Trial reportThe Journal of infectious diseases2008
A new recombinant bacille Calmette-Guérin vaccine safely induces significantly enhanced tuberculosis-specific immunity in human volunteers.
Trial report in The Journal of infectious diseases, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 79 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
79 citing papers in PubMed, 1 synthesis or guideline pooled it, 178 citations in OpenAlex.
- Vaccine against tuberculosis: what's new?BMC infectious diseases · 2014Pooled it
- Rapamycin enhances BCG-specific γδ T cells during intravesical BCG therapy for non-muscle invasive bladder cancer: a randomized, double-blind study.Journal for immunotherapy of cancer · 2021Trial
- Safety and Immunogenicity of the Recombinant BCG Vaccine AERAS-422 in Healthy BCG-naïve Adults: A Randomized, Active-controlled, First-in-human Phase 1 Trial.EBioMedicine · 2016Trial
- Trial
- Immunogenicity of a protective whole cell mycobacterial vaccine in HIV-infected adults: a phase III study in Tanzania.Vaccine · 2010Trial
- Article
- Unleashing the power of the BCG vaccine in modulating viral immunity through heterologous protection: A scoping review.Human vaccines & immunotherapeutics · 2025Article
- IFN-γ-Driven macrophage responses in the immunity toFrontiers in cellular and infection microbiology · 2025Review
- Assays for AssessingPathogens (Basel, Switzerland) · 2024Article
- Enhanced Effects of ISA 207 Adjuvant via Intradermal Route in Foot-and-Mouth Disease Vaccine for Pigs.Vaccines · 2024Article
- The BCG vaccine, advantages, and disadvantages of introducing new generation vaccines againstClinical and experimental vaccine research · 2024Review
- Article
- Microneedle-Mediated Immunization Promotes Lung CD8+ T-Cell Immunity.The Journal of investigative dermatology · 2023Article
- The Induction of Antigen 85B-Specific CD8International journal of molecular sciences · 2023Article
- Recent advance in the development of tuberculosis vaccines in clinical trials and virus-like particle-based vaccine candidates.Frontiers in immunology · 2023Review
- Recent Developments in Mycobacteria-Based Live Attenuated Vaccine Candidates for Tuberculosis.Biomedicines · 2022Review
- Article
- It Takes a Village: The Multifaceted Immune Response toFrontiers in immunology · 2022Review
- Pathological and protective roles of dendritic cells inFrontiers in cellular and infection microbiology · 2022Review
- Peptide-Based Vaccines for Tuberculosis.Frontiers in immunology · 2022Review
19 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 2 countries.
Funding
Abstract
backgroundOne strategy for improving anti-tuberculosis (TB) vaccination involves the use of recombinant bacille Calmette-Guérin (rBCG) overexpressing protective TB antigens. rBCG30, which overexpresses the Mycobacterium tuberculosis secreted antigen Ag85b, was the first rBCG shown to induce significantly greater protection against TB in animals than parental BCG.
methodsWe report here the first double-blind phase 1 trial of rBCG30 in 35 adults randomized to receive either rBCG30 or parental Tice BCG intradermally. Clinical reactogenicity was assessed, and state-of-the-art immunological assays were used to study Ag85b-specific immune responses induced by both vaccines.
resultsSimilar clinical reactogenicity occurred with both vaccines. rBCG30 induced significantly increased Ag85b-specific T cell lymphoproliferation, interferon (IFN)-gamma secretion, IFN-gamma enzyme-linked immunospot responses, and direct ex vivo intracellular IFN-gamma responses. Additional flow cytometry studies measuring carboxyfluorescein succinimidyl ester dilution and intracellular cytokine production demonstrated that rBCG30 significantly enhanced the population of Ag85b-specific CD4(+) and CD8(+) T cells capable of concurrent expansion and effector function. More importantly, rBCG30 significantly increased the number of Ag85b-specific T cells capable of inhibiting intracellular mycobacteria.
conclusionsThese results provide proof of principal that rBCG can safely enhance human TB immunity and support further development of rBCG overexpressing Ag85b for TB vaccination.
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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.