Ad5Ag85A*
Candidate Overview
Ad5Ag85A is a human adenovirus serotype 5-vectored vaccine expressing Antigen 85A (Ag85A). This vaccine is delivered by the inhaled aerosol route.
Sponsor / Lead Developer: McMaster University
Primary Indication: Prevention of TB disease
Other Indication(s): Prevention of Mtb infection or sustained infection and Prevention of TB recurrence
Target Population(s): Adolescents and Adults
Target Route of Administration: Aerosol
Clinical Trials
COMPLETED TRIALS |
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| Registry Number | NCT02337270 |
| Clinical Trial Phase | Phase 1 |
| Clinical Trial Sponsor | McMaster University |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| Results/Publication> | Aerosol delivery, but not intramuscular injection, of adenovirus-vectored tuberculosis vaccine induces respiratory-mucosal immunity in humans (JCI Insight, 2022) |
Related Publications
- Induction of an Immune-Protective T-Cell Repertoire With Diverse Genetic Coverage by a Novel Viral-Vectored Tuberculosis Vaccine in Humans (J Infect Dis, 2016)
- AdHu5Ag85A Respiratory Mucosal Boost Immunization Enhances Protection against Pulmonary Tuberculosis in BCG-Primed Non-Human Primates (PLOS ONE, 2015)
- A Human Type 5 Adenovirus–Based Tuberculosis Vaccine Induces Robust T Cell Responses in Humans Despite Preexisting Anti-Adenovirus Immunity (Sci Transl Med, 2013)
Additional Information
This viral-vectored vaccine has completed two phase 1 clinical trials, demonstrating potent induction of tissue resident airway immunity following a single inhaled aerosol dose. This vaccine is being utilized in a submitted EDCTP phase 2 trial to expand its footprint to Africa.