Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection.
An effective therapeutic vaccine that could augment immune control of HIV-1 replication may abrogate or delay the need for antiretroviral therapy. AIDS Clinical Trials Group (ACTG) A5187 was a phase I/II, randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity...
Main Authors: | , , , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Public Library of Science (PLoS)
2010-05-01
|
Series: | PLoS ONE |
Online Access: | http://europepmc.org/articles/PMC2866663?pdf=render |
id |
doaj-790158474e81421abf26201fb037c5db |
---|---|
record_format |
Article |
spelling |
doaj-790158474e81421abf26201fb037c5db2020-11-25T01:46:08ZengPublic Library of Science (PLoS)PLoS ONE1932-62032010-05-0155e1055510.1371/journal.pone.0010555Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection.Eric S RosenbergBarney S GrahamEllen S ChanRonald J BoschVicki StockerJanine MaenzaMartin MarkowitzSusan LittlePaul E SaxAnn C CollierGary NabelSuzanne SaindonTheresa FlynnDaniel KuritzkesDan H BarouchAIDS Clinical Trials Group A5187 TeamAn effective therapeutic vaccine that could augment immune control of HIV-1 replication may abrogate or delay the need for antiretroviral therapy. AIDS Clinical Trials Group (ACTG) A5187 was a phase I/II, randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of an HIV-1 DNA vaccine (VRC-HVDNA 009-00-VP) in subjects treated with antiretroviral therapy during acute/early HIV-1 infection. (clinicaltrials.gov NCT00125099)Twenty healthy HIV-1 infected subjects who were treated with antiretroviral therapy during acute/early HIV-1 infection and had HIV-1 RNA<50 copies/mL were randomized to receive either vaccine or placebo. The objectives of this study were to evaluate the safety and immunogenicity of the vaccine. Following vaccination, subjects interrupted antiretroviral treatment, and set-point HIV-1 viral loads and CD4 T cell counts were determined 17-23 weeks after treatment discontinuation.Twenty subjects received all scheduled vaccinations and discontinued antiretroviral therapy at week 30. No subject met a primary safety endpoint. No evidence of differences in immunogenicity were detected in subjects receiving vaccine versus placebo. There were also no significant differences in set-point HIV-1 viral loads or CD4 T cell counts following treatment discontinuation. Median set-point HIV-1 viral loads after treatment discontinuation in vaccine and placebo recipients were 3.5 and 3.7 log(10) HIV-1 RNA copies/mL, respectively.The HIV-1 DNA vaccine (VRC-HIVDNA 009-00-VP) was safe but poorly immunogenic in subjects treated with antiretroviral therapy during acute/early HIV-1 infection. Viral set-points were similar between vaccine and placebo recipients following treatment interruption. However, median viral load set-points in both groups were lower than in historical controls, suggesting a possible role for antiretroviral therapy in persons with acute or early HIV-1 infection and supporting the safety of discontinuing treatment in this group.Clinicaltrials.gov NCT00125099.http://europepmc.org/articles/PMC2866663?pdf=render |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Eric S Rosenberg Barney S Graham Ellen S Chan Ronald J Bosch Vicki Stocker Janine Maenza Martin Markowitz Susan Little Paul E Sax Ann C Collier Gary Nabel Suzanne Saindon Theresa Flynn Daniel Kuritzkes Dan H Barouch AIDS Clinical Trials Group A5187 Team |
spellingShingle |
Eric S Rosenberg Barney S Graham Ellen S Chan Ronald J Bosch Vicki Stocker Janine Maenza Martin Markowitz Susan Little Paul E Sax Ann C Collier Gary Nabel Suzanne Saindon Theresa Flynn Daniel Kuritzkes Dan H Barouch AIDS Clinical Trials Group A5187 Team Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. PLoS ONE |
author_facet |
Eric S Rosenberg Barney S Graham Ellen S Chan Ronald J Bosch Vicki Stocker Janine Maenza Martin Markowitz Susan Little Paul E Sax Ann C Collier Gary Nabel Suzanne Saindon Theresa Flynn Daniel Kuritzkes Dan H Barouch AIDS Clinical Trials Group A5187 Team |
author_sort |
Eric S Rosenberg |
title |
Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. |
title_short |
Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. |
title_full |
Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. |
title_fullStr |
Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. |
title_full_unstemmed |
Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. |
title_sort |
safety and immunogenicity of therapeutic dna vaccination in individuals treated with antiretroviral therapy during acute/early hiv-1 infection. |
publisher |
Public Library of Science (PLoS) |
series |
PLoS ONE |
issn |
1932-6203 |
publishDate |
2010-05-01 |
description |
An effective therapeutic vaccine that could augment immune control of HIV-1 replication may abrogate or delay the need for antiretroviral therapy. AIDS Clinical Trials Group (ACTG) A5187 was a phase I/II, randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of an HIV-1 DNA vaccine (VRC-HVDNA 009-00-VP) in subjects treated with antiretroviral therapy during acute/early HIV-1 infection. (clinicaltrials.gov NCT00125099)Twenty healthy HIV-1 infected subjects who were treated with antiretroviral therapy during acute/early HIV-1 infection and had HIV-1 RNA<50 copies/mL were randomized to receive either vaccine or placebo. The objectives of this study were to evaluate the safety and immunogenicity of the vaccine. Following vaccination, subjects interrupted antiretroviral treatment, and set-point HIV-1 viral loads and CD4 T cell counts were determined 17-23 weeks after treatment discontinuation.Twenty subjects received all scheduled vaccinations and discontinued antiretroviral therapy at week 30. No subject met a primary safety endpoint. No evidence of differences in immunogenicity were detected in subjects receiving vaccine versus placebo. There were also no significant differences in set-point HIV-1 viral loads or CD4 T cell counts following treatment discontinuation. Median set-point HIV-1 viral loads after treatment discontinuation in vaccine and placebo recipients were 3.5 and 3.7 log(10) HIV-1 RNA copies/mL, respectively.The HIV-1 DNA vaccine (VRC-HIVDNA 009-00-VP) was safe but poorly immunogenic in subjects treated with antiretroviral therapy during acute/early HIV-1 infection. Viral set-points were similar between vaccine and placebo recipients following treatment interruption. However, median viral load set-points in both groups were lower than in historical controls, suggesting a possible role for antiretroviral therapy in persons with acute or early HIV-1 infection and supporting the safety of discontinuing treatment in this group.Clinicaltrials.gov NCT00125099. |
url |
http://europepmc.org/articles/PMC2866663?pdf=render |
work_keys_str_mv |
AT ericsrosenberg safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT barneysgraham safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT ellenschan safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT ronaldjbosch safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT vickistocker safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT janinemaenza safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT martinmarkowitz safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT susanlittle safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT paulesax safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT annccollier safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT garynabel safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT suzannesaindon safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT theresaflynn safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT danielkuritzkes safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT danhbarouch safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection AT aidsclinicaltrialsgroupa5187team safetyandimmunogenicityoftherapeuticdnavaccinationinindividualstreatedwithantiretroviraltherapyduringacuteearlyhiv1infection |
_version_ |
1725020677427167232 |