rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older

This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years. It will also compare the cellular anti-mycobacterial immune response of both vaccines in adults older than 60 years and characterize the cellular immune response against RSV nucleoprotein (N) generated by the rBCG-N-RSV vaccine in adults older than 60 years as compared to the response induced by the conventional BCG.

NCT Number	NCT07762014
Lead Sponsor	Biothervax SpA Collaborators: Pharmassist Ltd, Hellenic Pasteur Institute, Sotiria Thoracic Diseases Hospital of Athens
Conditions	Respiratory Syncytial Virus Infection Prevention, Tuberculosis Prevention
Enrollment	200 participants
Start Date	2026-09-07
Primary Completion	2027-09-07 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-13