Trial reportPloS one2014
Safety and immunogenicity of H1/IC31®, an adjuvanted TB subunit vaccine, in HIV-infected adults with CD4+ lymphocyte counts greater than 350 cells/mm3: a phase II, multi-centre, double-blind, randomized, placebo-controlled trial.
Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
33 citing papers in PubMed, 58 citations in OpenAlex.
- Antiviral Innate Immune Activation in HIV-Infected Adults Negatively Affects H1/IC31-Induced Vaccine-Specific Memory CD4+ T Cells.Clinical and vaccine immunology : CVI · 2015Trial
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- Tuberculosis vaccine developments and efficient delivery systems: A comprehensive appraisal.Heliyon · 2024Review
- Importance of adjuvant selection in tuberculosis vaccine development: Exploring basic mechanisms and clinical implications.Vaccine: X · 2023Review
- Immunomodulatory nanosystems: An emerging strategy to combat viral infections.Biomaterials and biosystems · 2023Review
- Developing tuberculosis vaccines for people with HIV: consensus statements from an international expert panel.The lancet. HIV · 2022Review
- An Update on Tuberculosis Vaccines.Methods in molecular biology (Clifton, N.J.) · 2022Article
- A review of the BCG vaccine and other approaches toward tuberculosis eradication.Human vaccines & immunotherapeutics · 2021Review
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- Vaccine strategies for theNPJ vaccines · 2020Review
- Dose finding for new vaccines: The role for immunostimulation/immunodynamic modelling.Journal of theoretical biology · 2019Article
- The current status, challenges, and future developments of new tuberculosis vaccines.Human vaccines & immunotherapeutics · 2018Review
- Development of New Preventive and Therapeutic Vaccines for Tuberculosis.Immune network · 2018Review
- Identification of protective postexposure mycobacterial vaccine antigens using an immunosuppression-based reactivation model in the zebrafish.Disease models & mechanisms · 2018Article
- Article
- Vaccines for Leprosy and Tuberculosis: Opportunities for Shared Research, Development, and Application.Frontiers in immunology · 2018Review
- Using vaccine Immunostimulation/Immunodynamic modelling methods to inform vaccine dose decision-making.NPJ vaccines · 2018Article
- Application of Pharmacokinetics Modelling to Predict Human Exposure of a Cationic Liposomal Subunit Antigen Vaccine System.Pharmaceutics · 2017Article
Corrections and comments
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Authors and funding
20 authors at 7 institutions in 5 countries.
Funding
Abstract
backgroundNovel tuberculosis vaccines should be safe, immunogenic, and effective in various population groups, including HIV-infected individuals. In this phase II multi-centre, double-blind, placebo-controlled trial, the safety and immunogenicity of the novel H1/IC31 vaccine, a fusion protein of Ag85B-ESAT-6 (H1) formulated with the adjuvant IC31, was evaluated in HIV-infected adults.
methodsHIV-infected adults with CD4+ T cell counts >350/mm3 and without evidence of active tuberculosis were enrolled and followed until day 182. H1/IC31 vaccine or placebo was randomly allocated in a 5:1 ratio. The vaccine was administered intramuscularly at day 0 and 56. Safety assessment was based on medical history, clinical examinations, and blood and urine testing. Immunogenicity was determined by a short-term whole blood intracellular cytokine staining assay.
results47 of the 48 randomised participants completed both vaccinations. In total, 459 mild or moderate and 2 severe adverse events were reported. There were three serious adverse events in two vaccinees classified as not related to the investigational product. Local injection site reactions were more common in H1/IC31 versus placebo recipients (65.0% vs. 12.5%, p = 0.015). Solicited systemic and unsolicited adverse events were similar by study arm. The baseline CD4+ T cell count and HIV viral load were similar by study arm and remained constant over time. The H1/IC31 vaccine induced a persistent Th1-immune response with predominately TNF-α and IL-2 co-expressing CD4+ T cells, as well as polyfunctional IFN-γ, TNF-α and IL-2 expressing CD4+ T cells.
conclusionH1/IC31 was well tolerated and safe in HIV-infected adults with a CD4+ Lymphocyte count greater than 350 cells/mm3. The vaccine did not have an effect on CD4+ T cell count or HIV-1 viral load. H1/IC31 induced a specific and durable Th1 immune response.
trial registrationPan African Clinical Trials Registry (PACTR) PACTR201105000289276.
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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.