A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Vir… (NCT07092865) | Clinical Trial Compass
RecruitingPhase 2
A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant
United States, Australia, Canada184 participantsStarted 2025-08-06
Plain-language summary
This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.
Who can participate
Age range
18 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:
* Participants of the RSV OA=ADJ-023 study from the Per Protocol Set (Visit 3 for participants in IC\_1 and Visit 4 for participants in IC\_2 group), who received either 1 or 2 doses of the adjuvanted RSVPreF3 vaccine and for whom the immunogenicity data are available.
* Participants who, can and will comply with the requirements of the protocol (e.g., completion of the paper diary cards (as applicable), return for follow-up visits, ability to access and utilize a phone or other electronic communications, have regular contact to allow evaluation during the study).
* Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
* Female participants of nonchildbearing potential may be enrolled in the study. Non childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause.
* Female participants of childbearing potential may be enrolled in the study if the participant:
* has practiced adequate contraception from 1 month prior to study intervention administration, and
* agreed to continue adequate contraception until 1 month after study intervention, and
* has a negative pregnancy test on the day of and prior to study intervention administration.
* Participant who has received an ABO compatible allogeneic kidney or lung transplant (allograft) more than 12 months (365 days) prior to the study intervention administration.
* Participant receiving…
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
RSV-A neutralizing titers expressed as Geometric mean titers (GMTs)
Timeframe: At Visit 1 (Day 1) of the current study
2
RSV-B neutralizing titers expressed as GMTs
Timeframe: At Visit 1 (Day 1) of the current study
3
RSV-A neutralizing titers expressed as Mean geometric increase (MGI)
Timeframe: At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
4
RSV-B neutralizing titers expressed as MGI
Timeframe: At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
5
RSV-A neutralizing titers expressed as GMTs
Timeframe: At Visit 2 (Day 31) of the current study
6
RSV-B neutralizing titers expressed as GMTs
Timeframe: At Visit 2 (Day 31) of the current study