Health TrialsbyHealthPanel

RSV Immunogenicity Study in the Elderly (RISE)

ConditionRSV Immunisation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorKarin Karin Loré

About this trial

Respiratory syncytial virus (RSV) is a common cause of respiratory tract infections leading to hospitalizations in infants and in elderly. Arexvy is an approved vaccine for the prevention of RSV infection, however, data on its efficacy in individuals aged 80 years and older remain limited. This study aims to evaluate potential differences in immune responses to Arexvy vaccination between adults aged ≥80 years and those aged 60-65 years.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female individuals who were born between 1965 and 1960 or 1945 and before, at the time of the first vaccination, who live in the community or in a long-term care facility.

Individuals who can understand and read Swedish.

Individuals who can provide written consent and agree (by written consent) to receive the Arexvy vaccine.

Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

Disqualifiers

Individuals who are medically immunocompromised, less than 2 years since hematopoietic stem cell transplantation (HSCT) or graft-versus-host disease (GVHD), solid-organ transplanted, using immunosuppressive drugs for treatment of cancer and who have inflammatory mediated or autoimmune conditions, as judged by the Investigator.

Individuals who have already received an RSV vaccine dose at any time in the past.

Any known or suspected reaction, hypersensitivity or allergies to be exacerbated by any product or component included in the vaccine and trial.

Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial.

Trial design

Design model

Parallel

Treatments tested in this trial

  • This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65

    Biological/Vaccine

    The RSV vaccine (Arexvy) has demonstrated efficacy against LRTD over three RSV seasons in individuals aged 60 and older, with an acceptable safety and reactogenicity profile. However, data on vaccine responses in individuals aged 80 and older, including frail individuals, remains limited. This population is particularly affected by severe RSV infections, highlighting the need for further investigation to address these gaps.

Treatment groups

65 Participants
are divided into 2 treatment groups
Group A: Individuals of the age of 60 to 65 years old.Active comparator 1 intervention
Group B: Individuals ≥80 years old.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary endpoint:

To assess the neutralizing antibody geometric mean titers (GMTs) against RSV A and B one month after the prime dose (day 31) of Arexvy in study participants aged 60-65 years and ≥80 years old, measured by a neutralization assay. Mean geometric increase (MGI), geometric increase (MGI) between day 0 and day 31 after prime will be calculated (equal to the geometric mean of the individual ratio). A more detailed description can be found in section 10.2.1.

Time frame
Day 31
2

Primary objective

To describe the induction of neutralizing antibodies against RSV A and B following the first dose of Arexvy in older adults aged 80 years and older and those aged 60 to 65 years.

Time frame
Day 31

Secondary outcomes

1

Secondary objective:

To evaluate the reactogenicity of Arexvy by recording the occurrence of solicited adverse events (AEs) in the study participants.

Time frame
Between day 0 to 18 month
2

Secondary objectives

To evaluate the safety of Arexvy in terms of the incidence of unsolicited AEs, SAEs/pIMDs and fatal SAEs.

Time frame
Between day 0 to 18 month
3

Secondary endpoint

Incidence of SAEs, pIMDs, and fatal SAEs among study participants receiving Arexvy.

Time frame
Between day 0 - 18 month
4

Seconda y endpoint

Incidence of unsolicited AEs in the study participants with an onset during the 30 day follow-up period after each vaccination.

Time frame
Between day 0-day 30 after each vaccination

Other outcomes

Sponsors and contacts

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

Karin Karin Loré

Lead sponsor

Karolinska Institutet

Sponsor institution

Karolinska Institutet

Collaborator

Source ClinicalTrials.gov
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