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Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants

CompletedPhase 1, Phase 2

Sponsor: Aeras

Conditions: Tuberculosis

Interventions: AERAS-404, Placebo

Countries: South Africa

Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity and dose-range finding study of AERAS-404 Tuberculosis (TB) vaccine administered intramuscularly in Bacille Calmette-Guerin (BCG) primed infants.

Eligibility overview

Sex: ALL

Age: 64 Days to 196 Days

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

INCLUSION CRITERIA

1. Age at time of entry:

Cohorts 1 to 6
* Cohorts 1 and 2: ≥ 168 to ≤ 196 days
* Cohorts 3A and 3B: ≥ 168 to ≤ 189 days
* Cohorts 4 and 5: ≥ 84 to ≤ 98 days (≥ 2 weeks after receipt of EPI vaccine doses at 10 weeks of age)
* Cohort 6 - coincident with EPI vaccine doses at 10 weeks of age (≥ 64 to ≤ 83 days of age)
2. Source documentation of birth weight ≥ 2.5 kg.
3. Documented BCG vaccination within 72 hours of birth.
4. Documented receipt of all age-appropriate EPI vaccines, except Rotavirus, for Cohorts 4 to 6 (see Appendix II).
5. Source documentation of a negative HIV status in the mother, from any time during pregnancy with this child through randomization.
6. Documentation of infant HIV negative exposure or infection status with negative HIV ELISA and HIV DNA PCR tests.
7. Parent or legal guardian able and willing to provide signed informed consent.
8. Participant/parent/legal guardian able to attend all scheduled visits and to comply with all trial procedures.

EXCLUSION CRITERIA

1. History of TB exposure in household or non-household contact.
2. History/Evidence of TB disease or infection.
3. Quantiferon positive.
4. Prior TST test.
5. Any one of Anemia, Neutropenia, Thrombocytopenia, SGPT (ALT), SGOT (AST) or Creatinine ≥ Grade 2
6. Receipt of a live vaccine within 28 days prior to randomization.
7. Receipt or planned receipt of any investigational vaccine.
8. Known or suspected congenital immunodeficiency.
9. Receipt of immunosuppressive therapy or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
10. Known or suspected autoimmune disease
11. Hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances as the vaccine used in the trial.
12. Participation in another clinical trial for an investigational product (IP).
13. Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding randomization, contraindicating IM vaccination.
14. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
15. Febrile illness (temperature ≥ 100.4°F \[≥ 38.0°C\]) within 24 hours prior to randomization.

Note: A subject may enroll after recovery from febrile illness if the subject is still within the age window.
16. Systemic antibiotic use within 48 hours prior to randomization.

Locations (4)

Johannesburg, Guateng, South Africa
Johannesburg, Hillbrow, South Africa
Cape Town, Tygerberg, South Africa
Worcester, South Africa