candidate vaccine.

Authors:  Sandhya Vasan; Sarah J Schlesinger; Yaoxing Huang; Arlene Hurley; Angela Lombardo; Zhiwei Chen; Soe Than; Phumla Adesanya; Catherine Bunce; Mark Boaz; Rosanne Boyle; Eddy Sayeed; Lorna Clark; Daniel Dugin; Claudia Schmidt; Yang Song; Laura Seamons; Len Dally; Martin Ho; Carol Smith; Martin Markowitz; Josephine Cox; Dilbinder K Gill; Jill Gilmour; Michael C Keefer; Patricia Fast; David D Ho
Journal:  PLoS One       Date:  2010-01-25       Impact factor: 3.240

7.  Immunogenic profiling in mice of a HIV/AIDS vaccine candidate (MVA-B) expressing four HIV-1 antigens and potentiation by specific gene deletions.

Authors:  Juan García-Arriaza; José Luis Nájera; Carmen E Gómez; Carlos Oscar S Sorzano; Mariano Esteban
Journal:  PLoS One       Date:  2010-08-24       Impact factor: 3.240

8.  Enhancement of the priming efficacy of DNA vaccines encoding dendritic cell-targeted antigens by synergistic toll-like receptor ligands.

Authors:  Claudius Grossmann; Matthias Tenbusch; Godwin Nchinda; Vladimir Temchura; Ghulam Nabi; Geoffrey W Stone; Richard S Kornbluth; Klaus Uberla
Journal:  BMC Immunol       Date:  2009-08-03       Impact factor: 3.615

9.  Vaccinia virus strain NYVAC induces substantially lower and qualitatively different human antibody responses compared with strains Lister and Dryvax.

Authors:  Claire M Midgley; Mike M Putz; Jonathan N Weber; Geoffrey L Smith
Journal:  J Gen Virol       Date:  2008-12       Impact factor: 3.891

10.  Improved efficacy of a gene optimised adenovirus-based vaccine for venezuelan equine encephalitis virus.

Authors:  Amanda J Williams; Lyn M O'Brien; Robert J Phillpotts; Stuart D Perkins
Journal:  Virol J       Date:  2009-07-31       Impact factor: 4.099

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