Tuberculosis
Conditions
Interventions
vaccine
vaccine + placebo
Sponsors
Statens Serum Institut
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Healthy based on medical examination/history at the inclusion 3. Age 12-18 years (inclusive) 4. Signed informed consent 5. Signed informed assent 6. Prepared to grant authorized persons access to the medical records 7. If of childbearing potential, she must have abstained from sex or used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for the duration of the trial. 8. The volunteer is likely to comply with instructions
Exclusion criteria
Exclusion criteria: 1. Confirmed current or prior active TB disease based on clinical evaluation (history, physical findings and investigations) 2. Vaccinated with any vaccine 3 months before first vaccination 3. Administration of immune modulating drugs (oral steroids, immunosuppressive drugs or immunoglobulins) (inhaled and topical steroids excluded) 4. HIV sero-positive or unwilling to be tested for HIV 5. Participation in other clinical trials involving an experimental investigational product. 6. Known hypersensitivity to any of the vaccine components 7. Laboratory parameters outside of normal range considered clinically relevant in the opinion of the investigator. 8. Female participants who will most likely fail to abstain or to use adequate contraceptive precautions for 30 days prior to vaccination, and those who will most likely fail to agree to continue adequate contraceptive precautions for the duration of the trial 9. Positive pregnancy test 10. Breast feeding females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and IFN | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary/exploratory immunology | — |
Countries
South Africa
Contacts
Public ContactSoren Hoff
Statens Erum Instiut
Outcome results
None listed