Third International Congress Drug Therapy in HIV Infection 3-7 November 1996 Glasgow, UK

MULTICENTER STUDY OF SAFETY AND IMMUNOGENICITY OF HIV-1 rpg160 CANDIDATE VACCINE IN SEROPOSITIVE HIV-1 VOLUNTEERS

F.D. Goebel, J.W. Mannhalter, M.M. Eibl, RB. Belshe, P. Grob, V. Erfle, P.D.Griffiths, B. Wahren, K. Krohn, M. Kunschak , W. Engl for the European Multinational IMMUNO AIDS-vaccine study group.
Univ. Munich, IMMUNO AG, Vienna, Univ.St. Louis, Univ. Zürich, GSF, Munich, Royal Free Hospital, London, Karolinska Institute, Swed.Inst.Inf.Dis.Control, Stockholm, Univ. Tampere

Int Cong Drug Therapy HIV 1996 Nov 3-7;3:Abstract No. OP6.4
AIDS 1996, Vol. 10 (Suppl. 2);S14

(i) The purpose of the study was to determine safety and immunological response to vaccination with IMMUNO HIV-1 rgp160 candidate vaccine. To determine the effect of vaccination on viral load and time to disease progression.

(ii) Double-blind, placebo (adjuvans) controlled, multinational phase I/II vaccine study of 24 months duration which enrolled 208 pts. in 2 groups with CD4+ cells > 500/µl (#1) and 200-500/µl (#2). 1:1 randomization to receive either 100 µg rgp160 IIIB vaccine or placebo 6 times at monthly intervals and 3 booster injections with rgp160 MN at months 15, 18 and 21. In a subset of pts. lymphoproliferative response, plasma viral RNA, proviral DNA and skin-testing with the vaccine antigen (month 24) were evaluated.

(iii) Apart from local reactions after both vaccine and placebo injections no serious adverse reactions were observed. After vaccination 13/14 vaccine and 2/13 placebo recipients of study #1 and 14/24 vaccine and 1/24 placebo recipients of study #2 responded with rgp160-specific lymphoproliferation. There was a strong correlation between lymphoproliferation and a positive skin test result at the end of the study. Plasma-HIV-RNA at baseline was highly predictive for the clinical outcome. Overall, there were no signifcant differences between vaccine and placebo recipients for plasma-RNA, viral-DNA and CD4+, CD8+, CD3+ cells during the study period. In the subgroup of pts. on antiretroviral compounds at study entry, vaccine recipients showed a tendency, however without statistical significance, towards lower viral RNA, proviral DNA and fewer HIV associated events as compared to the placebo group.

(iv) In conclusion, the administration of rgp160 candidate vaccine appeared to be safe and immunogenic. T-cell-subsets, viral-load and clinical course did not seem to be affected by the vaccine in the whole study population. Subgroup analysis provided information important for further studies.

Presenting author: F.D. Goebel

1996-11-03
OP6.4

Originally published in AIDS Volume 10, Supplement 2 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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