A Study of MVA85A in Healthy Infants

Aeras

Status and phase

Completed

Phase 2

Conditions

Tuberculosis

Treatments

Biological: MVA85A/AERAS-485

Biological: Candida Skin Test Antigen

Study type

Interventional

Funder types

Other

Identifiers

NCT00953927

Oxford TB020 (Other Identifier)

C-020-485

Details and patient eligibility

About

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.

Full description

This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in BCG vaccinated infants without tuberculosis or HIV infection. Infants (126 to 182 days) received intradermal (ID) study vaccine (MVA85A/AERAS-485 or Candida skin test antigen control). All infants were to be followed for at least 15 months after the last infant was enrolled into the study. Given completion of enrollment in 21 months, the total duration of follow-up for each infant was scheduled to be at least 15 months and up to 36 months. Infants were to be followed for the entire duration of the study both for the development of tuberculosis and serious adverse events.

On enrollment to the study, eligible infants were assigned to a study group starting with Study Group 1 and were randomized in a 1:1 ratio within a study group to receive either MVA85A/AERAS-485 or Candida skin test antigen control. Infants were assigned to a safety cohort (Study Group 1), then into 1 of 3 immunological assay evaluation groups (Study Groups 2-4), and finally the remainder of infants were assigned into the correlate of protection cohort (Study Group 5). At least 330 infants were to be randomized in Study Group 1, up to 50-60 infants each in Study Groups 2-4, and the remaining infants were randomized in Study Group 5.

Enrollment

2,797 patients

Sex

All

Ages

126 to 182 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age of 126 through 182 days on the day of randomization (Study Day 0)
Written informed consent obtained from the parents/guardian
Weight: by chart >3rd percentile on Study Day 0 or, if < 3rd percentile, infant has shown a stable growth pattern
BCG vaccination within 7 days of birth
Generally good health confirmed by medical history and physical examination within 35 days prior to Study Day 0
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
Ability to complete follow-up period as required by the protocol
Completed simultaneous enrollment in the Aeras Vaccine Development Registry protocol

Exclusion criteria

Acute illness on Study Day 0
Fever >=37.5 degrees Celsius on Study Day 0
Evidence of significant active infection on Study Day 0
Received a Expanded Program of Immunization (EPI) within 14 days prior to Study Day 0
Historical or virological evidence of individual or maternal human immunodeficiency virus (HIV-1) infection
History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine
Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the infant in the study
Evidence of chronic hepatitis from any cause
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
History of or known tuberculosis or treatment for tuberculosis
Shared residence since birth with an individual with active tuberculosis or on anti-tuberculosis treatment for less than 2 months