A Phase ⅠStudy of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried

NCT03026972 | Completed Phase 1

• 2 other identifiers: LTao-AEC/BC02-Ⅰ-healthyLTao
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

There are four populations in Recombinant Mycobacterium tuberculosis Vaccine Freeze-dried (AEC/BC02) phase I clinical research. The clinical study adopt open research design. Population I have 25 subjects who received Tuberculin purified protein derivative(TB-PPD) skin test and specific gamma-interferon (γ-IFN)detection whose results are both negative ;Population II have 30 subjects who received Tuberculin purified protein derivative(TB-PPD) and ESAT6-CFP10 skin test in different arms , specific gamma-interferon (γ-IFN) detection whose results are all negative.We call polulation III as uninfected TB PPD positve population.This group screened 30 subjects whose ESAT6-CFP10 skin test and specific gamma-interferon (γ-IFN)detection results are both negative,but Tuberculin purified protein derivative(TB-PPD) skin test positive.50 subjects whose three kinds of detection results are all positive γ-IFN,TB-PPD and ESAT6-CFP10 ) are named as population IV. After filtrating, injecting of population I start firstly.After ensure the safety of the population I,the population II～polulation IV carry out in turn the implementation at the same time.

Conditions

Tuberculosis

Keywords

Safety; Tolerance

Outcome Measures

Primary Outcomes (1)

• The number of participants with Adverse Events after coxal muscle injection

  The adverse events observed mainly from laboratory examination(including vital signs/routine blood/routingurine/Liver and kidney fuction/Electrocardiograghy and Chest X-ray detection),skin reactivity and local reaction after drug injection.Vital signs(breathing,pulse,blood pressure,body temperature) of each volunteer before each dose injection,and 30min after injection.Routine blood,routine urine,liver and kidney function,and ECG before first dose,third dose,sixth dose,and 7 days after the sixth time injection;skin reactivity and local reaction of rach volunteer at 30min before and after every injection.

  Up to a week after the sixth time injection

Secondary Outcomes (1)

• Laboratory markers of immunity

  Up to a week after the sixth time injection

Study Arms (4)

Population I

EXPERIMENTAL

Population I has 25 subjects,and it is considered as Tuberculin purified protein derivative(TB-PPD) skin test and specific gamma-interferon (γ-IFN) detection result all negative.Population I are coxal muscle injection of placebo or low dose adjuvant or low dose vaccine.

Biological: Placebo; Biological: Low dose adjuvant; Biological: Low dose vaccine

Population II

EXPERIMENTAL

Population II is considered as Tuberculin purified protein derivative(TB-PPD) skin test , ESAT6-CFP10 skin test and specific gamma-interferon (γ-IFN) detection result all negative.It has 30 subjects.Population II are coxal muscle injection of placebo or high dose adjuvant or high dose vaccine.

Biological: Placebo; Biological: High dose adjuvant; Biological: High dose vaccine

Population III

EXPERIMENTAL

Population III is considered as ESAT6-CFP10 skin test and specific gamma-interferon (γ-IFN) detection result negive,but Tuberculin purified protein derivative(TB-PPD) skin test positive.Population IV is needed 30 subjects.These subjects are coxal muscle injection of placebo or high dose adjuvant or high dose vaccine.This arm is uninfected TB PPD positve population.

Biological: Placebo; Biological: High dose adjuvant; Biological: High dose vaccine

Population IV

EXPERIMENTAL

Population IV is considered as Tuberculin purified protein derivative(TB-PPD) skin test and ESAT6-CFP10 skin test and specific gamma-interferon (γ-IFN) detection result all positive.We are called latent infection population,and need to screen 50 subjects through these three selection method.Population III are coxal muscle injection of placebo or adjuvant( including low dose adjuvant or high dose adjuvant) or vaccine(including low dose vaccine high dose vaccine).

Biological: Placebo; Biological: Low dose adjuvant; Biological: High dose adjuvant; Biological: Low dose vaccine; Biological: High dose vaccine

Interventions

Placebo BIOLOGICAL

The placebo drug contains 20mg mannitol and 10 millimole(mM) phosphate buffer(PB).population I～population IV are coxal muscle injection of placebo.

Population I; Population II; Population III; Population IV

Low dose adjuvant BIOLOGICAL

Population I and polulation IV are coxal muscle injection of low dose adjuvant.

Population I; Population IV

High dose adjuvant BIOLOGICAL

Population II ,Population III and Population IV are coxal muscle injection of high dose adjuvant.

Population II; Population III; Population IV

Low dose vaccine BIOLOGICAL

Population I and population IV are coxal muscle injection of low dose vaccine.

Population I; Population IV

High dose vaccine BIOLOGICAL

Population II,population III and population IV are coxal muscle injection of high dose vaccine .

Population II; Population III; Population IV

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Agreed to participate in the test and sign the informed consent;
• Subjects should comply with the requirements of the clinical trial protocol and be followed;
• Aged form 18-45 years old . Body mass index should be in the range of 18-30. Body Mass Index BMI: weight (Kg)/ \[height (m)\*height (m)\];
• Physical condition: body temperatue, blood pressure, heart rate and respiratory status are normal minor abnormalities but no abnormal symptoms and signs;
• Lab test including blood, urine, liver and kidney function are normal minor abnormalities but no abnormal symptoms and signs;
• ECG,X-ray chest radiograph are normal minor abnormalities but no abnormal symptoms and signs;
• Subjects have no history of tuberculosis;
• Subjects have no acute or chronic disease, acute infectious diseases, dermatoses or skin allergy caused by various reasons;
• Subject have not participated in other clinical drug trials or inoculated against other prophylactic and immune globulin in the nearly 3 months.

You may not qualify if:

• Suffering from other serious disease, e.g. tumor, autoimmune disease, progressive atherosclerosis, diabetes accompanied with complications, chronic obstructive pulmonary disease(COPD) needing oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc;
• Subjects were a history of TB;
• Subjects are immune dysfunction or abnormal, e.g. patients receive immunosuppressive agents or immunosuppressive agents, receive immunoglobulin preparations outsider the gastrointestinal or blood products within 3 months, extracted plasma or infected by immunodeficiency virus or related disease;
• Mentally or physically disabled,and have family history of convulsions, epilepsy, encephalopathy or mental illness.
• Subjects have took part in other clinical trials in the nearly 3 months,or vacinated any prophylactic;
• Allergic constitution, e.g. patients have allergic history to two or more kinds of drugs or food, or drug components;
• Substance abuse， drug or alcohol abuse;
• Pregnant or breast feeding female;
• people have birth plan during study or in six moons after entire immune;
• Any other cases that may influence the test evaluation.

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead
• Shanghai Public Health Clinical Center: collaborator
• Beijing Simoonrecord Pharmaceutical Information Consulting Co.,Ltd: collaborator

Study Sites (1)

Shanghai Public Health clinical Center

Shanghai, Shanghai Municipality, China

Location

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MeSH Terms

Conditions

Tuberculosis

Interventions

Adjuvants, Pharmaceutic; Vaccines

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Biological Products; Complex Mixtures

Study Officials

• Shuihua Lu

  Shanghai Public Health Clinical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 20, 2017
• Study Start: April 16, 2018
• Primary Completion: September 4, 2018
• Study Completion: October 30, 2019
• Last Updated: March 24, 2022

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)