Trial reportPloS one2010
Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection.
Trial report in PloS one, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safety and Immunogenicity of the HIV-1 DNA Vaccine VRC-HIVDNA009-00-VP (GAG-POL-NEF-MULTICLADE ENV) in HIV-1 Infected Subjects Treated During Acute HIV Infection
A Phase 1 Study of the Safety and Immunogenicity of DNA/MVA Immunizations With Co-Expressed GM-CSF in HIV-1 Infected Young Adults With Suppressed Viremia on HAART
Who cites it
40 citing papers in PubMed, 1 synthesis or guideline pooled it, 73 citations in OpenAlex.
- Time to HIV viral rebound and frequency of post-treatment control after analytical interruption of antiretroviral therapy: an individual data-based meta-analysis of 24 prospective studies.Nature communications · 2025Pooled it
- Time to Viral Rebound After Interruption of Modern Antiretroviral Therapies.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Time to viral rebound and safety after antiretroviral treatment interruption in postpartum women compared with men.AIDS (London, England) · 2019Trial
- A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection.Science translational medicine · 2017Trial
- HIV-1-Specific Antibody Response and Function after DNA Prime and Recombinant Adenovirus 5 Boost HIV Vaccine in HIV-Infected Subjects.PloS one · 2016Trial
- Induction of strong HIV-1-specific CD4+ T-cell responses using an HIV-1 gp120/NefTat vaccine adjuvanted with AS02A in antiretroviral-treated HIV-1-infected individuals.Journal of acquired immune deficiency syndromes (1999) · 2012Trial
- Early Viral Dynamics Predict Human Immunodeficiency Virus Posttreatment Control After Analytic Treatment Interruption.The Journal of infectious diseases · 2025Article
- Viral and immune predictors of HIV posttreatment control.Current opinion in HIV and AIDS · 2025Review
- Smoothed simulated pseudo-maximum likelihood estimation for nonlinear mixed effects models with censored responses.Statistical methods in medical research · 2023Article
- HIV post-treatment controllers have distinct immunological and virological features.Proceedings of the National Academy of Sciences of the United States of America · 2023Article
- Article
- Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations.Current HIV/AIDS reports · 2021Review
- Non-invasive plasma glycomic and metabolic biomarkers of post-treatment control of HIV.Nature communications · 2021Article
- Unified model of short- and long-term HIV viral rebound for clinical trial planning.Journal of the Royal Society, Interface · 2021Article
- A flexible nonlinear mixed effects model for HIV viral load rebound after treatment interruption.Statistics in medicine · 2020Article
- Circulating CD30+CD4+ T Cells Increase Before Human Immunodeficiency Virus Rebound After Analytical Antiretroviral Treatment Interruption.The Journal of infectious diseases · 2020Article
- Comparison of empirical and dynamic models for HIV viral load rebound after treatment interruption.Statistical communications in infectious diseases · 2020Article
- Predictions of time to HIV viral rebound following ART suspension that incorporate personal biomarkers.PLoS computational biology · 2019Article
- Learning From the Exceptions: HIV Remission in Post-treatment Controllers.Frontiers in immunology · 2019Review
- The Control of HIV After Antiretroviral Medication Pause (CHAMP) Study: Posttreatment Controllers Identified From 14 Clinical Studies.The Journal of infectious diseases · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 8 institutions in 1 country.
Funding
Abstract
backgroundAn 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)
methodsTwenty 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.
resultsTwenty 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.
conclusionsThe 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.
trial registrationClinicaltrials.gov NCT00125099.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.