Status:
COMPLETED
A Study of MVA85A in Healthy Children and Infants
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
University of Cape Town
Conditions:
Tuberculosis
Eligibility:
All Genders
6-11 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and highly immunogeni...
Detailed Description
M.tb is an intracellular organism and protective immunity is dependent on an intact cellular immune system. Both Class II-restricted CD4+ and Class I-restricted CD8+ T lymphocytes are important for pr...
Eligibility Criteria
Inclusion
- Eligible subjects will be children or infants aged 6 months - 11 years.
- Subject's parent/guardian is willing and able to give written informed consent for participation in the study.
- Subject is BCG vaccinated within the first 4 weeks of life
- In addition, informed assent will be obtained from all children aged 7 years or older unless they are adjudged incapable of understanding the basic concepts covered in the informed assent form, and an attempt will be made to obtain informed assent from children aged younger than 7 years if they are judged capable of understanding the basic concepts covered in the informed assent form
- Subject is in good health
- Subject has clinically acceptable laboratory results from screening visit
- CXR normal with no evidence of active or past TB
- Subject's parent/legal guardian is willing to allow child to undergo an HIV test
- Parent/guardian and subject able (in the Investigators opinion) and willing to comply with all study requirements.
Exclusion
- Subject is Mantoux (\>10 mm) and/or ELISPOT (\> 50 spots/million PBMC) positive for M tb (PPD, ESAT 6 and/or CFP10)
- Subject is HIV antibody positive
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient/subject at risk because of participation in the study, or may influence the result of the study, or the patient/subject's ability to participate in the study.
- Patient/subjects/healthy volunteers who have participated in another research study involving an investigational product in the past 12 weeks
- Patient/subjects previously enrolled into this study.
- Received a live vaccine (e.g. measles) in the previous 4 weeks or due to receive a live vaccine in the 4 weeks following enrolment
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00679159
Start Date
February 1 2008
End Date
December 1 2009
Last Update
February 9 2010
Active Locations (1)
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1
University Cape Town
Worcester, Western Cape, South Africa