rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older (NCT07762014) | Clinical Trial Compass
Not Yet RecruitingPhase 2
rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
Greece200 participantsStarted 2026-09-07
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence, intensity, and duration of the local solicited AEs (evolution of the "flare-up") until the generation of the scar
Timeframe: From vaccination through 180 days post-vaccination
2
Occurrence, intensity and duration of unsolicited AEs during the 6-month follow-up.
Timeframe: From vaccination through 180 days post-vaccination
3
Occurrence of AEs during the 6-month follow-up duration.
Timeframe: From vaccination through 180 days post-vaccination
4
Alterations to the hemogram and/or biochemical profile at 30- and 180- days post vaccination compared to pre-vaccination profile
Timeframe: Day 30 and day 180 post-vaccination
5
Production of IFN-γ and IL-2 by T cells upon exposure to purified protein derivative (PPD) mycobacterial antigen via ELISPOT 7 days prior vaccination and 30- and 180-days post vaccination.
Timeframe: Day 30 and day 180 post-vaccination
6
Production of IFN-γ and IL-2 by T cells upon exposure to recombinant RSV nucleoprotein antigen via ELISPOT 7 days prior vaccination and 30- and 180-days post vaccination