Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Arexvy (2 doses total)

    Biological/Vaccine

    Arexvy at enrollment, Arexvy at Day 365

  • Arexvy (3 doses total)

    Biological/Vaccine

    Arexvy at enrollment, Day 60, and Day 365

  • Arexvy (1 dose total)

    Biological/Vaccine

    Arexvy at enrollment

  • Placebo

    Other intervention

    Placebo vaccine at day 60

Treatment groups

170 Participants
are divided into 3 treatment groups
Group A: Arm 1: Arexvy + PlaceboExperimental treatment 2 interventions
Group B: Arm 2: Arexvy + ArexvyExperimental treatment 1 intervention
Group C: Arm 3: Healthy ComparatorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Geometric Mean Titer (GMT) (ED60 RSV A and B)

Immune response elicited by adjuvanted RSVPreF3 (Arexvy) in immunocompromised adults as determined by titers of neutralizing antibody estimated dilution 60 (ED60) against RSV A and B

Time frame
At 30 days post 1st and 2nd dose in Arm 1 and Arm 2
2

Immune response elicited by adjuvanted RSVPreF3 (Arexvy) in immunocompromised adults as determined by titers of neutralizing antibody ED60 against RSV A and B

Mean Geometric Increase (MGI): Geometric mean of individual ratio of post-vaccine ED60 of RSV A and B over baseline titer (also called Geometric Mean Fold Rise \[GMFR\])

Time frame
At 30 days post 2nd dose (Arm 2) and 30 days post 1st dose (Arm 1)

Secondary outcomes

1

Proportion of participants reporting reactions at injection site

Solicited local reactions including pain at injection site, erythema, and swelling

Time frame
Within 7 days of study vaccine administration
2

Proportion of participants reporting systemic events

Solicited systemic events including headache, fever, myalgia, arthralgia

Time frame
Within 7 days of study vaccine administration
3

Proportion of participants reporting adverse events

Proportion of participants reporting adverse events

Time frame
Through 30 days after each study vaccine administration
4

Adverse events of special interest

Proportion of participants reporting adverse events of special interest

Time frame
From enrollment to last study visit, approximately 18 months for Arms 1 and 2 and 12 months for Arm 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

GlaxoSmithKline

Collaborator

Source ClinicalTrials.gov
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