Revaccination with RSVpreF in Immunocompromised Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3 trial, adults 18 and older who are immunocompromised and have varying RSV vaccination histories will receive a single RSVpreF shot. Participants are grouped by prior vaccination status and will be followed for about 12 months, with at least four study visits to a participating site. The study aims to assess safety, tolerability, and the immune response after revaccination at the specified intervals. All participants receive one RSVpreF dose in the study arm, and the trial will gather data to inform optimal revaccination timing. Locations include Kaiser facilities in Los Angeles, operated with Pfizer as the lead sponsor.

Why it matters

Who can join: the full rules

Key Inclusion 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 Exclusion Criteria:

* 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.

Where it's running

• Kaiser Foundation Hospital LAMC
  Los Angeles, California, United States Recruiting
• Kaiser Permanente Los Angeles Medical center
  Los Angeles, California, United States Recruiting
• Kaiser Permanente
  Los Angeles, California, United States Recruiting
• George Washington University
  Washington D.C., District of Columbia, United States Recruiting
• The Hope Clinic of Emory University
  Decatur, Georgia, United States Recruiting
• University of Iowa
  Iowa City, Iowa, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.