NCT04239313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

May 27, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

January 16, 2020

Last Update Submit

September 2, 2022

Conditions

Tuberculosis

Keywords

TuberculosisVaccine

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 6 months after the sixth time injection

Secondary Outcomes (1)

  • Laboratory markers of immunity

    Up to 6 months after the sixth time injection

Study Arms (3)

Population I

EXPERIMENTAL

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.

Biological: Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)

Population II

ACTIVE COMPARATOR

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.

Biological: Low-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)

Population III

PLACEBO COMPARATOR

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.

Biological: Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo

Interventions

Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)BIOLOGICAL

Population I are coxal muscle injection of low dose vaccine.

Population I
Low-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)BIOLOGICAL

Population I are coxal muscle injection of low dose adjuvant.

Population II
Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placeboBIOLOGICAL

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

Population III

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (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.

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Infectious Disease Hospital

Wuhan, Hubei, 30040, China

Location

Related Publications (3)

  • Pulendran B, Ahmed R. Immunological mechanisms of vaccination. Nat Immunol. 2011 Jun;12(6):509-17. doi: 10.1038/ni.2039.

    PMID: 21739679BACKGROUND

  • 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.

    PMID: 15297503BACKGROUND

  • Li J, Fu L, Guo X, Yang Y, Dong J, Wang G, Zhao A. Novel BC02 Compound Adjuvant Enhances Adaptive and Innate Immunity Induced by Recombinant Glycoprotein E of Varicella-Zoster Virus. Vaccines (Basel). 2022 Dec 15;10(12):2155. doi: 10.3390/vaccines10122155.

    PMID: 36560565DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Zhaolin Huang

    Wuhan infectious disease hospital

    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 16, 2020

First Posted

January 27, 2020

Study Start

May 27, 2020

Primary Completion

February 24, 2021

Study Completion

June 20, 2022

Last Updated

September 6, 2022

Record last verified: 2022-09

Locations

CN(1)