Trial reportThe Journal of infectious diseases2015
Induction of HIV-1-specific mucosal immune responses following intramuscular recombinant adenovirus serotype 26 HIV-1 vaccination of humans.
Trial report in The Journal of infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01103687 (A Phase 1 Randomized, Double-Blind, Placebo Controlled Clinical Trial to Evaluate the Safety, Mucosal Immunogenicity and Innate Immune Responses of Recombinant Adenovirus Serotype 26 HIV-1 Vaccine), which is not on this map. Cited by 48 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.
A Phase 1 Randomized, Double-Blind, Placebo Controlled Clinical Trial to Evaluate the Safety, Mucosal Immunogenicity and Innate Immune Responses of Recombinant Adenovirus Serotype 26 HIV-1 Vaccine (Ad26.ENVA.01) in Healthy, HIV-1 Uninfected Adults (Ad26.ENVA.01 (rAd26) HIV-1 Mucosal/IPCAVD-003 Vaccine Study)
Who cites it
48 citing papers in PubMed, 64 citations in OpenAlex.
- Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study.The lancet. HIV · 2020Trial
- Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19).Lancet (London, England) · 2018Trial
- First-in-Human Randomized, Controlled Trial of Mosaic HIV-1 Immunogens Delivered via a Modified Vaccinia Ankara Vector.The Journal of infectious diseases · 2018Trial
- First-in-human randomized controlled trial of an oral, replicating adenovirus 26 vector vaccine for HIV-1.PloS one · 2018Trial
- Safety and Immunogenicity of a rAd35-EnvA Prototype HIV-1 Vaccine in Combination with rAd5-EnvA in Healthy Adults (VRC 012).PloS one · 2016Trial
- Trial
- The role of naturally occurring and vaccine-induced Ad26 neutralizing antibodies in immunogenicity of Ad26-based vaccines.NPJ vaccines · 2026Article
- Article
- Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025Review
- Review
- Evolving Horizons: Adenovirus Vectors' Timeless Influence on Cancer, Gene Therapy and Vaccines.Viruses · 2023Review
- Activation of coagulation and proinflammatory pathways in thrombosis with thrombocytopenia syndrome and following COVID-19 vaccination.Nature communications · 2023Article
- Sequential use of Ad26-based vaccine regimens in NHP to induce immunity against different disease targets.NPJ vaccines · 2022Article
- Seroprevalence of neutralizing antibodies against adenovirus type 26 and 35 in healthy populations from Guangdong and Shandong provinces, China.Virologica Sinica · 2022Article
- Adenovirus vector-based vaccine for infectious diseases.Drug metabolism and pharmacokinetics · 2022Review
- The use of adenoviral vectors in gene therapy and vaccine approaches.Genetics and molecular biology · 2022Article
- Rapid and inexpensive purification of adenovirus vectors using an optimised aqueous two-phase technology.Journal of virological methods · 2022Article
- Review
- Evidence of a tolerogenic vaccine against AIDS in the Chinese macaque prefigures a potential human vaccine.Archives of virology · 2021Review
- Meta-analysis of HIV-1 vaccine elicited mucosal antibodies in humans.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
24 authors at 6 institutions in 2 countries.
Funding
Abstract
backgroundDefining mucosal immune responses and inflammation to candidate human immunodeficiency virus type 1 (HIV-1) vaccines represents a current research priority for the HIV-1 vaccine field. In particular, it is unclear whether intramuscular immunization can elicit immune responses at mucosal surfaces in humans.
methodsIn this double-blind, randomized, placebo-controlled clinical trial, we evaluated systemic and mucosal immune responses to a candidate adenovirus serotype 26 (Ad26) vectored HIV-1 envelop (Env) vaccine in baseline Ad26-seronegative and Ad26-seropositive healthy volunteers. Systematic mucosal sampling with rectal Weck-Cel sponges and rectal biopsies were performed.
resultsIntramuscular immunization elicited both systemic and mucosal Env-specific humoral and cellular immune responses in the majority of subjects. Individuals with preexisting Ad26-specific neutralizing antibodies had vaccine-elicited immune responses comparable to those of subjects who were Ad26 seronegative. We also observed no increase in activated total or vector-specific mucosal CD4+ T lymphocytes following vaccination by either histopathology or flow cytometry.
conclusionsThese data demonstrate that a single intramuscular administration of this Ad26-vectored HIV-1 Env vaccine elicited both systemic and mucosal immune responses in humans. Induction of antigen-specific humoral and cellular mucosal immunity was not accompanied by a detectable increase in mucosal inflammation. CLINICAL TRIALS REGISTRATION: NCT01103687.
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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.