Phase 1 Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Adolescent

This is an interventional prevention trial for Tuberculosis focused on measuring Tuberculosis, TB, vaccine, adjuvant Read More

Inclusion Criteria:

1. Male or female who is ≥14 and <19 years of age.
2. History of BCG vaccination that is confirmed through medical examination (i.e., asking a subject about his/her condition) or presence of a scar.
3. Adolescent who are QuantiFERON®-TB Gold Plus negative at screening.
4. Body mass index(BMI) ≥19 and ≤33 (kg/m2) who's Body weight≥40kg at screening.
5. Able to comply with the scheduled visits and are expected to continue working in the current medical institution and be available for a continuous follow-up by the investigator via provided contact information

6. Only for female subjects of childbearing potential:

   • Must be HCG-negative from serum or urine pregnancy test, at screening;

     • Agreed to use one of the following acceptable birth control methods to avoid pregnancy until the end of study (Visit 9): hormonal contraceptives, intrauterine device(IUD) or intrauterine system (IUS), tubal ligation or combination of barrier methods (combined use of barrier methods such as male condoms, female condoms, cervical cap, diaphragm, sponge or implant).
7. Subjects who understand the study procedures and voluntarily decide to participate in the study and sign the informed consent form.

Exclusion Criteria:

1. History of severe chronic disease that may compromise the safety of the subject during the study (e.g., impairment of pulmonary function from tuberculosis infection or other pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease or uncontrolled epilepsy).
2. Body temperature ≥ 38℃ at the time of randomization or within 24 hours before randomization, from acute fever, acute respiratory diseases, or active infection.
3. Malignant tumors or a history of malignant tumors.
4. Plans to have surgery during the study period.
5. Impaired immune functions including autoimmune disease or immunodeficiency disease.
6. History of Guillain-Barre syndrome.
7. Subjects with a history of anaphylaxis or severe allergic reaction to vaccines, eggs or other allergens.

8. Clinically significant abnormal laboratory values for any of the following tests conducted in the study center, prior to randomization:

   • Hemoglobin, hematocrit, absolute neutrophil count, absolute lymphocyte count or platelet count: < LLN (lower limit of normal)
   • White blood cell count: >ULN (upper limit of normal) or <LLN (lower limit of normal) (i.e., must be within normal limits)
   • ALT, AST, total bilirubin, alkaline phosphatase, creatinine or blood urea nitrogen(BUN): >ULN (upper limit of normal)
9. Received an immunosuppressant, immunity-modifying drug or other treatment that may affect the immune system including cytotoxic anti-cancer agents or radiotherapy, within 3 months before the randomization.
10. Use of systemic steroids (equivalent to daily prednisone ≥ 15mg/day for more than 14 days), inhaled or intranasal steroids, within 3 months before randomization; however, use of topical corticosteroids are acceptable, regardless of dose.
11. Use of immunoglobulin or blood products within 3 months before randomization or plans to use them during the study period.
12. Human Immunodeficiency Virus (HIV) positive at screening.
13. Subjects with chronic hepatitis (e.g., hepatitis B core antibody or hepatitis C antibody positive) at screening.
14. Unable to discontinue current chronic drug therapy such as thyroxin, insulin or other medications with hepatotoxicity or myelotoxicity; however, estrogen and progesterone replacement therapy or contraceptives and topical medications are acceptable.
15. Pregnant or lactating.
16. Use of other vaccines within 4 weeks before screening or plans to use other vaccines from screening to 4 weeks after last IP dosing, plan to use of other vaccines within 4 weeks before End visit.
17. Use of other investigational drugs within 4 weeks before screening.
18. Subjects with history of TB infectivity(Include active, latency TB infection) or positive for Tuberculin Skin Test.
19. Subjects living with a household member who has active TB or infectious TB.
20. Subjects deemed ineligible by investigator based on other reasons.