15th International AIDS Conference Bangkok, Thailand - July 11-16, 2004

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. ThOrA1348)

Pantaleo G, Bart PA, Frachette MJ, Goodall RL, Khonkarly M, Legg K, Mackie N, McCormack S, Weber J
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland

BACKGROUND: EuroVacc is a scientific programme to design, manufacture and assess pre-clinically 7 candidate HIV vaccines, prior to conducting human and primate clinical trials. The first to emerge from this pipeline into a randomised, blinded clinical trial is NYVAC-HIVC, a recombinant NYVAC (vP866) strain with an insert containing gag-pol-nef polyprotein and env both derived from the Chinese R5 HIV clade C virus (97CN54) (1).

METHODS: 24 healthy low risk HIV negative volunteers were recruited from two clinical sites: CHUV, Lausanne and Imperial College, London. Randomisation to NYVAC-HIVC (n=20) or placebo (n=4) was stratified by clinical site. Scheduled immunisations at weeks 0 and 4 began in August 2003. The primary safety endpoints are grade 3 (severe) or 4 (extreme) adverse events (AE) reported within 28 days of an immunisation, presented as a proportion of participants exposed to NYVAC-HIVC with 95% confidence intervals, and any events leading to discontinuation of the immunisation schedule. The primary end-point for the descriptive immunogenicity analyses is week 6 for IFNgamma and week 8 for IL-2 ELIspot responses and binding antibodies to CN54.

RESULTS: 24 (13 male) of 32 volunteers screened have been enrolled and received both immunisations. On 18th November 2003, 28 day follow-up data were available for 42 immunisations (24 first and 18 second) and 7 day follow up for the remaining 6. There have been no serious AE. 92 solicited grade 1 or 2 local or systemic AE were reported by 21 participants lasting a median of 2 days (IQR 1 - 2 days), and a maximum of 8 days. 53 AE (45 grade 1, 8 grade 2) were after the first immunisation and 39 (38 grade 1, 1 grade 2) after the second. 9 grade 1 non-solicited AE were reported, two after the first immunisation and 7 after the second. Immunogenicity data will be presented. Conclusion To date the vaccine has been well-tolerated with mild local and systemic adverse events only.1. Su L et al J Virol 2000 74:11367-76

040711
ThOrA1348

Copyright © 2004 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.