Study of the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine
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|ClinicalTrials.gov Identifier: NCT00800670|
Recruitment Status : Terminated (Study was terminated after the low dose cohort had been enrolled)
First Posted : December 2, 2008
Last Update Posted : September 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Biological: Ad5Ag85A||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||July 2013|
Experimental: Lower dose
Lower dose of Ad5Ag85A: 10^8pfu
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
Single intra-muscular administration of 10^9 recombinant-deficient human adenoviral TB vaccine (Ad5Ag85A)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800670
|McMaster University Medical Centre|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Zhou Xing, PhD||McMaster University|
|Principal Investigator:||Fiona M Smaill, MD||McMaster University|