Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents

• Status: Completed
• Trial end date: 2017-10-06
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and BCG Revaccination in Healthy Adolescents

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aeras
• Collaborator: Sanofi Pasteur, a Sanofi Company
• Treatments: BCG Vaccine

Criteria

Inclusion Criteria:

1. Has completed the written informed consent and assent process

2. Is age ≥ 12 years and ≤ 17 years on Study Day 0

3. Agrees to stay in contact with the study site for the duration of the study, provide updated contact information

4. For female subjects: agrees to avoid pregnancy from 28 days prior to Study Day 0 and for the full duration of the study.

5. Has general good health, confirmed by medical history and physical examination

6. Had BCG vaccination at least 5 years ago documented through medical history or by presence of healed BCG scar

7. Tests QFT-GIT negative at screening, using the manufacturer's recommended threshold of 0.35 IU/mL

Exclusion Criteria:

1. Acute illness on Study Day 0

2. Oral temperature ≥37.5°C on Study Day 0

3. Clinically significant (and no more than Grade 1 on the Toxicity Scale) abnormal laboratory values from blood collected within 21 days

4. Evidence of clinically significant (and no more than Grade 1 on the Toxicity Scale) systemic or local disease on urinalysis

5. History or evidence of any clinically significant systemic disease, or any acute or chronic illness that might affect the safety, immunogenicity, or efficacy of study vaccine in the opinion of the investigator

6. History of treatment for active TB disease or latent Mtb infection

7. History or evidence, including chest X-ray, of active TB disease

8. Shared residence with an individual receiving anti-TB treatment, or known incompletely treated culture or smear positive TB

9. History of autoimmune disease or immunosuppression

10. Used immunosuppressive medication within 42 days before Study Day 0

11. Received immunoglobulin or blood products within 42 days before Study Day 0

12. Received any investigational drug therapy or investigational vaccine within 182 days before Study Day 0

13. Received investigational TB vaccine, other than BCG

14. Planned administration/administration of a licensed vaccine in the period starting 28 days before and ending 28 days after each dose of study vaccine

15. History or laboratory evidence of any past or present possible immunodeficiency state not limited to any lab indication of HIV-1 infection

16. History of allergic disease likely to be exacerbated by any component of the study vaccine

17. History of alcohol or drug abuse

18. All female subjects: currently pregnant or lactating/nursing; or positive urine pregnancy test during screening

19. Received a (TST) within 3 months (90 days) prior to Study Day 0.

20. Any current medical, psychiatric, occupational, substance abuse problems problems that in opinion of investigator will make unlikely for the subject to comply with the protocol