Trial reportPloS one2012
Safety and immunogenicity of an HIV-1 gag DNA vaccine with or without IL-12 and/or IL-15 plasmid cytokine adjuvant in healthy, HIV-1 uninfected adults.
Trial report in PloS one, 2012. 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 74 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.
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Gag DNA Vaccine With or Without IL-12 DNA Adjuvant, Boosted With Homologous Plasmids in Healthy, HIV-1 Uninfected Adult Participants
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Gag DNA Vaccine Alone or With IL-15 DNA, Boosted With HIV-1 Gag DNA + IL-15 DNA or HIV-1 Gag DNA + IL-12 DNA, in Healthy, HIV-1 Uninfected Adult Participants
Who cites it
74 citing papers in PubMed, 1 synthesis or guideline pooled it, 110 citations in OpenAlex.
- Controlling timing and location in vaccines.Advanced drug delivery reviews · 2020Pooled it
- Focusing HIV-1 Gag T cell responses to highly conserved regions by DNA vaccination in HVTN 119.JCI insight · 2024Trial
- Personalized neoantigen vaccine and pembrolizumab in advanced hepatocellular carcinoma: a phase 1/2 trial.Nature medicine · 2024Trial
- Trial
- DNA Priming Increases Frequency of T-Cell Responses to a Vesicular Stomatitis Virus HIV Vaccine with Specific Enhancement of CD8Clinical and vaccine immunology : CVI · 2017Trial
- First-in-Human Evaluation of the Safety and Immunogenicity of an Intranasally Administered Replication-Competent Sendai Virus-Vectored HIV Type 1 Gag Vaccine: Induction of Potent T-Cell or Antibody Responses in Prime-Boost Regimens.The Journal of infectious diseases · 2017Trial
- Trial
- Safety and comparative immunogenicity of an HIV-1 DNA vaccine in combination with plasmid interleukin 12 and impact of intramuscular electroporation for delivery.The Journal of infectious diseases · 2013Trial
- First-in-human evaluation of the safety and immunogenicity of a recombinant adenovirus serotype 26 HIV-1 Env vaccine (IPCAVD 001).The Journal of infectious diseases · 2013Trial
- Non-immunogenicity of overlapping gag peptides pulsed on autologous cells after vaccination of HIV infected individuals.PloS one · 2013Trial
- synDNA vaccine against TCR chains and neoantigens for T cell lymphoma therapy.Cancer immunology, immunotherapy : CII · 2026Article
- DNA-based immunotherapy for cancer: In vivo approaches for recalcitrant targets.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Review
- Synthetic DNA co-immunization with vaccine-aligned common consensus nucleoprotein and hemagglutinin protects mice against lethal influenza infection with a single immunization.Frontiers in immunology · 2025Article
- Advances in molecular adjuvants for nucleic acid vaccines.Frontiers in immunology · 2025Review
- Harnessing immunotherapeutic molecules and diagnostic biomarkers as human-derived adjuvants for MERS-CoV vaccine development.Frontiers in immunology · 2025Review
- DNA Vaccines: Their Formulations, Engineering and Delivery.Vaccines · 2024Review
- Safety and Immunogenicity of anVaccines · 2023Article
- Immunomodulation with IL-7 and IL-15 in HIV-1 infection.Journal of virus eradication · 2023Article
- Protective Immunity againstInternational journal of molecular sciences · 2023Article
- Advances in Infectious Disease Vaccine Adjuvants.Vaccines · 2022Review
14 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 12 institutions in 2 countries.
Funding
Abstract
backgroundDNA vaccines are a promising approach to vaccination since they circumvent the problem of vector-induced immunity. DNA plasmid cytokine adjuvants have been shown to augment immune responses in small animals and in macaques. METHODOLOGY/PRINCIPAL
findingsWe performed two first in human HIV vaccine trials in the US, Brazil and Thailand of an RNA-optimized truncated HIV-1 gag gene (p37) DNA derived from strain HXB2 administered either alone or in combination with dose-escalation of IL-12 or IL-15 plasmid cytokine adjuvants. Vaccinations with both the HIV immunogen and cytokine adjuvant were generally well-tolerated and no significant vaccine-related adverse events were identified. A small number of subjects developed asymptomatic low titer antibodies to IL-12 or IL-15. Cellular immunogenicity following 3 and 4 vaccinations was poor, with response rates to gag of 4.9%/8.7% among vaccinees receiving gag DNA alone, 0%/11.5% among those receiving gag DNA+IL-15, and no responders among those receiving DNA+high dose (1500 ug) IL-12 DNA. However, after three doses, 44.4% (4/9) of vaccinees receiving gag DNA and intermediate dose (500 ug) of IL-12 DNA demonstrated a detectable cellular immune response. CONCLUSIONS/SIGNIFICANCE: This combination of HIV gag DNA with plasmid cytokine adjuvants was well tolerated. There were minimal responses to HIV gag DNA alone, and no apparent augmentation with either IL-12 or IL-15 plasmid cytokine adjuvants. Despite the promise of DNA vaccines, newer formulations or methods of delivery will be required to increase their immunogenicity.
trial registrationClinicaltrials.gov NCT00115960 NCT00111605.
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.