Testing a Modified BCG Vaccine Against RSV and Tuberculosis in Older Adults

Trial details

Who runs it

Biothervax SpA

Trial code

NCT07762014EU 2023-509048-80-01

Record updated

15 September 2026

Original description

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.Read full original descriptionShow less

Randomized, Double-blind, Phase 2 Clinical Trial Controlled With Conventional Bacillus Calmette-Guérin (BCG) Vaccine to Evaluate the Safety and Immunogenicity of a Recombinant BCG Vaccine That Expresses the Respiratory Syncytial Virus (RSV) Nucleoprotein (N) (rBCG-N-RSV) in Adults Over 60 Years of Age.

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.

Inclusion: Has completed the written informed consent process; Males or females, over 60 years of age as of the date of signature of the informed consent form; Has a stable state of health or controlled (health parameters within the normal range for their disease) chronic diseases that do not fall within the exclusion criteria; Willingness to comply with study procedures; No plans to move to another city in the next 6 months and willing to be contacted by the research team within the study period; Not participate in another research study in the previous 3 months, nor plans to participate in another research study in the next 6 months; Agrees to avoid elective surgery during the study; Willingness to receive HIV test results; Not having received a BCG vaccination within the last 10 years before study vaccination; Exlusion Criteria; Oral temperature ≥37.5°C, axillary ≥37.5°C or tympanic temperature ≥38.0°C in the last 24 hours; Weight less than 50 kg, as well as BMI less than 18.5 or higher than 35 kg/m2; History of treatment or current history of active or latent tuberculosis infection; History of unprotected occupational exposure to an individual with active tuberculosis in a healthcare setting within the past 6 months; Immunosuppressive drugs used within the previous 42 days (inhaled and topical corticosteroids are allowed); Received documented investigational tuberculosis vaccine at any time; Unstable hormonal status, i.e. subjects with any change (dose, formulation, or route) in hormone replacement therapies (including levothyroxine, insulin, estrogen, progesterone etc.) in the last 12 weeks; History or laboratory evidence of any possible past, present, or future immunodeficiency status, including, but not limited to, any laboratory indication of HIV-1 infection; Allergy to BCG vaccine or its components, as well as the existence of contraindications for BCG administration as described in the BCG prescribing information; Previous medical history that may compromise the safety of the study participant, including but not limited to significant impairment of lung function (such as pulmonary diffusion of carbon dioxide <80% or FEV1 ≤80%) due to tuberculosis infection or other pulmonary disease; chronic heart disease with signs of heart failure (NYHA Class II Heart Failure or more) or coronary heart disease, suspicion of progressive neurological disease; uncontrolled epilepsy, liver disease; Administration of attenuated vaccines within 30 days before the start of the study or 14 days for inactivated ones; Having received transfusions or blood products within the 6 months before the start of the study; Uncontrolled hypertension or systolic blood pressure greater than 160 mmHg at the beginning of the study or diastolic greater than 90 mmHg; Active neoplasia; Stage 2 or higher chronic obstructive pulmonary disease; Chronic bronchial asthma with systemic corticosteroids, or with a history of having presented crises that have led to an emergency consultation within the last 2 months; Renal disease with estimated or relative creatinine clearance ≤ 70 ml/min x 1.73 m2; Evidence of a new acute illness that may compromise the safety of the study participant, such as fever (oral or axillary temperature greater than or equal to 37.5°C) or suspicion of active infection; History or laboratory evidence of chronic viral hepatitis; History of alcohol or drug abuse in the last 2 years; Smoking more than 30 cigarettes a day, or cannabis use three or more days a week; History of keloid formation; Congenital diseases of importance, such that they weaken the basal condition of the volunteer; Congenital or acquired absence of the spleen; Coagulation disorders or known thrombocytopenia of less than 100,000 platelets/mm3; Having undergone chemotherapy treatment in the last 6 months; Generalized urticaria in the last 2 months; History of hereditary or acquired angioneurotic edema; Any previous medical condition that the investigator considers may compromise the safety of the subject in the study; Not being available for all study visits (both face-to-face and by telephone) and specific instructions as appropriate (fasting, abstaining from intense physical exercise during the 24 hours before the study visits and during the 72 hours after vaccination); Pregnant women or women of childbearing potential (WOCBP) who are unable or unwilling to utilize appropriate methods of contraception during the study; Breast-feeding women; Male with heterosexual sexual activity with WOCBP who do not agree to use adequate contraception.

ClinicalTrials.gov NCT07762014 · EU CTIS 2023-509048-80-01