Clinical trial for Respiratory Syncytial Virus (RSV)
Official title A Study to Learn About Revaccination With a Vaccine Called RSVpreF in Immunocompromised Adults
ClinicalTrials.gov ID: NCT07768345
What this study is testing
What is RSVpreF Vaccine?
RSVpreF Vaccine is an investigational medicine, being studied as a potential treatment for respiratory syncytial virus (rsv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this phase 3 study is to learn the safety, tolerability and immunogenicity of revaccination with RSVpreF at approximately 1-, 2-, and 3-year intervals to inform the revaccination interval in immunocompromised adults. This study is seeking participants who are 18 years of age and older and will be grouped based on prior RSV vaccination history.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants ≥18 years of age who are/were immunocompromised at the time of initial RSVpreF vaccination, per study protocol, and will be grouped...
- Group 1 will include participants naïve to any RSV vaccine.
- Group 2 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 1 year (9 to 15 months) prior to enrollment.
- Group 3 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 2 years (21 to 27 months) prior to enrollment.
- Group 4 will include participants who previously received 2 doses of RSVpreF in Study C3671023 Substudy B approximately 3 years (36 to 42 months)...
You likely can't join if
- Prior history of any subtype of Guillain-Barré Syndrome (GBS) of any etiology.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any components of the study...
- Participants with a history of transplant rejection, or PTLD, or participants who have had treatment for these conditions, within 90 days prior to...
- Receipt of B-cell depleting therapies within 180 days prior to initial study vaccination. Refer to the study contact for further eligibility details.
See the full eligibility criteria
- Participants ≥18 years of age who are/were immunocompromised at the time of initial RSVpreF vaccination, per study protocol, and will be grouped based on prior RSV vaccination history:
- Group 1 will include participants naïve to any RSV vaccine.
- Group 2 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 1 year (9 to 15 months) prior to enrollment.
- Group 3 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 2 years (21 to 27 months) prior to enrollment.
- Group 4 will include participants who previously received 2 doses of RSVpreF in Study C3671023 Substudy B approximately 3 years (36 to 42 months) prior to enrollment.
- Participants should have a life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment. Key
- Prior history of any subtype of Guillain-Barré Syndrome (GBS) of any etiology.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any components of the study intervention(s).
- Participants with a history of transplant rejection, or PTLD, or participants who have had treatment for these conditions, within 90 days prior to study enrollment or suspected chronic humoral or cellular rejection.
- Receipt of B-cell depleting therapies within 180 days prior to initial study vaccination. Refer to the study contact for further eligibility details.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Decatur, Georgia, United States
- New York, New York, United States
- Rochester, New York, United States
- Durham, North Carolina, United States
- Duncansville, Pennsylvania, United States
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 - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Decatur, Georgia, United States; New York, New York, United States; Rochester, New York, United States; Durham, North Carolina, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.