NCT00953927

A Study of MVA85A in Healthy Infants

Phase II Double-blinded Randomized Controlled Evaluation of MVA85A/AERAS-485 for Safety, Immunogenicity and Prevention of Tuberculosis in BCG-vaccinated, HIV-negative Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,797 (actual)
• Sponsor: Aeras · Academic / Other
• Sex: All
• Age: 126 Days – 182 Days
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	MVA85A/AERAS-485	Attenuated virus MVA vector with insertion. Single dose vaccine, 1 x 10\^8 pfu.
BIOLOGICAL	Candida Skin Test Antigen	1 test, administered once as a placebo control.

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-10-01
• First posted: 2009-08-06
• Last updated: 2016-05-24
• Results posted: 2013-12-12

Locations

3 sites across 1 country: South Africa