A Study of MVA85A in Healthy Infants
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: MVA85A/AERAS-485; Candida Skin Test Antigen
Intervention description: Attenuated virus MVA vector with insertion. Single dose vaccine, 1 x 10^8 pfu.; 1 test, administered once as a placebo control.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2797.0
Sex: All
Minimum age: 126 Days
Maximum age: 182 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity
      and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without
      tuberculosis or HIV infection. This study planned to enroll 2784 infants (126 to 182 days of
      age) who received study vaccine or control and were followed for 15 - 36 months. The study
      was conducted at a single site in South Africa.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age of 126 through 182 days on the day of randomization (Study Day 0)

          2. Written informed consent obtained from the parents/guardian

          3. Weight: by chart >3rd percentile on Study Day 0 or, if < 3rd percentile, infant has
             shown a stable growth pattern

          4. BCG vaccination within 7 days of birth

          5. Generally good health confirmed by medical history and physical examination within 35
             days prior to Study Day 0

          6. Must have received age-appropriate doses of pneumococcal vaccine as recommended by the
             South African Department of Health but no injection within 14 day prior to Study Day 0

          7. Ability to complete follow-up period as required by the protocol

          8. Completed simultaneous enrollment in the Aeras Vaccine Development Registry protocol

        Exclusion Criteria:

          1. Acute illness on Study Day 0

          2. Fever >=37.5 degrees Celsius on Study Day 0

          3. Evidence of significant active infection on Study Day 0

          4. Received a Expanded Program of Immunization (EPI) within 14 days prior to Study Day 0

          5. Historical or virological evidence of individual or maternal human immunodeficiency
             virus (HIV-1) infection

          6. History of allergic disease or reactions likely to be exacerbated by any component of
             the study vaccine

          7. Previous medical history, or evidence, of an intercurrent illness that may compromise
             the safety of the infant in the study

          8. Evidence of chronic hepatitis from any cause

          9. History or evidence of any systemic disease on physical examination or any acute,
             chronic or intercurrent illness that, in the opinion of the investigator, may
             interfere with the evaluation of the safety or immunogenicity of the vaccine

         10. History of or known tuberculosis or treatment for tuberculosis

         11. Shared residence since birth with an individual with active tuberculosis or on
             anti-tuberculosis treatment for less than 2 months