Trial reportPloS one2018
First-in-human randomized controlled trial of an oral, replicating adenovirus 26 vector vaccine for HIV-1.
Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02366013 (A Phase 1 Clinical Trial of the Safety and Immunogenicity of an Oral, Replicating Adenovirus 26 Vector Vaccine for HIV-1), which is not on this map. Cited by 23 papers.
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 1 Clinical Trial of the Safety and Immunogenicity of an Oral, Replicating Adenovirus 26 Vector Vaccine for HIV-1 (rcAd26.MOS1.HIV-Env) in Healthy HIV-1-uninfected Adults
Who cites it
23 citing papers in PubMed, 36 citations in OpenAlex.
- Safety and immunogenicity of Ad26 and MVA vaccines in acutely treated HIV and effect on viral rebound after antiretroviral therapy interruption.Nature medicine · 2020Trial
- Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025Review
- Health Technology Assessment of mRNA Vaccines: Clinical, Economic, and Public Health Implications.Vaccines · 2025Review
- Broad sialic acid usage amongst species D human adenovirus.Npj viruses · 2023Article
- The use of viral vectors in vaccine development.NPJ vaccines · 2022Review
- Viruses as tools in gene therapy, vaccine development, and cancer treatment.Archives of virology · 2022Review
- Drop the Needle; A Temperature Stable Oral Tablet Vaccine Is Protective against Respiratory Viral Pathogens.Vaccines · 2022Review
- Current GMP standards for the production of vaccines and antibodies: An overview.Frontiers in public health · 2022Review
- Virus-based vaccine vectors with distinct replication mechanisms differentially infect and activate dendritic cells.NPJ vaccines · 2021Article
- Review
- The immunological impact of adenovirus early genes on vaccine-induced responses in mice and nonhuman primates.Journal of virology · 2021Article
- Adenovirus-vectored vaccine containing multidimensionally conserved parts of the HIV proteome is immunogenic in rhesus macaques.Proceedings of the National Academy of Sciences of the United States of America · 2021Article
- Recent Advances in the Development of Exogenous dsRNA for the Induction of RNA Interference in Cancer Therapy.Molecules (Basel, Switzerland) · 2021Review
- Evaluation of Direct and Cell-Mediated Lactoferrin Gene Therapy for the Maxillofacial Area Abscesses in Rats.Pharmaceutics · 2021Article
- Advances in Oral Subunit Vaccine Design.Vaccines · 2020Review
- COVID-19 Vaccines: "Warp Speed" Needs Mind Melds, Not Warped Minds.Journal of virology · 2020Review
- CD8Nature reviews. Immunology · 2020Review
- Targeting Antigen to the Surface of EVs Improves theMolecular therapy. Methods & clinical development · 2020Article
- TFrontiers in immunology · 2020Article
- A Mucosal Adenovirus Prime/Systemic Envelope Boost Vaccine Regimen Elicits Responses in Cervicovaginal and Alveolar Macrophages of Rhesus Macaques Associated With Delayed SIV Acquisition and B Cell Help.Frontiers in immunology · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 4 institutions in 2 countries.
Funding
Abstract
backgroundLive, attenuated viral vectors that express HIV-1 antigens are being investigated as an approach to generating durable immune responses against HIV-1 in humans. We recently developed a replication-competent, highly attenuated Ad26 vector that expresses mosaic HIV-1 Env (rcAd26.MOS1.HIV-Env, "rcAd26"). Here we present the results of a first-in-human, placebo-controlled clinical trial to test the safety, immunogenicity and mucosal shedding of rcAd26 given orally.
methodsHealthy adults were randomly assigned to receive a single oral dose of vaccine or placebo at 5:1 ratio in a dosage escalation of 10^8 to 10^11 rcAd26 VP (nominal doses) at University of Rochester Medical Center, Rochester, NY, USA. Participants were isolated and monitored for reactogenicity for 10 days post-vaccination, and adverse events were recorded up to day 112. Rectal and oropharyngeal secretions were evaluated for shedding of the vaccine. Humoral and cellular immune responses were measured. Household contacts were monitored for secondary vaccine transmission.
resultsWe enrolled 22 participants and 11 household contacts between February 7 and June 24, 2015. 18 participants received one dose of HIV-1 vaccine and 4 participants received placebo. The vaccine caused only mild to moderate adverse events. No vaccine-related SAEs were observed. No infectious rcAd26 viral particles were detected in rectal or oropharyngeal secretions from any participant. Env-specific ELISA and ELISPOT responses were undetectable. No household contacts developed vaccine-induced HIV-1 seropositivity or vaccine-associated illness.
conclusionsThe highly attenuated rcAd26.MOS1.HIV-Env vaccine was well tolerated up to 10^11 VP in healthy, HIV-1-uninfected adults, though the single dose was poorly immunogenic suggesting the replicative capacity of the vector was too attenuated. There was no evidence of shedding of infectious virus or secondary vaccine transmission following the isolation period. These data suggest the use of less attenuated viral vectors in future studies of live, oral HIV-1 vaccines.
trial registrationClinicalTrials.gov NCT02366013.
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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.