EV02: a Phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone.
Détails
ID Serval
serval:BIB_6443A01EDC31
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
EV02: a Phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone.
Périodique
Vaccine
ISSN
0264-410X
Statut éditorial
Publié
Date de publication
2008
Peer-reviewed
Oui
Volume
26
Numéro
25
Pages
3162-3174
Langue
anglais
Résumé
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.
Mots-clé
AIDS Vaccines, Adult, Antigens, Viral, Drug Design, Female, HIV Infections, HIV-1, Humans, Immunization, Secondary, Injections, Intramuscular, Male, Safety, Viral Vaccines, env Gene Products, Human Immunodeficiency Virus
Pubmed
Web of science
Création de la notice
23/03/2009 11:59
Dernière modification de la notice
20/08/2019 15:20