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

NCT07762014 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-08-13

No results posted yet for this study

Summary

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.

Conditions

  • Respiratory Syncytial Virus Infection Prevention
  • Tuberculosis Prevention

Interventions

BIOLOGICAL

Vaccination with rBCG-N-RSV

Intradermal vaccination with rBCG-N-RSV that expresses the N protein of the respiratory syncytial virus (RSV)

BIOLOGICAL

Vaccination with conventional BCG (BCG-WT)

Intradermal vaccination with conventional BCG (BCG-WT).

Sponsors & Collaborators

  • Pharmassist Ltd

    collaborator INDUSTRY

  • Hellenic Pasteur Institute

    collaborator OTHER

  • Sotiria Thoracic Diseases Hospital of Athens

    collaborator OTHER

  • Biothervax SpA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-07
Primary Completion
2027-09-07
Completion
2027-12-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07762014 on ClinicalTrials.gov