Status:
COMPLETED
Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants
Lead Sponsor:
Aeras
Collaborating Sponsors:
Statens Serum Institut
Sanofi Pasteur, a Sanofi Company
Conditions:
Tuberculosis
Eligibility:
All Genders
64-196 years
Phase:
PHASE1
PHASE2
Brief Summary
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-Gu...
Detailed Description
This is a Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity and dose-range finding study in HIV-uninfected, HIV-unexposed, BCG-primed infants. The study vaccine AERAS-40...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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)
- Source documentation of birth weight ≥ 2.5 kg.
- Documented BCG vaccination within 72 hours of birth.
- Documented receipt of all age-appropriate EPI vaccines, except Rotavirus, for Cohorts 4 to 6 (see Appendix II).
- Source documentation of a negative HIV status in the mother, from any time during pregnancy with this child through randomization.
- Documentation of infant HIV negative exposure or infection status with negative HIV ELISA and HIV DNA PCR tests.
- Parent or legal guardian able and willing to provide signed informed consent.
- Participant/parent/legal guardian able to attend all scheduled visits and to comply with all trial procedures.
- EXCLUSION CRITERIA
- History of TB exposure in household or non-household contact.
- History/Evidence of TB disease or infection.
- Quantiferon positive.
- Prior TST test.
- Any one of Anemia, Neutropenia, Thrombocytopenia, SGPT (ALT), SGOT (AST) or Creatinine ≥ Grade 2
- Receipt of a live vaccine within 28 days prior to randomization.
- Receipt or planned receipt of any investigational vaccine.
- Known or suspected congenital immunodeficiency.
- Receipt of immunosuppressive therapy or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- Known or suspected autoimmune disease
- 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.
- Participation in another clinical trial for an investigational product (IP).
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding randomization, contraindicating IM vaccination.
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
- 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.
- Systemic antibiotic use within 48 hours prior to randomization.
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2017
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT01861730
Start Date
July 1 2013
End Date
December 22 2017
Last Update
April 9 2018
Active Locations (4)
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1
PHRU, Chris Hani Baragwanath Hospital
Johannesburg, Guateng, South Africa, 2091
2
Shandukani Research
Johannesburg, Hillbrow, South Africa, 2001
3
KID-CRU, Tygerberg Hospital
Cape Town, Tygerberg, South Africa, 7505
4
South African TB Vaccine Initiative (SATVI)
Worcester, South Africa