ArticleTrials2018
A phase I, open-label trial on the safety and immunogenicity of the adjuvanted tuberculosis subunit vaccine H1/IC31® in people living in a TB-endemic area.
Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01049282 (A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine), which is not on this map. Cited by 22 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 Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered in Different Antigen/Adjuvant Formulations in TST Negative and TST Positive Volunteers at 0 and 2 Months
Who cites it
22 citing papers in PubMed, 27 citations in OpenAlex.
- Prophylactic and post-exposure efficacy of a Pichinde virus vector-based tuberculosis vaccine.Frontiers in immunology · 2026Article
- A proteome-wide atlas of humoral immunity toFrontiers in immunology · 2026Article
- Novel fusion protein REA induces robust prime protection against tuberculosis in mice.NPJ vaccines · 2025Article
- Tuberculosis vaccines and therapeutic drug: challenges and future directions.Molecular biomedicine · 2025Review
- Bioinformatics Analysis and Immunogenicity Assessment of the Novel Multi-Stage DNA Vaccine W541 Against Mycobacterium Tuberculosis.Immunity, inflammation and disease · 2024Article
- An intranasal nanoparticle vaccine elicits protective immunity against Mycobacterium tuberculosis.Vaccine · 2024Article
- Tuberculosis vaccine developments and efficient delivery systems: A comprehensive appraisal.Heliyon · 2024Review
- The role of ESAT-6 in tuberculosis immunopathology.Frontiers in immunology · 2024Review
- Challenges in Developing a Controlled Human Tuberculosis Challenge Model.Current topics in microbiology and immunology · 2024Review
- An Update on Tuberculosis Vaccines.Methods in molecular biology (Clifton, N.J.) · 2022Article
- Article
- Review
- Exploration of Pattern Recognition Receptor Agonists as Candidate Adjuvants.Frontiers in cellular and infection microbiology · 2021Review
- SARS-CoV-2 mRNA Vaccines Elicit Different Responses in Immunologically Naïve and Pre-Immune Humans.Frontiers in immunology · 2021Article
- Article
- Rescuing ESAT-6 Specific CD4 T Cells From Terminal Differentiation Is Critical for Long-Term Control of Murine Mtb Infection.Frontiers in immunology · 2020Article
- First-In-Human Trials of GamTBvac, a Recombinant Subunit Tuberculosis Vaccine Candidate: Safety and Immunogenicity Assessment.Vaccines · 2019Article
- Adjuvant Strategies for More Effective Tuberculosis Vaccine Immunity.Microorganisms · 2019Review
- Ensilication Improves the Thermal Stability of the Tuberculosis Antigen Ag85b and an Sbi-Ag85b Vaccine Conjugate.Scientific reports · 2019Article
- Progress in interferon-gamma release assay development and applications: an unfolding story of translational research.Annals of translational medicine · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 4 institutions in 5 countries.
Funding
Abstract
backgroundH1/IC31® is a tuberculosis (TB) subunit vaccine candidate consisting of the fusion protein of Ag85B and ESAT-6 (H1) formulated with the IC31® adjuvant. Previous trials have reported on the H1/IC31® vaccine in M. tuberculosis (Mtb)-naïve, BCG-vaccinated and previously Mtb-infected individuals. In this trial, conducted between December 2008 and April 2010, the safety and immunogenicity of H1/IC31® was assessed in participants living in Ethiopia - a highly TB-endemic area.
methodsHealthy male participants aged 18-25 years were recruited into four groups. Participants in group 1 (N = 12) and group 2 (N = 12) were Tuberculin Skin Test (TST) negative and QuantiFERON-TB Gold in-tube test (QFT) negative (Mtb-naïve groups), participants in group 3 (N = 3) were TST positive and QFT negative (BCG group), and participants in group 4 (N = 12) were both TST and QFT positive (Mtb-infected group). H1 vaccine alone (group 1) or H1 formulated with the adjuvant IC31® (groups 2, 3 and 4) was administered intramuscularly on day 0 and day 56. Safety and immunogenicity parameters were evaluated for up to 32 weeks after day 0.
resultsThe H1/IC31®vaccine was safe and generally well tolerated. There was little difference among the four groups, with a tendency towards a higher incidence of adverse events in Mtb-infected compared to Mtb-naïve participants. Two serious adverse events were reported in the Mtb-infected group where a relationship to the vaccine could not be excluded. In both cases the participants recovered without sequelae within 72 h. Immunogenicity assays, evaluated in the 29 participants who received both vaccinations, showed a stronger response to TB antigens in the Mtb-naïve group vaccinated with the adjuvant.
conclusionThe trial confirmed the need for an adjuvant for the vaccine to be immunogenic and highlighted the importance of early phase testing of a novel TB vaccine candidate in TB-endemic areas.
trial registrationClinicalTrials.gov, ID: NCT01049282. Retrospectively registered on 14 January 2010.
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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.