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.
EU CTIS ID: 2023-509048-80-01
What this study is testing
To evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years. To compare the cellular anti-mycobacterial immune response of both vaccines in adults older than 60 years. To 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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Has completed the written informed consent process
- 2. Males or females, over 60 years of age as of the date of signature of the informed consent form
- 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
- 4. Willingness to comply with study procedures.
- 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.
- 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
You likely can't join if
- 1. Oral temperature ≥37.5°C, axillary ≥37.5°C or tympanic temperature ≥38.0°C in the last 24 hours
- 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.
- 19.History or laboratory evidence of chronic viral hepatitis.
- 2. Weight less than 50 kg, as well as BMI less than 18.5 or greater than 35 kg/m2
- 20.History of alcohol or drug abuse in the last 2 years.
- 21. Smoking more than 30 cigarettes a day, or cannabis use three or more days a week.
See the full eligibility criteria
Who can join
- 1. Has completed the written informed consent process
- 2. Males or females, over 60 years of age as of the date of signature of the informed consent form
- 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
- 4. Willingness to comply with study procedures.
- 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.
- 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
- 7. Agrees to avoid elective surgery during the study
- 8. Willingness to receive HIV test results.
- 9. Not having received a BCG vaccination within the last 10 years before study vaccination.
What rules you out
- 1. Oral temperature ≥37.5°C, axillary ≥37.5°C or tympanic temperature ≥38.0°C in the last 24 hours
- 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.
- 19.History or laboratory evidence of chronic viral hepatitis.
- 2. Weight less than 50 kg, as well as BMI less than 18.5 or greater than 35 kg/m2
- 20.History of alcohol or drug abuse in the last 2 years.
- 21. Smoking more than 30 cigarettes a day, or cannabis use three or more days a week.
- 22.History of keloid formation.
- 23.Congenital diseases of importance, such that they weaken the basal condition of the volunteer.
- 24.Congenital or acquired absence of the spleen.
- 25.Coagulation disorders or known thrombocytopenia of less than 100,000 platelets/mm3.
- 26.Having undergone chemotherapy treatment in the last 6 months.
- 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.
- 27.Generalized urticaria in the last 2 months.
- 28.History of hereditary or acquired angioneurotic edema.
- 29.Any previous medical condition that the investigator considers may compromise the safety of the subject in the study.
- 3. History of treatment or current history of active or latent tuberculosis infection.
- 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).
- 4. History of unprotected occupational exposure to an individual with active tuberculosis in a healthcare setting within the past 6 months.
- 5. Immunosuppressive drugs used within the previous 42 days (inhaled and topical corticosteroids are allowed).
- 6. Received documented investigational tuberculosis vaccine at any time.
- 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.
- 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.
- 11. Administration of attenuated vaccines within 30 days before the start of the study or 14 days for inactivated ones.
- 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.
- 31. Pregnant women or women of childbearing potential (WOCBP) who are unable or unwilling to utilize appropriate methods of contraception during the study.
- 32. Breast-feeding women
- 33. Male with heterosexual sexual activity with women of childbearing potential (WOCBP) who do not agree to use adequate contraception
- 12.Having received transfusions or blood products within the 6 months before the start of the study.
- 13.Uncontrolled hypertension or systolic blood pressure greater than 160 mmHg at the beginning of the study or diastolic greater than 90 mmHg.
- 14.Active neoplasia
- 15.Stage 2 or higher chronic obstructive pulmonary disease.
- 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.
- 17.Renal disease with estimated or relative creatinine clearance ≤ 70 ml/min x 1.73 m2.
The study team makes the final eligibility decision.
Where it's taking place
- Greece
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.