Trial reportPloS one2011
Phase I randomised clinical trial of an HIV-1(CN54), clade C, trimeric envelope vaccine candidate delivered vaginally.
Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00637962 (Phase I Clinical Trial in Healthy Female Volunteers of Reactogenicity and Immunogenicity of Nine Vaginal Immunisations With HIV CN54gp140 Glycoprotein), which is not on this map. Cited by 37 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.
Phase I Clinical Trial in Healthy Female Volunteers of Reactogenicity and Immunogenicity of Nine Vaginal Immunisations With HIV CN54gp140 Glycoprotein
Who cites it
37 citing papers in PubMed, 52 citations in OpenAlex.
- Trial
- Combined skin and muscle vaccination differentially impact the quality of effector T cell functions: the CUTHIVAC-001 randomized trial.Scientific reports · 2017Trial
- Trial
- MABGEL 1: first phase 1 trial of the anti-HIV-1 monoclonal antibodies 2F5, 4E10 and 2G12 as a vaginal microbicide.PloS one · 2014Trial
- Trial
- Systemic and mucosal immune responses to sublingual or intramuscular human papilloma virus antigens in healthy female volunteers.PloS one · 2012Trial
- Novel HIV-1 fusion peptide immunogens using glycan-engineered alphavirus-like particles.NPJ vaccines · 2025Article
- Recent Advancements in Non-Invasive Vaccination Strategies.Vaccines · 2025Review
- Mucosal vaccine delivery: A focus on the breakthrough of specific barriers.Acta pharmaceutica Sinica. B · 2022Review
- Towards the future exploration of mucosal mRNA vaccines against emerging viral diseases; lessons from existing next-generation mucosal vaccine strategies.NPJ vaccines · 2022Review
- Systematic comparison of HIV-1 Envelope-specific IgG responses induced by different vaccination regimens: Can we steer IgG recognition towards regions of viral vulnerability?Frontiers in immunology · 2022Article
- Vaginal delivery of vaccines.Advanced drug delivery reviews · 2021Review
- Protein and Glycan Mimicry in HIV Vaccine Design.Journal of molecular biology · 2019Review
- Mucosal Vaccine Approaches for Prevention of HIV and SIV Transmission.Current immunology reviews · 2019Article
- Modulation of Antibody Responses to the V1V2 and V3 Regions of HIV-1 Envelope by Immune Complex Vaccines.Frontiers in immunology · 2018Article
- Intravaginal immunisation using a novel antigen-releasing ring device elicits robust vaccine antigen-specific systemic and mucosal humoral immune responses.Journal of controlled release : official journal of the Controlled Release Society · 2017Article
- Immunoglobulin G1 Allotype Influences Antibody Subclass Distribution in Response to HIV gp140 Vaccination.Frontiers in immunology · 2017Article
- Native-like Env trimers as a platform for HIV-1 vaccine design.Immunological reviews · 2017Review
- A Phase 1 Human Immunodeficiency Virus Vaccine Trial for Cross-Profiling the Kinetics of Serum and Mucosal Antibody Responses to CN54gp140 Modulated by Two Homologous Prime-Boost Vaccine Regimens.Frontiers in immunology · 2017Article
- A Comparative Phase I Study of Combination, Homologous Subtype-C DNA, MVA, and Env gp140 Protein/Adjuvant HIV Vaccines in Two Immunization Regimes.Frontiers in immunology · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 4 institutions in 1 country.
Funding
Abstract
unlabelledWe conducted a phase 1 double-blind randomised controlled trial (RCT) of a HIV-1 envelope protein (CN54 gp140) candidate vaccine delivered vaginally to assess immunogenicity and safety. It was hypothesised that repeated delivery of gp140 may facilitate antigen uptake and presentation at this mucosal surface. Twenty two healthy female volunteers aged 18-45 years were entered into the trial, the first receiving open-label active product. Subsequently, 16 women were randomised to receive 9 doses of 100 µg of gp140 in 3 ml of a Carbopol 974P based gel, 5 were randomised to placebo solution in the same gel, delivered vaginally via an applicator. Participants delivered the vaccine three times a week over three weeks during one menstrual cycle, and were followed up for two further months. There were no serious adverse events, and the vaccine was well tolerated. No sustained systemic or local IgG, IgA, or T cell responses to the gp140 were detected following vaginal immunisations. Repeated vaginal immunisation with a HIV-1 envelope protein alone formulated in Carbopol gel was safe, but did not induce local or systemic immune responses in healthy women.
trial registrationClinicalTrials.gov NCT00637962.
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.