A study of MVA85A in healthy infants
| ISRCTN | ISRCTN39705371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39705371 |
| ClinicalTrials.gov number | NCT00953927 |
| Secondary identifying numbers | C-020-485/TB020; 084785 |
- Submission date
- 29/09/2009
- Registration date
- 05/10/2009
- Last edited
- 24/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Greg Hussey
Scientific
Scientific
Wolfson Pavilion, Level 3
Faculty of Health Sciences
University of Cape Town
Anzio Road, Observatory
Cape Town
7925
South Africa
Study information
| Study design | Phase II double-blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 13/07/2009 |
| Completion date | 12/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 126 Days |
| Upper age limit | 154 Days |
| Sex | Both |
| Target number of participants | 2784 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/07/2009 |
| Date of final enrolment | 12/07/2012 |
Locations
Countries of recruitment
- South Africa
Study participating centre
University of Cape Town
Cape Town
7925
South Africa
7925
South Africa
Sponsor information
Aeras Global TB Vaccine Foundation (USA)
Industry
Industry
1405 Research Blvd.
Rockville
20850
United States of America
| Website | http://www.aeras.org/home/home.php |
|---|---|
"ROR" |
https://ror.org/015facm29 |
Funders
Funder type
Charity
Wellcome Trust - Strategic Award (ref: 084785)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Aeras Global Tuberculosis Vaccine Foundation
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Aeras Global TB Vaccine Foundation
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | See | 12/12/2013 | No | No |
Editorial Notes
24/03/2016: added link to results - basic reporting.
