Trial reportClinical and vaccine immunology : CVI2016
Safety of Recombinant Fusion Protein ESAT6-CFP10 as a Skin Test Reagent for Tuberculosis Diagnosis: an Open-Label, Randomized, Single-Center Phase I Clinical Trial.
Trial report in Clinical and vaccine immunology : CVI, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01999231 (Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10), which is not on this map. Cited by 11 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.
Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Who cites it
11 citing papers in PubMed, 23 citations in OpenAlex.
- Safety, tolerability, and concordance with interferon-γ release assays of a recombinant ESAT6-MPT64 skin test: a phase 1 randomized clinical trial.Frontiers in immunology · 2026Trial
- Safety of a Novel ESAT6-CFP10 skin test compared with tuberculin skin test in a double-blind, randomized, controlled study.BMC infectious diseases · 2022Trial
- Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- The Impact of Body Mass Index on Latent Tuberculosis Infection: Combined Assessment in People Living with HIV.Pathogens (Basel, Switzerland) · 2025Article
- Advances in the Diagnosis of Latent Tuberculosis Infection.Infection and drug resistance · 2025Review
- Cracking the antigenic code of mycobacteria: CFP-10/ESAT-6 tuberculosis skin test and misleading results.Journal of clinical tuberculosis and other mycobacterial diseases · 2024Article
- A Comparative Study on the Mechanism of Delayed-Type Hypersensitivity Mediated by the RecombinantInternational journal of molecular sciences · 2023Article
- A Systematic Review on the Safety ofOpen forum infectious diseases · 2023Article
- Differential Diagnosis of Latent Tuberculosis Infection and Active Tuberculosis: A Key to a Successful Tuberculosis Control Strategy.Frontiers in microbiology · 2021Review
- Induration or erythema diameter not less than 5 mm as results of recombinant fusion protein ESAT6-CFP10 skin test for detecting M. tuberculosis infection.BMC infectious diseases · 2020Article
- Skin test of tuberculin purified protein derivatives with a dissolving microneedle-array patch.Drug delivery and translational research · 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
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This trial was conducted to explore the safety of recombinant fusion protein ESAT6-CFP10 as a skin test reagent for the diagnosis of Mycobacterium tuberculosis infection. Twenty-four healthy adult volunteers were recruited and randomized into four groups (groups A to D) to study four increasing doses of ESAT6-CFP10. All subjects in each dose group received an intradermal injection of reagent (0.1 ml) via the Mantoux technique. Then, the vital signs of all subjects were monitored, and skin reactions around injection sites and adverse events were recorded at different detection time points after the skin test. No serious adverse events were observed in this study. A total of 3 subjects had unexpected events. One subject in group A developed subcutaneous hemorrhage 24 h after the skin test, one subject in group B was found with red spots 15 min after the skin test, and another subject in group A showed abnormity during a chest X-ray after the skin test without affecting her health. One of three adverse events (red spots) was probably related to the recombinant ESAT6-CFP10 reagent. A single dose of 1, 5, 10, or 20 μg/ml of recombinant ESAT6-CFP10 as a skin test reagent for M. tuberculosis infection diagnosis is well tolerated and safe in China. (This study has been registered at ClinicalTrials.gov under registration no. NCT01999231.).
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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.