MYCOBACTERIUM BOVIS BACILLUS CALMETTE-GUÉRIN, STRAIN DANISH 1331, LIVE, EXPRESSING RESPIRATORY SYNCYTIAL VIRUS, NUCLEOPROTEIN for Respiratory syncytial virus infection

Inclusion criteria

• {"criterion_text":"- 1. Has completed the written informed consent process\n- 2. Males or females, over 60 years of age as of the date of signature of the informed consent form\n- 3. 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\n- 4. Willingness to comply with study procedures.\n- 5. 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.\n- 6. Not participate in another research study in the previous 3 months, nor plans to participate in another research study in the next 6 months\n- 7. Agrees to avoid elective surgery during the study\n- 8. Willingness to receive HIV test results.\n- 9. Not having received a BCG vaccination within the last 10 years before study vaccination."}

Exclusion criteria

• {"criterion_text":"- 1. Oral temperature ≥37.5°C, axillary ≥37.5°C or tympanic temperature ≥38.0°C in the last 24 hours\n- 10. 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.\n- 11. Administration of attenuated vaccines within 30 days before the start of the study or 14 days for inactivated ones.\n- 12. Weight less than 50 kg, as well as BMI less than 18.5 or greater than 35 kg/m2\n- 13. Uncontrolled hypertension or systolic blood pressure greater than 160 mmHg at the beginning of the study or diastolic greater than 90 mmHg.\n- 14. Active neoplasia\n- 15. Stage 2 or higher chronic obstructive pulmonary disease.\n- 16. 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.\n- 17. Renal disease with estimated or relative creatinine clearance ≤ 70 ml/min x 1.73 m2.\n- 18. 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.\n- 19. History or laboratory evidence of chronic viral hepatitis.\n- 20. History of alcohol or drug abuse in the last 2 years.\n- 21. Smoking more than 30 cigarettes a day, or cannabis use three or more days a week.\n- 22. History of keloid formation.\n- 23. Congenital diseases of importance, such that they weaken the basal condition of the volunteer.\n- 24. Congenital or acquired absence of the spleen.\n- 25. Coagulation disorders or known thrombocytopenia of less than 100,000 platelets/mm3.\n- 26. Having undergone chemotherapy treatment in the last 6 months.\n- 27. Generalized urticaria in the last 2 months.\n- 28. History of hereditary or acquired angioneurotic edema.\n- 29. Any previous medical condition that the investigator considers may compromise the safety of the subject in the study.\n- 30. 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).\n- 31. Pregnant women or women of childbearing potential (WOCBP) who are unable or unwilling to utilize appropriate methods of contraception during the study.\n- 32. Breast-feeding women\n- 33. Male with heterosexual sexual activity with women of childbearing potential (WOCBP) who do not agree to use adequate contraception\n- 3. History of treatment or current history of active or latent tuberculosis infection.\n- 4. History of unprotected occupational exposure to an individual with active tuberculosis in a healthcare setting within the past 6 months.\n- 5. Immunosuppressive drugs used within the previous 42 days (inhaled and topical corticosteroids are allowed).\n- 6. Received documented investigational tuberculosis vaccine at any time.\n- 7. 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.\n- 8. 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.\n- 9. Allergy to BCG vaccine or its components, as well as the existence of contraindications for BCG administration as described in the BCG prescribing information.\n- 11. Administration of attenuated vaccines within 30 days before the start of the study or 14 days for inactivated ones.\n- 12. Having received transfusions or blood products within the 6 months before the start of the study.\n- 13. Uncontrolled hypertension or systolic blood pressure greater than 160 mmHg at the beginning of the study or diastolic greater than 90 mmHg.\n- 14. Active neoplasia\n- 15. Stage 2 or higher chronic obstructive pulmonary disease.\n- 16. 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.\n- 17. Renal disease with estimated or relative creatinine clearance ≤ 70 ml/min x 1.73 m2.\n- 18. 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."}

Primary endpoints

• {"endpoint_text":"- Occurrence, intensity, and duration of the local solicited AEs (evolution of the \"flare-up\") until the generation of the scar.","definition_or_measurement_approach":"Local solicited adverse events will be recorded (occurrence, intensity, duration) and followed until scar generation (clinical assessment of local reaction evolution)."}
• {"endpoint_text":"- Occurrence, intensity and duration of unsolicited AEs during the 6-month follow-up.","definition_or_measurement_approach":"Recording of unsolicited adverse events over a 6-month follow-up period, including assessments of intensity and duration."}
• {"endpoint_text":"- Occurrence of AEs during the 6-month follow-up duration.","definition_or_measurement_approach":"Monitoring and recording any adverse events occurring during the 6-month follow-up."}
• {"endpoint_text":"- Alterations to the hemogram and/or biochemical profile at 30- and 180- days post vaccination compared to pre-vaccination profile.","definition_or_measurement_approach":"Laboratory evaluation comparing hemogram and biochemical profile at baseline, 30 days and 180 days post-vaccination."}
• {"endpoint_text":"- Production of IFN-γ and IL-2 by T cells upon exposure to purified protein derivative (PPD) mycobacterial antigen 7 days prior vaccination and 30- and 180-days post vaccination.","definition_or_measurement_approach":"Measurement of IFN-γ and IL-2 production by T cells after PPD stimulation at pre-vaccination (7 days prior) and at 30 and 180 days post vaccination (assay methodology not specified here)."}
• {"endpoint_text":"- Production of IFN-γ and IL-2 by T cells upon exposure to recombinant RSV nucleoprotein antigen 7 days prior vaccination and 30- and 180-days post vaccination.","definition_or_measurement_approach":"Measurement of IFN-γ and IL-2 production by T cells after recombinant RSV nucleoprotein stimulation at pre-vaccination (7 days prior) and at 30 and 180 days post vaccination (assay methodology not specified here)."}

Secondary endpoints

• {"endpoint_text":"- Presence and titers of serum IgG antibodies against Purified Protein Derived Mycobacterial antigen (PPD) via ELISA.","definition_or_measurement_approach":"Serum IgG against PPD measured by ELISA; presence and titers assessed (timepoints not restated here)."}
• {"endpoint_text":"- Presence and titers of serum IgG against RSV nucleoprotein via ELISA.","definition_or_measurement_approach":"Serum IgG against RSV nucleoprotein measured by ELISA; presence and titers assessed (timepoints not restated here)."}

Greece

Earliest CTIS Part Ii Submission Date

02-10-2024

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

545

Number Of Sites

2

Number Of Participants

200

Primary sponsor

Full Name

Biothervax SpA

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Chile

Contract research organisations

Name

Pharmassist Ltd.

Responsibilities

sponsorDuties codes: 1,11,12,5,8

Third parties

• {"country":"Greece","full_name":"Hellenic Pasteur Institute","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Educational Institution"}
• {"country":"Greece","full_name":"Biomedical Research Foundation Of The Academy Of Athens","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Greece","full_name":"Pharmassist Ltd.","duties_or_roles":"sponsorDuties codes: 1,11,12,5,8","organisation_type":"Pharmaceutical company"}