Status:
TERMINATED
Study of the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine
Lead Sponsor:
McMaster University
Conditions:
Tuberculosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this Phase 1 study is to evaluate the safety and immune responses of a new tuberculosis vaccine, Ad5Ag85A, administered to healthy volunteers. 48 subjects will be recruited, 24 who have...
Detailed Description
As the global tuberculosis (TB) epidemic continues, the incidence of latent and active TB is expected to rise. HIV-infected persons are especially susceptible to TB. An improved TB vaccine over the pr...
Eligibility Criteria
Inclusion
- Healthy human subjects who are between 18 and 55 years of age with or without a history of BCG vaccination.
- HIV antibody negative
- For women, negative pregnancy test and practising two acceptable forms of contraception for the duration of the study (barrier contraceptive, birth control pill, surgically sterile, post-menopausal 2yrs, abstinence)
- For men, using barrier contraception for the duration of the study
Exclusion
- Pregnant or lactating women
- Subjects who have any acute or chronic illnesses including active tuberculosis or receiving any drug treatment in the opinion of the investigator likely to affect the immune system.
- Subjects with symptoms suggestive of an upper respiratory tract infection (including cough, runny nose, or sore throat)
- Subjects who have a history of active or latent TB infection or whose PBMCs are strongly responsive to ESAT6/CFP10 stimulation using a commercial interferon gamma release assay for TB \[consistent with latent TB infection\].
- Subjects who have laboratory values outside the normal range.
- Not available for scheduled follow-up visits. Subjects enrolled in the trial must be followed at 7 days, and then at 2, 4, 8, 16 and 24 weeks post-vaccination.
- Failure to provide written consent.
- Known allergy to vaccine components
- Known exposure to active TB within past 6 months or subjects whose occupation puts them at increased risk of TB exposure (based on Hamilton Health Science/St Joseph Healthcare list of high risk personnel)
- Any abnormality on chest x-ray suggestive of active or remote tuberculosis infection.
- PPD skin test within last 12 months
- BCG status unknown
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00800670
Start Date
June 1 2009
End Date
July 1 2013
Last Update
September 8 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5