Trial reportPloS one2014
Phase I randomized clinical trial of VRC DNA and rAd5 HIV-1 vaccine delivery by intramuscular (i.m.), subcutaneous (s.c.) and intradermal (i.d.) administration (VRC 011).
Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00321061 (VRC 011), which is not on this map. Cited by 15 papers.
What it found
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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 011: A Phase I Clinical Trial of Intramuscular, Subcutaneous and Intradermal Administration of an HIV-1 Multiclade DNA Vaccine, VRC-HIVDNA016-00-VP, and an HIV-1 Multiclade Adenoviral Vector Vaccine,VRC-HIVADV014-00-VP, in Uninfected Adult Volunteers
Who cites it
15 citing papers in PubMed.
- Safety and immunogenicity of the therapeutic vaccine TG1050 in chronic hepatitis B patients: a phase 1b placebo-controlled trial.Human vaccines & immunotherapeutics · 2020Trial
- Safety and Immunogenicity of a rAd35-EnvA Prototype HIV-1 Vaccine in Combination with rAd5-EnvA in Healthy Adults (VRC 012).PloS one · 2016Trial
- Induction of HIV-1-specific antibody-mediated effector functions by native-like envelope trimers in humans.PLoS pathogens · 2025Article
- Vaccine delivery systems and administration routes: Advanced biotechnological techniques to improve the immunization efficacy.Vaccine: X · 2024Review
- Effectiveness and safety of tetanus vaccine administration by intramuscular vs. subcutaneous route in anticoagulated patients: Randomized clinical trial in primary care.Frontiers in medicine · 2022Article
- Nanovaccine Delivery Approaches and Advanced Delivery Systems for the Prevention of Viral Infections: From Development to Clinical Application.Pharmaceutics · 2021Review
- Subcutaneous vaccine administration - an outmoded practice.Human vaccines & immunotherapeutics · 2021Review
- Advances in gene-based vaccine platforms to address the COVID-19 pandemic.Advanced drug delivery reviews · 2021Review
- Article
- Protective effect of a polyvalent influenza DNA vaccine in pigs.Veterinary immunology and immunopathology · 2018Article
- A Plasmodium vivax Plasmid DNA- and Adenovirus-Vectored Malaria Vaccine Encoding Blood-Stage Antigens AMA1 and MSP1Clinical and vaccine immunology : CVI · 2017Article
- An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1.Human vaccines & immunotherapeutics · 2016Article
- Analysis of T cell responses to chimpanzee adenovirus vectors encoding HIV gag-pol-nef antigen.Vaccine · 2015Article
- A Comparison of Red Fluorescent Proteins to Model DNA Vaccine Expression by Whole Animal In Vivo Imaging.PloS one · 2015Article
- Effect of vaccine administration modality on immunogenicity and efficacy.Expert review of vaccines · 2015Review
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.
Funding
Abstract
backgroundPhase 1 evaluation of the VRC HIV DNA and rAd5 vaccines delivered intramuscularly (i.m.) supported proceeding to a Phase 2 b efficacy study. Here we report comparison of the i.m., subcutaneous (s.c.) and intradermal (i.d.) routes of administration.
methodsSixty subjects were randomized to 6 schedules to evaluate the i.m., s.c. or i.d. route for prime injections. Three schedules included DNA primes (Wks 0,4,8) and 3 schedules included rAd5 prime (Wk0); all included rAd5 i.m. boost (Wk24). DNA vaccine dosage was 4 mg i.m. or s.c., but 0.4 mg i.d., while all rAd5 vaccinations were 1010 PU. All injections were administered by needle and syringe.
resultsOverall, 27/30 subjects completed 3 DNA primes; 30/30 subjects completed rAd5 primes. Mild local pruritus (itchiness), superficial skin lesions and injection site nodules were associated with i.d. and s.c., but not i.m. injections. All routes induced T-cell and antibody immune responses after rAd5 boosting. Overall, >95% had Env antibody and >80% had Env T-cell responses.
conclusionsThe pattern of local reactogenicity following i.d. and s.c. injections differed from i.m. injections but all routes were well-tolerated. There was no evidence of an immunogenicity advantage following s.c. or i.d. delivery, supporting i.m. delivery as the preferred route of administration.
trial registrationClinicaltrials.gov NCT00321061.
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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.