Tuberculosis Clinical Trial
Official title:
A Phase II Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Children and Infants After BCG Vaccination at Birth
Verified date | February 2010 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Medicines Control Council |
Study type | Interventional |
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 immunogenic in a wide range of subjects in previous clinical trials. In this trial,we
will vaccinate 24 children with 5 x 10^7pfu of MVA85A and three groups of 36 infants with
2.5 x 10^7, 5 x 10^7 or 1 x 10^8 pfu.
Participants will be identified from the general population living in Worcester, Western
Cape, South Africa
Status | Completed |
Enrollment | 168 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 11 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | University Cape Town | Worcester | Western Cape |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | University of Cape Town |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of MVA85A. Both local and systemic adverse events will be monitored, including a daily diary card for the first week. Blood will be taken at day 7 and day 28 for biochemistry and haematology. | 3 months | Yes | |
Secondary | Immunogenicity of MVA85A | 3 months | No |
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