Trial reportPloS one2013
DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial.
Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00109629 (VRC 008), which is not on this map. Cited by 46 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.
VRC 008: A Phase I Clinical Trial of a Prime-Boost HIV-1 Vaccination Schedule: Multiclade DNA Vaccine, VRC-HIVDNA016-00-VP, Followed by Multiclade Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in Uninfected Adult Volunteers
Who cites it
46 citing papers in PubMed, 1 synthesis or guideline pooled it, 83 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
- Phase 1 Human Immunodeficiency Virus (HIV) Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Subtype C DNA and MF59-Adjuvanted Subtype C Envelope Protein.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Antibody and cellular responses to HIV vaccine regimens with DNA plasmid as compared with ALVAC priming: An analysis of two randomized controlled trials.PLoS medicine · 2020Trial
- Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials.Lancet (London, England) · 2018Trial
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- Needle-Free Injection Enhances the Immunogenicity and Antitumor Efficacy of Whole-Cell Tumor Vaccines.Vaccines · 2026Article
- Micro-needle jet injection technology for tunable drug dispersion at delivery.Drug delivery and translational research · 2026Article
- The Role of the CLIC/GEEC Endocytic Pathway for Mechanophysical Transfection of DNA.The journal of gene medicine · 2025Review
- From genetic code to global health: the impact of nucleic acid vaccines on disease prevention and treatment.RSC medicinal chemistry · 2025Review
- Article
- Nucleic acid vaccines: innovations, efficacy, and applications in at-risk populations.Frontiers in immunology · 2025Review
- New insights for the development of efficient DNA vaccines.Microbial biotechnology · 2024Review
- Immunogenic Comparison of Nucleic Acid-Based Vaccines Administered by Pyro-Drive Jet Injector.Vaccines · 2024Article
- Article
- Review
- Article
- Article
- Preclinical evaluation of a candidate naked plasmid DNA vaccine against SARS-CoV-2.NPJ vaccines · 2021Article
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 3 institutions in 1 country.
Funding
Abstract
backgroundDNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO2-powered Biojector® device was compared to delivery by needle and syringe and evaluated for safety and immunogenicity.
methodsForty adults, 18-50 years, were randomly assigned to intramuscular (IM) vaccinations with DNA vaccine, VRC-HIVDNA016-00-VP, (weeks 0, 4, 8) by Biojector® 2000™ or needle and syringe (N/S) and boosted IM at week 24 with VRC-HIVADV014-00-VP (rAd5) with N/S at 10(10) or 10(11) particle units (PU). Equal numbers per assigned schedule had low (≤500) or high (>500) reciprocal titers of preexisting Ad5 neutralizing antibody.
results120 DNA and 39 rAd5 injections were given; 36 subjects completed follow-up research sample collections. IFN-γ ELISpot response rates were 17/19 (89%) for Biojector® and 13/17 (76%) for N/S delivery at Week 28 (4 weeks post rAd5 boost). The magnitude of ELISpot response was about 3-fold higher in Biojector® compared to N/S groups. Similar effects on response rates and magnitude were observed for CD8+, but not CD4+ T-cell responses by ICS. Env-specific antibody responses were about 10-fold higher in Biojector-primed subjects.
conclusionsDNA vaccination by Biojector® was well-tolerated and compared to needle injection, primed for greater IFN-γ ELISpot, CD8+ T-cell, and antibody responses after rAd5 boosting.
trial registrationClinicalTrials.gov NCT00109629.
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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.