RSV Vaccination in Immunocompromised Patients.
ConditionRSV Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
Respiratory syncytial Virus (RSV) causes respiratory infections worldwide and typically presents with a seasonal pattern peaking in autumn/winter in temperate climate zones. Apart from infants and elderly individuals, patients with underlying substantial respiratory, cardiovascular, endocrinological diseases and immunocompromised patients are at increased risk to develop lower respiratory tract infection (LRTI) requiring intensive care associated with increased mortality. For certain risk groups such as patients after hematologic stem cell transplantation (HSCT) in-hospital mortality may be as high as 70 %. A causally related, RSV specific treatment does not exist and treatment is therefore usually supportive and non-specific.
The study is aiming to determine if immunocompromised patients benefit from two doses of a RSV subunit vaccine as opposed to one dose. The additional dose will be administered off label.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.
Participants who can give written informed consent prior to study entry and performance of any study-specific procedure.
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, post-menopause, premenarche, bilateral oophorectomy, or bilateral salpingectomy
Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception from 1 month prior to first Arexvy vaccination and agreed to continue adequate contraception for at least 1 month after completion of the last study intervention administration, and has a negative pregnancy test on the day of first vaccination prior to vaccine application.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Arexvy powder and suspension for injection
Biological/VaccineArexvy powder and suspension for injection (RSV vaccine)
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Group 1-3 (2 times verum)Experimental treatment 1 intervention
Group B: Group 4 (1 time verum, 1 time placebo, randomised)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To assess the mean geometric increase of RSV-A and RSV-B neutralizing antibodies after second vaccine dose over first vaccine dose with the adjuvanted RSV subunit vaccine Arexvy in immunocompromised patients ≥ 18 YoA.
Fold increase of RSV-A and -B-specific neutralizing titers 30-60 days (V5) after the second dose relative to titers 30-60 days (V3) after the first dose in immunocompromised patients per group.
Time frame
up to 14 months per participantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of Vienna
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov