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A Phase ⅠStudy of the Human Body Tolerance Research of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (NCT03026972)

Fourth Military Medical University
Beijing Simoonrecord Pharmaceutical Information Consulting Co.,Ltd
There are three populations in Recombinant Mycobacterium tuberculosis Vaccine Freeze-dried (AEC/BC02) phase I clinical research. The clinical study adopt randomized and 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 75 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.75 subjects whose three kinds of detection results are all positive(specific gamma interferon detection (γ-IFN),TB-PPD and ESAT6-CFP10 ) are named as population III. Three populations are screened at the same time. After filtrating, injecting of population I start firstly.After ensure the safety of the population I population II and population III carry out the implementation at the same time.
  • Biological: Placebo
    The placebo drug contains 20μg mannitol and 10 millimole(mM) phosphate buffer(PB).Population I、Population II and Population III are coxal muscle injection of placebo.
    • Biological: Low dose adjuvant
      Population I、Population II and Population III are coxal muscle injection of low dose adjuvant.
      • Biological: Middle dose adjuvant
        Population II and Population III are coxal muscle injection of middle dose adjuvant.
        • Biological: High dose adjuvant
          Population II and Population III are coxal muscle injection of high dose adjuvant.
          • Biological: Low dose vaccine
            Population I、Population II and Population III are coxal muscle injection of low dose vaccine.
            • Biological: Middle dose vaccine
              Population II and Population III are coxal muscle injection of middle dose vaccine.
              • Biological: High dose vaccine
                Population II and Population III are coxal muscle injection of high dose vaccine .
                Ages eligible for Study
                18 Years to 45 Years
                Genders eligible for Study
                All
                Accepts Healthy Volunteers
                Accepts Healthy Volunteers
                Inclusion Criteria:
                • Aged form 18-40 years old . Body mass index should be in the range of 18-26. Body Mass Index BMI: weight (Kg)/ height (M2);
                • Physical condition: ECG, blood pressure, heart rate, respiratory status and lab test indexed including blood, urine, liver and kidney function are normal minor abnormalities but no abnormal symptoms and signs;
                • People are normal after examination by X-ray chest radiograph;
                • 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;
                • 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;
                • Temperature is normal. (Temperature is less than or equal to 37℃ in quiet state )
                Exclusion Criteria:
                • Suffering from other serious disease, e.g. during cancer treatment, 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 have important primary disease;
                • 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;
                • Subjects have took part in other clinical trials in the nearly 3 months;
                • Allergic constitution, e.g. patients have allergic history to two or more kinds of drugs or food, or drug components.
                • Substance abuse and alcoholics;
                • Pregnant or breast feeding female;
                • Temperature is more than 37℃;
                • Mental or physical disability;
                • Any other cases that may influence the test evaluation.
                Firstly,all participants of the placebo group complete the first needle intramuscular injection. Secondly ,low-dose adjuvant group are injected after being sure of the security of placebo group in two hours. Thirdly, according to the safe results of low-dose adjuvant group in 3 days, the low-dose vaccine group are injected. The population II/ III are randomly divided into placebo group, low-dose adjuvant group, middle- dose adjuvant group, high-dose adjuvant group, low-dose vaccine group, middle-dose vaccine group and high-dose vaccine group, each group has 10 participants, except placebo groups have 15 cases. Each participant immune one type of placebo, adjuvant or vaccination every two weeks, totally six stitches . In the research, each subject receives only one dose of drug and cannot be subjected to experiments about dose escalation.

                All subjects of the population I are randomly divided into placebo (5 cases),low-dose adjuvant (10 cases) and low-dose vaccine (10 cases).

                The population Ⅰ subjects are received 6 needle times of placebo or adjuvant or vaccine by haunch deep intramuscular injection to provide security basis for population Ⅱ and population Ⅲ. The subjects should accept some physical examination during the clinical research. Vital signs (breathing, heart rate, blood pressure, body temperature) of each volunteer before each needle injection and 30min, 3day, 14day after injection; and local reaction of each volunteer at 30min, 3day, 14day after injection; all subjects should accept alcohol detection before each needle injection; routine blood, routine urine, liver and kidney function, and ECG before each injection and 3 days after the first needle injection and 14days after the sixth needle injection; chest X-ray detection before the first injection and 30 days after the sixth needle injection. All subjects should assess the changes of immunological indexes before the first injection, 3 days after the first injection, the fourth time before injection and 30 days after the sixth needle injection. The specific injection orders are as follows:

                - All the subjects of placebo group(5 cases) and low-dose adjuvant group(10 cases) will be injected on the same day, the adjuvant group subjects should be injected after all the placebo group completed and observed two hours safety;

                - All the subjects of low-dose vaccine (10 cases) will be injected on the third day if the placebo group and adjuvant group subjects are observed safety.

                - The clinical study of population Ⅱ and population Ⅲ will be carried out 3 days later if the low-dose vaccine group subjects of the population Ⅰ are observed safety; Each subject inoculates a dose of drug every two weeks, a total of six agents. In conclusion, the result of the Phase I Clinical Study of population I evaluate safety of different dose of Recombinant Mycobacterium tuberculosis Vaccine Freeze-dried(AEC/BCO2) in different population, but also provide a safe basis for the Phase I Clinical Study of population Ⅱ and population Ⅲ.

                The populationⅠsubjects are injected the first needle injection and observe safety after 3 days and then conducted clinical research population Ⅱ and Ⅲ in Phase I Clinical. The study population Ⅱ/Ⅲ will be injected to a placebo or adjuvant or vaccination and collect any adverse events and serious adverse events to evaluate its safety during the period of clinical research.

                The 75 subjects of study population Ⅱand 75 subjects of population III who meet the inclusion criteria and do not accord with standard of exclusion are randomly divided into placebo group, low-dose adjuvant group, middle-dose adjuvant group, high-dose adjuvant group, low-dose vaccine group, middle-dose vaccine group and high-dose vaccine group, each group has 10 participants, except placebo group have 15 cases.The subjects should accept some physical examination during the clinical research,and all the items of physical examination are as same as population I. Specific injection orders are as follows:

                - All the subjects of populationⅡof low-dose placebo group and adjuvant group will be injected on the sixth day, the adjuvant group subjects should be injected after all the placebo group received completed placebo and observed two hours safety;

                - The subjects of populationⅡof middle dose placebo group and adjuvant group and low doses of vaccine group will be injected after 3 days safety on the ninth day, at the same time, the low dose placebo group and adjuvant group of populationⅢwill be injected too.

                - The subjects of populationⅡof high dose placebo group and adjuvant group and middle doses of vaccine group will be injected after 4 days safety on the thirteen day, at the same time, the middle dose placebo group and adjuvant group and low doses of vaccine group of populationⅢwill be injected too.

                - The subjects of populationⅡof high dose vaccine group will be injected after 3 days safety on the16 day, at the same time, the high dose placebo group and adjuvant group and middle dose of vaccine group of populationⅢwill be injected too.

                ⑤ The subjects of populationⅢ of high dose vaccine group will be injected after 4 days safety on the 20 day.

                All subjects are vaccinated once every two weeks, a total of six times vaccination.

                2 locations

                China (2)
                • Shanghai Public Health clinical Center
                  not yet recruiting
                  Shanghai, Shanghai, China
                • Shanghai Public Health clinical Center
                  Not specified
                  Shanghai, Shanghai, China
                Status:
                not yet recruiting
                Type:
                Interventional
                Phase:
                Start:
                14 March, 2017
                Updated:
                19 January, 2017
                Participants:
                175
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