A study of MVA85A in healthy infants

Phase 2

Completed

• Conditions: Tuberculosis; Infections and Infestations; Respiratory tuberculosis, not confirmed bacteriologically or histologically

• Registration Number: ISRCTN39705371
• Lead Sponsor: Aeras Global TB Vaccine Foundation (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-05
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2784

Inclusion Criteria

1. Age of 126 through 154 days on the day of randomisation (Study Day 0), either sex
2. Written informed consent obtained from the parents/guardian
3. Weight: by chart greater than 3rd percentile on Study Day 0
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 28 day prior to Study Day 0
7. Ability to complete follow-up period of up to 728 days as required by the protocol
8. Completed simultaneous enrolment in the Aeras Vaccine Development Registry protocol

Exclusion Criteria

1. Acute illness on Study Day 0
2. Fever greater than or equal to 37.5°C on Study Day 0
3. Evidence of significant active infection on Study Day 0
4. Received a EPI immunisation within 28 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 tuberculosis or on anti-tuberculosis treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety profile of MVA85A/AERAS-485 in BCG-vaccinated, HIV-negative infants. Adverse events are recorded 28 days post-vaccination and serious adverse events are recorded for the entire study period.

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the efficacy of the MVA85A/AERAS-485 vaccine compared to controls in prevention of tuberculosis, assessed at 18 to 24 months post-vaccination<br>2. To evaluate the immunogenicity of the MVA85A/AERAS-485 vaccine compared to controls as described by ex-vivo Elispot, flow cytometric intracellular cytokine staining or whole blood intracellular cytokine assay<br>3. To discover correlates of protection from tuberculosis in infants vaccinated with MVA85A/AERAS-485, assessed at 18 to 24 months post-vaccination<br>4. To evaluate the QuantiFERON conversion rate at final study assessment in MVA85A/AERAS-485 recipients compared to controls in subjects without a diagnosis of tuberculosis during the trial, assessed at 18 to 24 months post-vaccination