Study of the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine
|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 ]
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|