Therapeutic vaccination with p24-VLP and zidovudine augments HIV- specific cytotoxic T lymphocyte activity in asymptomatic HIV-infected individuals

Elizabeth M. Benson, Janett Clarkson, Matthew Law, Philip Marshall, Anthony D. Kelleher, Don E. Smith, Gary Patou, Graeme J. Stewart, David A. Cooper, Rosemary A. Ffrench

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This study evaluates the impact of therapeutic vaccination with p24-VLP and zidovudine on the induction or maintenance of HIV-specific cytotoxic lymphocyte activity in a cohort of asymptomatic patients with CD4 counts greater than 400 cells/μl. In a dummy, randomized, phase II clinical trial of the therapeutic vaccine, participants were randomized to one of three arms for 6 months: p24-VLP (500 μg) in alum monthly plus zidovudine 200 mg tds, alum adjuvant plus zidovudine, or p24-VLP plus placebo. Subjects were studied for a total of 52 weeks from baseline. Monitoring included viral load, CD4 and CD8 counts, markers of immune activation, delayed-type hypersensitivity (DTH) skin testing, and cytotoxic T lymphocyte (CTL) measurement. The nine subjects who received p24-VLP and zidovudine had an augmentation and/or broadening of their CTL response compared with baseline (p = 0.004). The eight subjects receiving p24-VLP and seven subjects receiving zidovudine did not have a statistically significant increase or broadening of CTL activity. The augmentation of the CTL response in the subjects who received p24-VLP and zidovudine was not associated with a decline in viral load or an increase in CD8 counts. This study suggests that HIV-specific CTL activity can be augmented in HIV-infected individuals receiving p24-VLP and zidovudine, supporting the hypothesis of therapeutic vaccination in the presence of antiretroviral therapy.

Original languageEnglish
Pages (from-to)105-113
Number of pages9
JournalAIDS Research and Human Retroviruses
Issue number2
Publication statusPublished - 20 Jan 1999
Externally publishedYes

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