Health Trials

Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons

ConditionRespiratory Syncytial Virus (RSV)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

This clinical trial is being done to learn more about how well a vaccine (Arexvy®) for respiratory syncytial virus, also known as RSV, works in people with weakened immune systems. The main questions it aims to answer are:

* Does 1 or 2 doses of Arexvy work better in people with weakened immune systems? * What medical problems do participants have after receiving Arexvy?

Participants with weakened immune systems will:

* Receive 3 study vaccines over the course of 1 year * Keep a diary of symptoms for 7 days after each vaccine * Have 3 in-person follow up study visits for checkups and tests over the course of 1.5 years * Have 6 phone follow up study visits over the course of 1.5 years

Eligibility criteria

Qualifiers

Able to understand and provide informed consent

Willing and able to comply with the requirements and restrictions in the protocol, including study visits and study-related procedures

Medically stable in the opinion of the Investigator at the time of first study vaccination

Life expectancy ≥ 365 days in the opinion of the Investigator at the time of first study vaccination

Disqualifiers

Known history of hypersensitivity to any vaccine or history of a life-threatening reaction to a vaccine

Previous vaccination with any licensed or investigational RSV vaccine

Acute or chronic clinically significant/unstable neurological disease (such as uncontrolled seizures, strokes, Guillain-Barré Syndrome (GBS)

Vaccination with any inactivated, subunit, or split influenza vaccine or COVID-19 vaccine within 14 days prior to first study vaccination, or vaccination with any other licensed or investigational vaccine within 30 days prior to first study vaccination

Trial design

Treatments tested in this trial

  • Arexvy (2 doses total)
  • Arexvy (3 doses total)
  • Arexvy (1 dose total)
  • Placebo

Treatment groups

170 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

GlaxoSmithKline

Collaborator

Source ClinicalTrials.gov