ArticleEClinicalMedicine2020
A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in
Article in EClinicalMedicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 1 of them a synthesis that pooled it.
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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
50 citing papers in PubMed, 1 synthesis or guideline pooled it, 73 citations in OpenAlex.
- A systematic review on malaria and Tuberculosis (TB) vaccine challenges in sub-Saharan African clinical trials.PloS one · 2025Pooled it
- Probing Dermal Immunity to Mycobacteria through a Controlled Human Infection Model.ImmunoHorizons · 2024Trial
- A Phase I/II randomized trial of H56:IC31 vaccination and adjunctive cyclooxygenase-2-inhibitor treatment in tuberculosis patients.Nature communications · 2021Trial
- Revisiting the Chingleput BCG vaccination trial for the impact of BCG revaccination on the incidence of tuberculosis disease.The Indian journal of medical researchTrial
- Screening and in silico evaluation of candidate late-stage antigens for incorporation into multi-stage and post-exposure vaccines against tuberculosis.NPJ vaccines · 2026Review
- A proteome-wide atlas of humoral immunity toFrontiers in immunology · 2026Article
- Protective Effect and Immune Mechanism of EPCP009 Booster Immunization after BCG Prime Immunization Against Tuberculosis in Mice - China, 2024.China CDC weekly · 2025Article
- Article
- Characterizing TLR4 agonist EmT4™ as an anti-Mycobacterium tuberculosis vaccine adjuvant.ImmunoHorizons · 2025Article
- Tuberculosis vaccines and therapeutic drug: challenges and future directions.Molecular biomedicine · 2025Review
- A multi-epitope vaccine incorporating adhesin-derived antigens protects againstFrontiers in immunology · 2025Article
- BCG and beyond: unlocking new frontiers in TB vaccine development.Frontiers in immunology · 2025Review
- Bioinformatics Analysis and Immunogenicity Assessment of the Novel Multi-Stage DNA Vaccine W541 Against Mycobacterium Tuberculosis.Immunity, inflammation and disease · 2024Article
- Adolescent BCG revaccination induces a phenotypic shift in CD4Nature communications · 2024Article
- Bacillus Calmette-Guérin (BCG) Revaccination and Protection Against Tuberculosis: A Systematic Review.Cureus · 2024Review
- Tuberculosis vaccine developments and efficient delivery systems: A comprehensive appraisal.Heliyon · 2024Review
- Whole blood RNA signatures in tuberculosis patients receiving H56:IC31 vaccine as adjunctive therapy.Frontiers in immunology · 2024Article
- The role of ESAT-6 in tuberculosis immunopathology.Frontiers in immunology · 2024Review
- Review
- Article
Corrections and comments
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Authors and funding
22 authors at 7 institutions in 4 countries.
Funding
Abstract
backgroundTuberculosis (TB) remains the leading cause of infectious disease-related death. Recently, a trial of BCG revaccination and vaccination with H4:IC31, a recombinant protein vaccine, in South African adolescents (Aeras C-040-404) showed efficacy in preventing sustained QuantiFERON (QFT) conversion, a proxy for
methodsTwo doses of H4:IC31 and H56:IC31 vaccines were administered intramuscularly (IM) 56 days apart, and a single dose of BCG (2-8 × 10
findingsIn total, 481 adolescents (mean age 13·9 years) were screened; 84 were enrolled (54% female). The vaccines were generally safe and well-tolerated, with no reported severe adverse events related to the study vaccines. H4:IC31 and H56:IC31 elicited CD4+ T cells recognizing vaccine-matched antigens and H4- and H56-specific IgG binding antibodies. The highest vaccine-induced CD4+ T-cell response rates were for those recognizing Ag85B in the H4:IC31 and H56:IC31 vaccinated groups. BCG revaccination elicited robust, polyfunctional BCG-specific CD4+ T cells, with no increase in H4- or H56-specific IgG binding antibodies. There were few antigen-specific CD8+ T-cell responses detected in any group.
interpretationBCG revaccination administered as a single dose ID and both H4:IC31 and H56:IC31 administered as 2 doses IM had acceptable safety profiles in healthy, QFT-negative, previously BCG-vaccinated adolescents. Characterization of the assays and the immunogenicity of these vaccines may help to identify valuable markers of protection for upcoming immune correlates analyses of C-040-404 and future TB vaccine efficacy trials.
fundingNIAID and Aeras.
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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.