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Study of the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Tuberculosis | Biological: Ad5Ag85A | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine |
- Local and systemic signs and symptoms and laboratory toxicity [ Time Frame: 24 weeks ]
- Immunogenicity will be compared among the groups by determining the level and quantity of antigen-specific T cells by human interferon ELISA and Elispot assay [ Time Frame: 24 weeks ]
| Estimated Enrollment: | 48 |
| Study Start Date: | June 2009 |
| Study Completion Date: | July 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lower dose
Lower dose of Ad5Ag85A: 10^8pfu
|
Biological: Ad5Ag85A
Single intra-muscular administration of 10^8 pfu of recombinant-deficient human adenoviral TB vaccine (Ad5Ag85A)
|
|
Experimental: Higher dose
Higher dose of vaccine Ad5Ag85A: 10^9pfu
|
Biological: Ad5Ag85A
Single intra-muscular administration of 10^9 recombinant-deficient human adenoviral TB vaccine (Ad5Ag85A)
|
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 present BCG vaccine is needed.
The general objectives of our TB vaccine research program are to develop a safe and effective vaccine for persons who at increased risk of contracting TB or reactivating latent tuberculosis and develop a safe booster vaccine for persons who have been previously vaccinated with BCG.
This is an open-labeled phase 1 single institution trial investigating a recombinant genetic TB vaccine AdAg85A given by intramuscular injection in healthy subjects with or without a history of BCG vaccination. Ad5Ag85A is a recombinant replication-deficient adenoviral vector expressing an M. tuberculosis immunogenic antigen Ag85A. We have shown that it is safe, immunogenic and associated with enhanced protection against challenge with virulent M Tb in murine, bovine and guinea pig models. Clinical grade AdAg85A has been manufactured by the Robert E Fitzhenry Vector Laboratory, Centre for Gene Therapeutics, McMaster University, Hamilton, Ontario, Canada.
The effect of pre-existing adenovirus antibodies on the safety and immunogenicity of the recombinant AdTB vaccine will be evaluated and the results of the PPD skin test following vaccination evaluated in a subset of subjects with a history of a negative PPD skin test.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00800670
| Canada, Ontario | |
| McMaster University Medical Centre | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Principal Investigator: | Zhou Xing, PhD | McMaster University |
| Principal Investigator: | Fiona M Smaill, MD | McMaster University |
More Information
| Responsible Party: | Fiona Smaill, Professor and Chair, McMaster University |
| ClinicalTrials.gov Identifier: | NCT00800670 History of Changes |
| Other Study ID Numbers: |
REB 09-001 |
| Study First Received: | December 1, 2008 |
| Last Updated: | August 6, 2013 |
Keywords provided by Fiona Smaill, McMaster University:
|
tuberculosis vaccine adenovirus |
Additional relevant MeSH terms:
|
Tuberculosis Adenoviridae Infections Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
DNA Virus Infections Virus Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 27, 2017