Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00953927
Protocol/serial number
C-020-485/TB020; 084785
Study information
Scientific title
Phase II double-blinded randomised controlled evaluation of MVA85A/AERAS-485 for safety, immunogenicity and prevention of tuberculosis in Bacillus Calmette-Guerin (BCG)-vaccinated, human immunodeficiency virus (HIV)-negative infants
Acronym
Study hypothesis
This is a phase II double-blinded randomised controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in (Bacillus Calmette-Guerin) BCG vaccinated infants without tuberculosis or human immunodeficiency virus (HIV) infection.
Ethics approval
1. University of Cape Town Research Ethics Committee, 17/12/2008, ref: 291/2008
2. Oxford Tropical Research Ethics Committee, 23/07/2008, ref: 37-08
3. Chesapeake Institutional Review Board, 09/07/2008, ref: 598
Study design
Phase II double-blinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Tuberculosis
Intervention
MVA85A/AERAS-485 is a modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Half of the subjects will receive a single intradermal vaccination of 1 x 10^8 pfu (plaque forming units) of MVA85A, the other half will receive a Candida skin test antigen (Candin) as a control. Follow up is for 18 - 24 months.
Intervention type
Drug
Phase
Phase II/III
Drug names
MVA85A/AERAS-485
Primary outcome measure
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
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
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
3. To discover correlates of protection from tuberculosis in infants vaccinated with MVA85A/AERAS-485, assessed at 18 to 24 months post-vaccination
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
Overall trial start date
13/07/2009
Overall trial end date
12/07/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
2784
Participant 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
Recruitment start date
13/07/2009
Recruitment end date
12/07/2012
Locations
Countries of recruitment
South Africa
Trial participating centre
University of Cape Town
Cape Town
7925
South Africa
Sponsor information
Organisation
Aeras Global TB Vaccine Foundation (USA)
Sponsor details
1405 Research Blvd.
Rockville
20850
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust - Strategic Award (ref: 084785)
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Funder name
Aeras Global Tuberculosis Vaccine Foundation
Alternative name(s)
Aeras Global TB Vaccine Foundation, Aeras
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
See https://clinicaltrials.gov/ct2/show/results/NCT00953927