Condition category
Infections and Infestations
Date applied
29/09/2009
Date assigned
05/10/2009
Last edited
24/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Greg Hussey

ORCID ID

Contact details

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

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 measures

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

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

http://www.aeras.org/home/home.php

Funders

Funder type

Charity

Funder name

Wellcome Trust - Strategic Award (ref: 084785)

Alternative name(s)

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

Results - basic reporting

Publication summary

See https://clinicaltrials.gov/ct2/show/results/NCT00953927

Publication citations

Additional files

Editorial Notes

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