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Safety, immunogenicity and efficacy assessment of HIV immunotherapy in a multi-centre, double-blind, randomised, Placebo-controlled Phase Ib human trial.

Abstract：

BACKGROUND:Combination antiretroviral therapy (cART) is the main therapeutic management tool for HIV/AIDS. Despite its success in controlling viral load and disease progression, cART is expensive, associated with a range of significant side effects and depends for its efficacy on the patient's life-long commitment to high levels of treatment adherence. Immunotherapeutic agents can provide potential solutions to these shortcomings. Here we describe a Phase Ib trial of HIV-v, a synthetic immunotherapy that elicits T- and B-cell effector responses against HIV infected cells. METHODS:Fifty-nine cART-naive HIV-infected males aged 18-50 years with viral load of 5000-500,000 copies/ml and CD4 counts >350/μl were recruited for this multi-centre, randomised, double blind study. Volunteers received one low (250 μg) or high (500 μg) dose of HIV-v, either alone or adjuvanted (ISA-51). Safety, immunogenicity, CD4 count and viral load were monitored over 168 Days. RESULTS:HIV-v was well tolerated and the adjuvanted formulations elicited IgG responses in up to 75% of volunteers. The high adjuvanted dose also elicited cellular responses in 45% of tested volunteers. In these responding subjects viral loads were reduced by over 1 log (p=0.04) compared to Placebo and non-responders. No changes in CD4 count were observed. CONCLUSIONS:HIV-v is safe and can elicit T- and B-cell responses in ART-naive HIV patients that significantly reduce viral load. Improved dosing regimens and further research on long term efficacy are required, but HIV-v appears to have potential as an immunotherapeutic anti-viral agent. Trial registered as EudraCT-2009-010593-37 (ClinicalTrials.gov Identifier: NCT01071031).

journal_name

Vaccine

journal_title

Vaccine

authors

Boffito M,Fox J,Bowman C,Fisher M,Orkin C,Wilkins E,Jackson A,Pleguezuelos O,Robinson S,Stoloff GA,Caparrós-Wanderley W

doi

10.1016/j.vaccine.2013.09.057

subject

Has Abstract

pub_date

2013-11-19 00:00:00

pages

5680-6

issue

48

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(13)01327-3

journal_volume

31

pub_type

杂志文章,多中心研究,随机对照试验

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