TuberculosisPhase 1AEC/BC02NCT03026972
A Phase ⅠStudy of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried
A Phase 1 study testing Low dose adjuvant, High dose adjuvant and Low dose vaccine in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Low dose adjuvant, High dose adjuvant and Low dose vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2018to 30 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Public Health clinical Center
Shanghai, Shanghai Municipality
About this study
Official title: A Phase ⅠStudy of the Human Body Tolerance Research of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried
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.
Read the detailed description
Consider the safety of the inoculation,the trial is conducted in the following order:
Population I start firstly, polulation II～population IV is sarted when population I is finished the entire immune and observation safety.Population II and population III should proceed simultaneously,and these two kinds of population finish injecting the first doses of placebo group after 4weeks,population IV start.
All participants of the placebo group and adjuvant group complete the first needle intramuscular injection.5 subjects of Low-dose vaccine group are injected after being sure of the security of placebo and adjucant groups after 3 days. When these low-dose vaccine subjects is sure of safety in 2h,the rest of 5 subjects are injected.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.
The population Ⅰ subjects are received 6 needle times of placebo or low-dose adjuvant or low-dose vaccine by haunch deep intramuscular injection to provide security basis. The subjects should accept some physical examination during the clinical research. Vital signs (breathing, pulse, blood pressure, body temperature) of each volunteer before each needle injection and 30min; and local reaction of each volunteer at 30min after injection;routine blood, routine urine, liver and kidney function, and ECG before first-dose, third-dose,forth-dose and sixth-dose,7 days after the sixth needle injection; Female HCG is tested before each needle injection and 7days after the sixth dose injected; chest X-ray detection before the first injection and 7 days after the sixth needle injection. All subjects should assess the changes of immunological indexes before the first injection, the fourth time before injection and 7 days after the sixth needle injection. The specific injection orders are as follows:
①All 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;
② 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.
③The 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.
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.When the above two kinds of population are injected first doses of placebo after 4 weeks,the low-dose group of population IV proceed.High-dose group of population IV conduct trial after the low-dose group injected first dose of placebo later 1 week.
The 30 subjects of study population Ⅱand 30 subjects of population III who meet the inclusion criteria and do not accord with standard of exclusion are divided into placebo group,high-dose adjuvant group and high-dose vaccine group, each group has 10 participants.The 50 subjects of population IV are invidided into low-dose group and high-dose group,each group of 25 subjects.The Low-dose group consiste of 5 placebo subjects,10 adjuvant subjects and 10 vaccine subjects.The high-dose grouping is same as low-dose group.Every subject must 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:
①Population II and population III should proceed simultaneously,and these two kinds of population finish injecting the first doses of placebo group after 4weeks,population IV start;
②High-dose group of population IV conduct trial after the low-dose group injected first dose of placebo later 1 week;
③Every pupolation are injected placebo and adjuvant firstly;5 subjects of Low-dose vaccine group are injected after being sure of the security of placebo and adjucant groups after 3 days. When these low-dose vaccine subjects is sure of safety in 2h,the rest of 5 subjects are injected.
All subjects are vaccinated once every two weeks, a total of six times vaccination.
- Conditions
- Tuberculosis
- Being tested
- Placebo, Low dose adjuvant, High dose adjuvant, Low dose vaccine, High dose vaccine
- Keywords
- Safety, Tolerance
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
The placebo drug contains 20mg mannitol and 10 millimole(mM) phosphate buffer(PB).population I～population IV are coxal muscle injection of placebo.
Low dose adjuvantBiological
Population I and polulation IV are coxal muscle injection of low dose adjuvant.
High dose adjuvantBiological
Population II ,Population III and Population IV are coxal muscle injection of high dose adjuvant.
Low dose vaccineBiological
Population I and population IV are coxal muscle injection of low dose vaccine.
High dose vaccineBiological
Population II,population III and population IV are coxal muscle injection of high dose vaccine .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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). Receives: Biological: Placebo; Biological: Low dose adjuvant; Biological: High dose adjuvant; Biological: Low dose vaccine; Biological: High dose vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to a week after the sixth time injection
Secondary outcomes (1)
Laboratory markers of immunity
Evaluation of IFN-γand antibody level of before and after the immune,intracellular cytokine staining in blood .
Measured: Up to a week after the sixth time injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start16 Apr 2018
- Primary completion4 Sep 2018
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Public Health Clinical Center, Beijing Simoonrecord Pharmaceutical Information Consulting Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- Shuihua Lu, Principal investigator, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026972
- Sponsor's protocol ID
- LTao-AEC/BC02-Ⅰ-healthy
- Other IDs
- LTao
- Acronym
- AEC/BC02
- Status last verified
- Dec 2019
- First submitted
- 12 Jan 2017
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Young D, Dye C. The development and impact of tuberculosis vaccines. Cell. 2006 Feb 24;124(4):683-7. doi: 10.1016/j.cell.2006.02.013.
PubMed 16497578Lalvani A, Nagvenkar P, Udwadia Z, Pathan AA, Wilkinson KA, Shastri JS, Ewer K, Hill AV, Mehta A, Rodrigues C. Enumeration of T cells specific for RD1-encoded antigens suggests a high prevalence of latent Mycobacterium tuberculosis infection in healthy urban Indians. J Infect Dis. 2001 Feb 1;183(3):469-77. doi: 10.1086/318081. Epub 2000 Dec 21.
PubMed 11133379Pathan AA, Wilkinson KA, Klenerman P, McShane H, Davidson RN, Pasvol G, Hill AV, Lalvani A. Direct ex vivo analysis of antigen-specific IFN-gamma-secreting CD4 T cells in Mycobacterium tuberculosis-infected individuals: associations with clinical disease state and effect of treatment. J Immunol. 2001 Nov 1;167(9):5217-25. doi: 10.4049/jimmunol.167.9.5217.
PubMed 11673535Targeted tuberculin testing and treatment of latent tuberculosis infection. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. This is a Joint Statement of the American Thoracic Society (ATS) and the Centers for Disease Control and Prevention (CDC). This statement was endorsed by the Council of the Infectious Diseases Society of America. (IDSA), September 1999, and the sections of this statement. Am J Respir Crit Care Med. 2000 Apr;161(4 Pt 2):S221-47. doi: 10.1164/ajrccm.161.supplement_3.ats600. No abstract available.
PubMed 10764341Taylor Z, Nolan CM, Blumberg HM; American Thoracic Society; Centers for Disease Control and Prevention; Infectious Diseases Society of America. Controlling tuberculosis in the United States. Recommendations from the American Thoracic Society, CDC, and the Infectious Diseases Society of America. MMWR Recomm Rep. 2005 Nov 4;54(RR-12):1-81.
PubMed 16267499Horsburgh CR Jr. Priorities for the treatment of latent tuberculosis infection in the United States. N Engl J Med. 2004 May 13;350(20):2060-7. doi: 10.1056/NEJMsa031667.
PubMed 15141044Tyagi AK, Nangpal P, Satchidanandam V. Development of vaccines against tuberculosis. Tuberculosis (Edinb). 2011 Sep;91(5):469-78. doi: 10.1016/j.tube.2011.01.003. Epub 2011 Feb 18.
PubMed 21334259Brandt L, Feino Cunha J, Weinreich Olsen A, Chilima B, Hirsch P, Appelberg R, Andersen P. Failure of the Mycobacterium bovis BCG vaccine: some species of environmental mycobacteria block multiplication of BCG and induction of protective immunity to tuberculosis. Infect Immun. 2002 Feb;70(2):672-8. doi: 10.1128/IAI.70.2.672-678.2002.
PubMed 11796598McShane H, Hill A. Prime-boost immunisation strategies for tuberculosis. Microbes Infect. 2005 May;7(5-6):962-7. doi: 10.1016/j.micinf.2005.03.009. Epub 2005 Apr 15.
PubMed 15890555Murray JF. [Current clinical manifestations of tuberculosis]. Rev Prat. 1996 Jun 1;46(11):1344-9. French.
PubMed 8794617Turner OC, Roberts AD, Frank AA, Phalen SW, McMurray DM, Content J, Denis O, D'Souza S, Tanghe A, Huygen K, Orme IM. Lack of protection in mice and necrotizing bronchointerstitial pneumonia with bronchiolitis in guinea pigs immunized with vaccines directed against the hsp60 molecule of Mycobacterium tuberculosis. Infect Immun. 2000 Jun;68(6):3674-9. doi: 10.1128/IAI.68.6.3674-3679.2000.
PubMed 10816527Taylor JL, Turner OC, Basaraba RJ, Belisle JT, Huygen K, Orme IM. Pulmonary necrosis resulting from DNA vaccination against tuberculosis. Infect Immun. 2003 Apr;71(4):2192-8. doi: 10.1128/IAI.71.4.2192-2198.2003.
PubMed 12654841Olsen AW, Williams A, Okkels LM, Hatch G, Andersen P. Protective effect of a tuberculosis subunit vaccine based on a fusion of antigen 85B and ESAT-6 in the aerosol guinea pig model. Infect Immun. 2004 Oct;72(10):6148-50. doi: 10.1128/IAI.72.10.6148-6150.2004.
PubMed 15385521Andersen P, Doherty TM. TB subunit vaccines--putting the pieces together. Microbes Infect. 2005 May;7(5-6):911-21. doi: 10.1016/j.micinf.2005.03.013. Epub 2005 Apr 14.
PubMed 15878836Torres M, Herrera T, Villareal H, Rich EA, Sada E. Cytokine profiles for peripheral blood lymphocytes from patients with active pulmonary tuberculosis and healthy household contacts in response to the 30-kilodalton antigen of Mycobacterium tuberculosis. Infect Immun. 1998 Jan;66(1):176-80. doi: 10.1128/IAI.66.1.176-180.1998.
PubMed 9423855
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase ⅠStudy of the Human Body Tolerance Research of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried
- ClinicalTrials.gov ID
- NCT03026972
- Acronym / sponsor ID
- AEC/BC02 / LTao-AEC/BC02-Ⅰ-healthy
- Conditions
- Tuberculosis
- Keywords
- Safety, Tolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Public Health Clinical Center, Beijing Simoonrecord Pharmaceutical Information Consulting Co.,Ltd
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Consider the safety of the inoculation,the trial is conducted in the following order:
Population I start firstly, polulation II～population IV is sarted when population I is finished the entire immune and observation safety.Population II and population III should proceed simultaneously,and these two kinds of population finish injecting the first doses of placebo group after 4weeks,population IV start.
All participants of the placebo group and adjuvant group complete the first needle intramuscular injection.5 subjects of Low-dose vaccine group are injected after being sure of the security of placebo and adjucant groups after 3 days. When these low-dose vaccine subjects is sure of safety in 2h,the rest of 5 subjects are injected.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.
The population Ⅰ subjects are received 6 needle times of placebo or low-dose adjuvant or low-dose vaccine by haunch deep intramuscular injection to provide security basis. The subjects should accept some physical examination during the clinical research. Vital signs (breathing, pulse, blood pressure, body temperature) of each volunteer before each needle injection and 30min; and local reaction of each volunteer at 30min after injection;routine blood, routine urine, liver and kidney function, and ECG before first-dose, third-dose,forth-dose and sixth-dose,7 days after the sixth needle injection; Female HCG is tested before each needle injection and 7days after the sixth dose injected; chest X-ray detection before the first injection and 7 days after the sixth needle injection. All subjects should assess the changes of immunological indexes before the first injection, the fourth time before injection and 7 days after the sixth needle injection. The specific injection orders are as follows:
①All 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;
② 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.
③The 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.
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.When the above two kinds of population are injected first doses of placebo after 4 weeks,the low-dose group of population IV proceed.High-dose group of population IV conduct trial after the low-dose group injected first dose of placebo later 1 week.
The 30 subjects of study population Ⅱand 30 subjects of population III who meet the inclusion criteria and do not accord with standard of exclusion are divided into placebo group,high-dose adjuvant group and high-dose vaccine group, each group has 10 participants.The 50 subjects of population IV are invidided into low-dose group and high-dose group,each group of 25 subjects.The Low-dose group consiste of 5 placebo subjects,10 adjuvant subjects and 10 vaccine subjects.The high-dose grouping is same as low-dose group.Every subject must 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:
①Population II and population III should proceed simultaneously,and these two kinds of population finish injecting the first doses of placebo group after 4weeks,population IV start;
②High-dose group of population IV conduct trial after the low-dose group injected first dose of placebo later 1 week;
③Every pupolation are injected placebo and adjuvant firstly;5 subjects of Low-dose vaccine group are injected after being sure of the security of placebo and adjucant groups after 3 days. When these low-dose vaccine subjects is sure of safety in 2h,the rest of 5 subjects are injected.
All subjects are vaccinated once every two weeks, a total of six times vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Population I | Experimental | Biological: Placebo, Biological: Low dose adjuvant, Biological: Low dose vaccinePopulation 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. |
| Population II | Experimental | Biological: Placebo, Biological: High dose adjuvant, Biological: High dose vaccinePopulation 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. |
| Population III | Experimental | Biological: Placebo, Biological: High dose adjuvant, Biological: High dose vaccinePopulation 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. |
| Population IV | Experimental | Biological: Placebo, Biological: Low dose adjuvant, Biological: High dose adjuvant, Biological: Low dose vaccine, Biological: High dose vaccinePopulation 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe placebo drug contains 20mg mannitol and 10 millimole(mM) phosphate buffer(PB).population I～population IV are coxal muscle injection of placebo. | Biological | Population I, Population II, Population III, Population IV |
| Low dose adjuvantPopulation I and polulation IV are coxal muscle injection of low dose adjuvant. | Biological | Population I, Population IV |
| High dose adjuvantPopulation II ,Population III and Population IV are coxal muscle injection of high dose adjuvant. | Biological | Population II, Population III, Population IV |
| Low dose vaccinePopulation I and population IV are coxal muscle injection of low dose vaccine. | Biological | Population I, Population IV |
| High dose vaccinePopulation II,population III and population IV are coxal muscle injection of high dose vaccine . | Biological | Population II, Population III, Population IV |
Primary outcome
The number of participants with Adverse Events after coxal muscle injection
Time frame: Up to a week after the sixth time 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.
1 secondary outcome
Laboratory markers of immunity
Time frame: Up to a week after the sixth time injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Background: PubMed 16497578Young D, Dye C. The development and impact of tuberculosis vaccines. Cell. 2006 Feb 24;124(4):683-7. doi: 10.1016/j.cell.2006.02.013.
- Background: PubMed 11133379Lalvani A, Nagvenkar P, Udwadia Z, Pathan AA, Wilkinson KA, Shastri JS, Ewer K, Hill AV, Mehta A, Rodrigues C. Enumeration of T cells specific for RD1-encoded antigens suggests a high prevalence of latent Mycobacterium tuberculosis infection in healthy urban Indians. J Infect Dis. 2001 Feb 1;183(3):469-77. doi: 10.1086/318081. Epub 2000 Dec 21.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuihua Lu principal investigator
Shanghai Public Health Clinical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose adjuvant, High dose adjuvant and Low dose vaccine in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with Adverse Events after coxal muscle injection (time frame: Up to a week after the sixth time injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03026972, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.