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A Phase Ib Study of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)

Primary Purpose

Tuberculosis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
Low-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo
Sponsored by
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tuberculosis focused on measuring Tuberculosis, Vaccine

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • (1) Age 18-45 years old, body mass index (BMI) = weight (kg) / [(height (m) × (height (m))], in the range of 18.0 to 29.9 (including the boundary value);
  • (2) I agree to participate in this study and sign an informed consent, and I am willing and able to comply with the requirements of the clinical research protocol;
  • (3) Vital signs (reference range of vital signs: systolic blood pressure 90 ~ 140mmHg (including boundary value), diastolic blood pressure 60 ~ 90mmHg (including boundary value), pulse rate 50 ~ 100 beats / min (including boundary value), body temperature (ear Temperature) 35.4 ~ 37.7 ℃ (including the boundary value)), physical examination, clinical laboratory (blood routine, urine routine, blood biochemistry, hepatitis B and AIDS syphilis examination, etc.), electrocardiogram and abdominal B-ultrasound examination, the results showed no abnormalities or abnormalities Non-clinical significance
  • (4) Chest X-ray examination showed no abnormalities;
  • (5) TB-PPD skin test induration average diameter <5mm and QFT negative test results;
  • (6) No contraindications to vaccination and no history of TB exposure.

Exclusion Criteria:

  • (1) (Ask) Suffering from acute disease, severe chronic disease, acute episode of chronic disease, acute infectious disease, such as: treatment of malignant tumor, autoimmune disease, progressive atherosclerosis or diabetes with complications, Chronic obstructive pulmonary disease, acute or progressive liver or kidney disease, congestive heart failure, etc. that require oxygen therapy;
  • (2) (Ask) those with eczema or other skin diseases;
  • (3) (Ask) Those who are known to be allergic to the components of the test drug;
  • (4) (Ask) those who have a clear diagnosis of tuberculosis, extrapulmonary tuberculosis or tuberculosis has been cured;
  • (5) (Ask) a history of convulsions, epilepsy, encephalopathy and neurological symptoms or signs;
  • (6) (Ask) long-term use of antibiotics;
  • (7) (Ask) People with known or suspected immune function impairment or abnormality, such as those who received immunosuppressant or immune enhancer treatment within 3 months, received gastrointestinal within 3 months Those who have immunoglobulin preparations or blood products or plasma extracts outside the tract, those with human immunodeficiency virus infection or related diseases;
  • (8) (inquiry) those who have no spleen, functional spleen, and spleen or splenectomy caused by any situation
  • (9) Examination of one or more clinical significance of hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti- Treponema pallidum specific antibody;
  • (10) Those who have a history of drug abuse or are positive for drug screening;
  • (11) Those who donated or lost blood more than 400mL within 3 months before screening;
  • (12) those with acute febrile diseases and infectious diseases;
  • (13) those who are pregnant, lactating, or have a positive pregnancy test before vaccination, or who cannot guarantee contraception during the study period of this clinical trial;
  • (14) Participated in other new drug clinical trials 3 months before screening;
  • (15) Any situation that the investigator believes may affect the eva

Sites / Locations

  • Wuhan Infectious Disease Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Population I

Population II

Population III

Arm Description

Population I has 10 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 low dose vaccine.

Population I has 10 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 low dose adjuvant.

Population I has 10 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.

Outcomes

Primary Outcome Measures

The number of adverse events after intramuscular 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,fourth dose,and 7 days after the sixth time injection;skin reactivity and local reaction of rach volunteer at 30min before and after every injection.

Secondary Outcome Measures

Laboratory markers of immunity
Evaluation of IFN-γand antibody level of before and after the immune,intracellular cytokine staining in blood .

Full Information

First Posted
January 16, 2020
Last Updated
September 2, 2022
Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04239313
Brief Title
A Phase Ib Study of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
Official Title
Phase Ib Clinical Trial Evaluating the Safety and Immunogenicity of Freeze-dried Recombinant Tuberculosis Vaccine (AEC / BC02) in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
June 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Single-center, single-dose, placebo-controlled, open-label trials were used to evaluate the safety and immunogenicity of low-dose adjuvants and low-dose vaccines in the upper arm deltoid muscle intramuscularly in the double negative population. Thirty (PPD-QFT-) healthy adult subjects aged 18-45 were selected and divided into placebo group, low-dose adjuvant group, and low-dose vaccine group. During the test, each subject must not change groups and inoculate drugs. Every two weeks (0-2-4-6-8-10 weeks), alternately inject a dose of placebo or left and right upper arm deltoid muscles. Low-dose adjuvant or low-dose vaccine, a total of 6 doses.
Detailed Description
Single-center, single-dose, placebo-controlled, open-label trials were used to evaluate the safety and immunogenicity of low-dose adjuvants and low-dose vaccines in the upper arm deltoid muscle intramuscularly in the double negative population. Thirty (PPD-QFT-) healthy adult subjects aged 18-45 were selected and divided into placebo group, low-dose adjuvant group, and low-dose vaccine group. During the test, each subject must not change groups and inoculate drugs. Every two weeks (0-2-4-6-8-10 weeks), alternately inject a dose of placebo or left and right upper arm deltoid muscles. Low-dose adjuvant or low-dose vaccine, a total of 6 doses. Collected adverse events within 14 days after each dose of vaccination, non-recruited adverse events within 30 days after the first dose of vaccination, subjects will receive 6 months follow-up after the last dose of vaccination, and study throughout Serious adverse events were recorded during the period. Immunogenicity will be assessed before the first dose, 24 hours after the third dose, before the fourth dose, 24 hours after the sixth dose, 1 month, and 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Tuberculosis, Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Population I
Arm Type
Experimental
Arm Description
Population I has 10 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 low dose vaccine.
Arm Title
Population II
Arm Type
Active Comparator
Arm Description
Population I has 10 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 low dose adjuvant.
Arm Title
Population III
Arm Type
Placebo Comparator
Arm Description
Population I has 10 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.
Intervention Type
Biological
Intervention Name(s)
Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
Intervention Description
Population I are coxal muscle injection of low dose vaccine.
Intervention Type
Biological
Intervention Name(s)
Low-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
Intervention Description
Population I are coxal muscle injection of low dose adjuvant.
Intervention Type
Biological
Intervention Name(s)
Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo
Intervention Description
The placebo drug contains 20mg mannitol and 10 millimole(mM) phosphate buffer(PB).population I are coxal muscle injection of placebo.
Primary Outcome Measure Information:
Title
The number of adverse events after intramuscular injection
Description
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,fourth dose,and 7 days after the sixth time injection;skin reactivity and local reaction of rach volunteer at 30min before and after every injection.
Time Frame
Up to 6 months after the sixth time injection
Secondary Outcome Measure Information:
Title
Laboratory markers of immunity
Description
Evaluation of IFN-γand antibody level of before and after the immune,intracellular cytokine staining in blood .
Time Frame
Up to 6 months after the sixth time injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (1) Age 18-45 years old, body mass index (BMI) = weight (kg) / [(height (m) × (height (m))], in the range of 18.0 to 29.9 (including the boundary value); (2) I agree to participate in this study and sign an informed consent, and I am willing and able to comply with the requirements of the clinical research protocol; (3) Vital signs (reference range of vital signs: systolic blood pressure 90 ~ 140mmHg (including boundary value), diastolic blood pressure 60 ~ 90mmHg (including boundary value), pulse rate 50 ~ 100 beats / min (including boundary value), body temperature (ear Temperature) 35.4 ~ 37.7 ℃ (including the boundary value)), physical examination, clinical laboratory (blood routine, urine routine, blood biochemistry, hepatitis B and AIDS syphilis examination, etc.), electrocardiogram and abdominal B-ultrasound examination, the results showed no abnormalities or abnormalities Non-clinical significance (4) Chest X-ray examination showed no abnormalities; (5) TB-PPD skin test induration average diameter <5mm and QFT negative test results; (6) No contraindications to vaccination and no history of TB exposure. Exclusion Criteria: (1) (Ask) Suffering from acute disease, severe chronic disease, acute episode of chronic disease, acute infectious disease, such as: treatment of malignant tumor, autoimmune disease, progressive atherosclerosis or diabetes with complications, Chronic obstructive pulmonary disease, acute or progressive liver or kidney disease, congestive heart failure, etc. that require oxygen therapy; (2) (Ask) those with eczema or other skin diseases; (3) (Ask) Those who are known to be allergic to the components of the test drug; (4) (Ask) those who have a clear diagnosis of tuberculosis, extrapulmonary tuberculosis or tuberculosis has been cured; (5) (Ask) a history of convulsions, epilepsy, encephalopathy and neurological symptoms or signs; (6) (Ask) long-term use of antibiotics; (7) (Ask) People with known or suspected immune function impairment or abnormality, such as those who received immunosuppressant or immune enhancer treatment within 3 months, received gastrointestinal within 3 months Those who have immunoglobulin preparations or blood products or plasma extracts outside the tract, those with human immunodeficiency virus infection or related diseases; (8) (inquiry) those who have no spleen, functional spleen, and spleen or splenectomy caused by any situation (9) Examination of one or more clinical significance of hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti- Treponema pallidum specific antibody; (10) Those who have a history of drug abuse or are positive for drug screening; (11) Those who donated or lost blood more than 400mL within 3 months before screening; (12) those with acute febrile diseases and infectious diseases; (13) those who are pregnant, lactating, or have a positive pregnancy test before vaccination, or who cannot guarantee contraception during the study period of this clinical trial; (14) Participated in other new drug clinical trials 3 months before screening; (15) Any situation that the investigator believes may affect the eva
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaolin Huang
Organizational Affiliation
Wuhan infectious disease hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wuhan Infectious Disease Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
30040
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
21739679
Citation
Pulendran B, Ahmed R. Immunological mechanisms of vaccination. Nat Immunol. 2011 Jun;12(6):509-17. doi: 10.1038/ni.2039.
Results Reference
background
PubMed Identifier
15297503
Citation
Mostowy S, Onipede A, Gagneux S, Niemann S, Kremer K, Desmond EP, Kato-Maeda M, Behr M. Genomic analysis distinguishes Mycobacterium africanum. J Clin Microbiol. 2004 Aug;42(8):3594-9. doi: 10.1128/JCM.42.8.3594-3599.2004.
Results Reference
background

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A Phase Ib Study of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)

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