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
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
Treatments tested in this trial
- This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65
Treatment groups
65 Participants
are divided into 2 treatment groupsSponsors and collaborators
Karin Karin Loré
Lead sponsor
Karolinska Institutet
Sponsor institution
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov