A Phase IIB, Randomized, Double-Blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in HIV-1-infected Patients

Détails

ID Serval
serval:BIB_A89095C1B5AA
Type
Actes de conférence (partie): contribution originale à la littérature scientifique, publiée à l'occasion de conférences scientifiques, dans un ouvrage de compte-rendu (proceedings), ou dans l'édition spéciale d'un journal reconnu (conference proceedings).
Sous-type
Abstract (résumé de présentation): article court qui reprend les éléments essentiels présentés à l'occasion d'une conférence scientifique dans un poster ou lors d'une intervention orale.
Collection
Publications
Institution
Titre
A Phase IIB, Randomized, Double-Blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in HIV-1-infected Patients
Titre de la conférence
AIDS Vaccine 2011 Conference
Auteur(s)
Rockstroh J.K., Pantaleo G., Pollard R., van Lunzen J., Asmuth D., Peters B., Podzamczer D., Lazzarin A., Ellefsen-Lavoie K., Baksaas I., Sommerfelt M.A., Wendel-Hansen V., Sorensen B.
Adresse
Bangkok, Thailand, September 12-15, 2011
ISBN
0889-2229
Statut éditorial
Publié
Date de publication
2011
Peer-reviewed
Oui
Volume
27
Série
Aids Research and Human Retroviruses
Pages
A129-A130
Langue
anglais
Notes
Publication type : Meeting Abstract
Résumé
Background: Vacc-4x is a peptide-based HIV therapeutic vaccine to conserved domains on p24Gag. Recently conserved 'sectors' on HIV p24, critical for virus viability and thereby immunologically vulnerable have been identified. Elite controllers target immune responses to such regions. The Vacc-4x peptides lie within a number of these conserved sectors of HIV p24. The co-primary endpoints of this study were to compare changes in CD4 counts and return to ART between treatmentand placebo groups during a 24 week treatment interruption. Secondary endpoints included safety, viral load and immunogenicity.Methods: This prospective, randomized, double blind phase IIB clinical study (NCT00659789) was carried out in 13 European and 5 US centers recruiting 135 patients on ART. After 6 immunizations on ART over 28 weeks, treatment was interrupted for up to 24 weeks (to week 52) (Vacc-4x n = 88; placebo n = 38). Immunological analyses (ELISPOT, proliferation, intracellular cytokine staining) were carried out at central laboratories.Results: There were no Vacc-4x-related serious adverse events. Of the 135 patients recruited (male n = 92; female n = 43), 126 patients completed the study. Median prestudy CD4 count was 712 (Vacc-4x) and 619 cells/mm3 (placebo), and median CD4 nadir 300 (Vacc-4x) and 285 cells/mm3 (placebo). There was no statistically significant difference between the two groups regarding change in CD4 counts (p = 0.12) or ART resumption (p = 0.89) during treatment interruption. A statistically significant treatment difference between Vacc-4x and placebo groupsfor viral load (VL) was found for patients who achieved a 6 month ART-free period (p = 0.0022). There was a positive correlation between ELISPOT responses and lower viral load in the Vacc-4x group compared to placebo (p = 0.02). Long-term follow-up of patients up t o week 104 was completed in June 2011.Conclusion: Vacc-4x was found to be safe and well tolerated. TheVacc-4x group experienced a significant reduction in viral load compared to placebo.
Mots-clé
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Web of science
Création de la notice
10/11/2011 10:38
Dernière modification de la notice
20/08/2019 16:13
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