McCormack, Sheena and Stohr, Wolfgang and Barber, Tristan and Bart, Pierre-Alexandre and Harari, Alexandre and Moog, Christiane and Ciuffreda, Donatella and Cellerai, Cristina and Cowen, Miranda and Gamboni, Romilda and Burnet, Severine and Legg, Ken and Brodnicki, Elizabeth and Wolf, Hans and Wagner, Ralf and Heeney, Jonathan and Frachette, Marie-Joelle and Tartaglia, Jim and Babiker, Abdel and Pantaleo, Giuseppe and Weber, Jonathan (2008) EV02: A Phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone. VACCINE, 26 (25). pp. 3162-3174. ISSN 0264-410X, 1873-2518
Full text not available from this repository. (Request a copy)Abstract
The aim of this randomised controlled trial was to see if the addition of 4mg/ml DNA-C priming given by the intramuscular route at weeks 0 and 4 to NYVAC-C at weeks 20 and 24, safety 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 (11 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. (C) 2008 Elsevier Ltd. AR rights reserved.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | T-CELL RESPONSES; MALE CIRCUMCISION; INFECTED PATIENTS; VACCINE; PREVENTION; MEN; IGG; HIV preventative vaccine; phase 1; DNA-C |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Medizinische Mikrobiologie und Hygiene |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 29 Oct 2020 09:56 |
| Last Modified: | 29 Oct 2020 09:56 |
| URI: | https://pred.uni-regensburg.de/id/eprint/30739 |
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