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Authors: S. Emery, A.D. Kelleher, C. Workman, R.L. Puls, M. Bloch, D. Baker, J. Anderson, J. Hoy, S. Ip, K. Nalliah, L.D. Ward, M.G. Law and D.A. Cooper

S. Emery

National Center in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia

A.D. Kelleher

National Center in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia

C. Workman

Ground Zero Medical Centre, Sydney, Australia

R.L. Puls

National Center in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia

M. Bloch

Holdsworth House Medical Practice, Sydney, Australia

D. Baker

407 Doctors, Sydney, Australia

J. Anderson

Carlton Clinic, Melbourne, Australia

J. Hoy

The Alfred Hospital, Melbourne, Australia

S. Ip

National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia

K. Nalliah

National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia

L.D. Ward

Virax Development Pty. Ltd., Melbourne, Australia

M.G. Law

National Center in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia

D.A. Cooper

National Center in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia

Abstract:
Therapeutic immunization to stimulate host immune responses and control human immunodeficiency virus (HIV-1) replication is being investigated as a supplimentary treatment for the management of HIV infection. On completion of an earlier study involving three vaccinations while taking combination antiretroviral therapy (CART), twenty-five subjects with plasma viral load (pVL) <50 copies/mL received a booster vaccination with either placebo (n=7); fowl pox vaccine (rFPV) expressing HIV-1 Gag/Pol; (partial construct- PC (n=8)) or rFPV co-expressing HIV-1 Gag/Pol and human interferon-γ (full construct – FC (n=10)). One week after the booster vaccination, participants stopped ART and were monitored for safety, pVL and immunological parameters for < 20 weeks. The time weighted mean change (SD) from baseline plasma HIV RNA was 1.80 (0.72), 1.78 (0.91) and 0.96 (0.91) log10 copies/mL for placebo, PC and FC recipients respectively (p=0.06; mean differences between placebo and FC). Laboratory evaluations did not reveal differences in anti-HIV specific immune responses between study arms. No difference between treatment arms for host genetic factors known to affect pVL was demonstrated. In conclusion, vaccination with FC was associated with a trend toward lower rates of HIV replication following cessation of ART relative to placebo or PC. The promising antiretrovirological effect supports further study of FC in a larger trial with a broader population of patients with HIV disease.

Received: May 5, 2007; Accepted: June 25, 2007

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