Trial reportJournal of acquired immune deficiency syndromes (1999)2007
Safety and immunogenicity of a Gag-Pol candidate HIV-1 DNA vaccine administered by a needle-free device in HIV-1-seronegative subjects.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.
- Effect of rAd5-Vector HIV-1 Preventive Vaccines on HIV-1 Acquisition: A Participant-Level Meta-Analysis of Randomized Trials.PloS one · 2015Pooled it
- Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine.The New England journal of medicine · 2013Trial
- Trial
- Non-immunogenicity of overlapping gag peptides pulsed on autologous cells after vaccination of HIV infected individuals.PloS one · 2013Trial
- Trial
- DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials.The Lancet. Infectious diseases · 2011Trial
- Timing of plasmid cytokine (IL-2/Ig) administration affects HIV-1 vaccine immunogenicity in HIV-seronegative subjects.The Journal of infectious diseases · 2011Trial
- Trial
- Trial
- Phase I study of a herpes simplex virus type 2 (HSV-2) DNA vaccine administered to healthy, HSV-2-seronegative adults by a needle-free injection system.Clinical and vaccine immunology : CVI · 2008Trial
- The safety and tolerability of an HIV-1 DNA prime-protein boost vaccine (DP6-001) in healthy adult volunteers.Vaccine · 2008Trial
- Multifunctional T-cell characteristics induced by a polyvalent DNA prime/protein boost human immunodeficiency virus type 1 vaccine regimen given to healthy adults are dependent on the route and dose of administration.Journal of virology · 2008Trial
- Exploring the Potential of a Genome-ReducedInternational journal of molecular sciences · 2023Article
- Vaccination against Bacterial Infections: Challenges, Progress, and New Approaches with a Focus on Intracellular Bacteria.Vaccines · 2022Review
- Toward DNA-Based T-Cell Mediated Vaccines to Target HIV-1 and Hepatitis C Virus: Approaches to Elicit Localized Immunity for Protection.Frontiers in cellular and infection microbiology · 2019Review
- Live Bacterial Vectors-A Promising DNA Vaccine Delivery System.Medical sciences (Basel, Switzerland) · 2018Review
- Intranasal DNA Vaccine for Protection against Respiratory Infectious Diseases: The Delivery Perspectives.Pharmaceutics · 2014Article
- HIV DNA Vaccine: Stepwise Improvements Make a Difference.Vaccines · 2014Review
- Recent Developments in Preclinical DNA Vaccination.Vaccines · 2014Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 1 institution in 1 country.
Funding
Abstract
objectiveTo evaluate the safety and immunogenicity of a candidate HIV DNA vaccine administered using a needle-free device.
designIn this phase 1, dose escalation, double-blind, placebo-controlled clinical trial, 21 healthy adults were randomized to receive placebo or 0.5, 1.5, or 4 mg of a single plasmid expressing a Gag/Pol fusion protein. Each participant received repeat immunizations at days 28 and 56 after the first inoculation. Safety and immunogenicity data were collected.
resultsThe vaccine was well tolerated, with most adverse events being mild injection site reactions, including pain, tenderness, and erythema. No dose-limiting toxicities occurred. HIV-specific antibody response was not detected in any vaccinee by enzyme-linked immunosorbent assay. HIV-specific T-cell responses to Gag or Pol as measured by enzyme-linked immunospot assay and intracellular cytokine staining were of low frequency and magnitude.
conclusionsThis candidate HIV DNA vaccine was safe and well tolerated. No HIV-specific antibody responses were detected, and only low-magnitude HIV-specific T-cell responses were detected in 8 (53%) of 15 vaccinees. This initial product led to the development of a 4-plasmid multiclade HIV DNA Vaccine Research Center vaccine candidate in which envelope genes expressing Env from clades A, B, and C and a Nef gene from clade B have been added.
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.