A study of MVA85A in healthy infants

ISRCTN	ISRCTN39705371
DOI	https://doi.org/10.1186/ISRCTN39705371
ClinicalTrials.gov (NCT)	NCT00953927
Protocol serial number	C-020-485/TB020; 084785
Sponsor	Aeras Global TB Vaccine Foundation (USA)
Funders	Wellcome Trust - Strategic Award (ref: 084785), Aeras Global Tuberculosis Vaccine Foundation

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

Wolfson Pavilion, Level 3
Faculty of Health Sciences
University of Cape Town
Anzio Road, Observatory
Cape Town
7925
South Africa

Study information

Primary study design	Interventional
Study design	Phase II double-blinded randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase II/III
Drug / device / biological / vaccine name(s)	MVA85A/AERAS-485
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	12/07/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	126 Days
Upper age limit	154 Days
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/03/2016: added link to results - basic reporting.