Trial reportPloS one2010
Safety and immunogenicity of a replication-defective adenovirus type 5 HIV vaccine in Ad5-seronegative persons: a randomized clinical trial (HVTN 054).
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 trial NCT00119873 (A Phase I Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade, Multivalent Recombinant Adenoviral Vector HIV Vaccine, VRC-HIVADV014-00-VP, in Healthy, HIV-1 Uninfected Adult Participants Who Have Low Titers of Pre-Existing Ad5 Neutralizing Antibodies), which is not on this map. Cited by 37 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 Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade, Multivalent Recombinant Adenoviral Vector HIV Vaccine, VRC-HIVADV014-00-VP, in Healthy, HIV-1 Uninfected Adult Participants Who Have Low Titers of Pre-Existing Ad5 Neutralizing Antibodies
Who cites it
37 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 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
- Antigenic competition in CD4Science translational medicine · 2019Trial
- Safety and Immunogenicity of a rAd35-EnvA Prototype HIV-1 Vaccine in Combination with rAd5-EnvA in Healthy Adults (VRC 012).PloS one · 2016Trial
- HIV-1-Specific Antibody Response and Function after DNA Prime and Recombinant Adenovirus 5 Boost HIV Vaccine in HIV-Infected Subjects.PloS one · 2016Trial
- Trial
- HIV-specific humoral responses benefit from stronger prime in phase Ib clinical trial.The Journal of clinical investigation · 2014Trial
- Recombinant adenovirus type 5 HIV gag/pol/nef vaccine in South Africa: unblinded, long-term follow-up of the phase 2b HVTN 503/Phambili study.The Lancet. Infectious diseases · 2014Trial
- Immunogenicity of ALVAC-HIV vCP1521 in infants of HIV-1-infected women in Uganda (HPTN 027): the first pediatric HIV vaccine trial in Africa.Journal of acquired immune deficiency syndromes (1999) · 2014Trial
- Trial
- Trial
- Randomized, placebo-controlled trial to assess the safety and immunogenicity of an adenovirus type 35-based circumsporozoite malaria vaccine in healthy adults.Human vaccines & immunotherapeutics · 2013Trial
- Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine.The New England journal of medicine · 2013Trial
- HIV-1 vaccine-induced T-cell responses cluster in epitope hotspots that differ from those induced in natural infection with HIV-1.PLoS pathogens · 2013Trial
- Trial
- HIV-DNA priming alters T cell responses to HIV-adenovirus vaccine even when responses to DNA are undetectable.Journal of immunology (Baltimore, Md. : 1950) · 2011Trial
- Trial
- Article
- Article
- Safety and immunogenicity of the ChAdOx1-MVA-vectored conserved mosaic HIVconsvX candidate T-cell vaccines in HIV-CORE 005.2, an open-label, dose-escalation, first-in-human, phase 1 trial in adults living without HIV-1 in the UK.The Lancet. Microbe · 2025Article
- 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
10 authors at 6 institutions in 1 country.
Funding
Abstract
backgroundIndividuals without prior immunity to a vaccine vector may be more sensitive to reactions following injection, but may also show optimal immune responses to vaccine antigens. To assess safety and maximal tolerated dose of an adenoviral vaccine vector in volunteers without prior immunity, we evaluated a recombinant replication-defective adenovirus type 5 (rAd5) vaccine expressing HIV-1 Gag, Pol, and multiclade Env proteins, VRC-HIVADV014-00-VP, in a randomized, double-blind, dose-escalation, multicenter trial (HVTN study 054) in HIV-1-seronegative participants without detectable neutralizing antibodies (nAb) to the vector. As secondary outcomes, we also assessed T-cell and antibody responses. METHODOLOGY/PRINCIPAL
findingsVolunteers received one dose of vaccine at either 10(10) or 10(11) adenovector particle units, or placebo. T-cell responses were measured against pools of global potential T-cell epitope peptides. HIV-1 binding and neutralizing antibodies were assessed. Systemic reactogenicity was greater at the higher dose, but the vaccine was well tolerated at both doses. Although no HIV infections occurred, commercial diagnostic assays were positive in 87% of vaccinees one year after vaccination. More than 85% of vaccinees developed HIV-1-specific T-cell responses detected by IFN-γ ELISpot and ICS assays at day 28. T-cell responses were: CD8-biased; evenly distributed across the three HIV-1 antigens; not substantially increased at the higher dose; and detected at similar frequencies one year following injection. The vaccine induced binding antibodies against at least one HIV-1 Env antigen in all recipients. CONCLUSIONS/SIGNIFICANCE: This vaccine appeared safe and was highly immunogenic following a single dose in human volunteers without prior nAb against the vector.
trial registrationClinicalTrials.gov NCT00119873.
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.