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Completed

NCT Number: NCT05746611

Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein

Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients. Cohort I was injected with EC and TB-PPD in both arms, and cohort II was injected with EC only

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Key information

Conditions

Latent Tuberculosis Infection Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Mycobacterium Infections Tuberculosis

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Liuzhou, Guangxi, 545000, China

About this study

Assessment of effectiveness:

In cohort 1, the injection site reaction was examined at 0min, 24h, 48h and 72h after skin test, and the transverse and longitudinal diameters of the erythema and induration were measured and recorded in millimeters (mm), the larger the erythema or induration. Any blisters, necrosis, lymphangitis should be faithfully recorded.

In cohort 2, the injection site reaction was examined at 0min and 48-72 h after skin test, and the transverse and longitudinal diameters of the erythema and induration were measured and recorded in millimeters (mm), the larger the erythema or induration. Any blisters, necrosis, lymphangitis should be faithfully recorded.

Safety assessments:

The safety assessment included all expected and unexpected medical events that occurred during the observation period of the clinical trial (within 72 hours after the skin test) and were related or unrelated to the injection of the investigational drug. These included specific reactions such as redness, induration, blister, necrosis, and lymphangitis at the injection site (palmar forearm). Common and occasional adverse reactions include:

Local adverse reactions: injection site pruritus, injection site pain, injection site rash;

Systemic adverse reactions included fever, headache, nausea, fatigue, myalgia, diarrhea, vomiting, paresthesia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People aged 6 months and above (≥6 months).
  • Normal armpit body temperature (body temperature below 37.5℃ from 6 months to 14 years old, body temperature below 37.3℃ from 15 years old and above).
  • I or my guardian agree to participate in this study and sign the informed consent, willing and able to comply with the requirements of this clinical study protocol.

Exclusion criteria

  • Patients with acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute eye conjunctivitis, acute otitis media, extensive skin diseases and allergic diseases
  • A pure protein derivative or similar product was used within 3 months prior to the initiation of this trial.
  • Participated in other new drug clinical trials within 3 months prior to clinical trials.
  • Any circumstances were considered by the investigators to have the potential to influence the assessment of the trial.

Treatment and study plan

Recombinant Mycobacterium tuberculosis fusion protein for injection

Biological

For the suction test, EC0.1ml was injected into the palmar skin of the forearm by the Mondu's method

TB-PPD was injected

Biological

For the aspiration test, 0.1ml TB-PPD was injected into the palmar skin of the forearm by the Mondu's method

Primary outcomes

  1. In Cohort 1, the diameter of redness or induration at the reaction site

    Time frame: The skin test was performed at 0 minute after injection.

    In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 0 minute after skin testing.

  2. In Cohort 1, the diameter of redness or induration at the reaction site

    Time frame: The skin test was performed at 24 hours after injection.

    In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 24 hours after skin testing.

  3. In Cohort 1, the diameter of redness or induration at the reaction site

    Time frame: The skin test was performed at 48 hours after injection.

    In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 48 hours after skin testing.

  4. In Cohort 1, the diameter of redness or induration at the reaction site

    Time frame: The skin test was performed at 72 hours after injection.

    In cohort 1, the diameter of redness or induration at the reaction site was measured using a scale at 72 hours after skin testing.

  5. In Cohort 2, the diameter of redness or induration at the reaction site

    Time frame: 0 minute after the skin test

    In cohort 2, the diameter of skin redness or induration at the injection site was measured with a scale at 0 minute after the skin test.

  6. In Cohort 2, the diameter of redness or induration at the reaction site

    Time frame: Within 48 to 72 hours after skin testing

    In cohort 2, the diameter of skin redness or induration at the primary injection site was measured with a scale between 48 and 72 hours after skin testing.

  7. Number of cases in which all adverse events occurred.

    Time frame: The skin test was performed 72 hours after injection.

    Number of cases in which all adverse events occurred within 72 hours after skin testing.

  8. Incidence of SAE

    Time frame: Incidence of SAE within 72 hours after full vaccination

    Incidence of SAE within 72 hours after injection

Sponsors and collaborators

Lead sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Industry

Registry information

Official study title

To Conduct a Phase IV Clinical Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein in Community Population Aged 6 Months and Above.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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