Rise

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Karolinska Institutet

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02], Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2025-07-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

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.

Secondary objectives 2

1. To evaluate the reactogenicity of Arexvy by recording the occurrence of solicited adverse events (AEs) in the study participants.
2. To evaluate the safety of Arexvy in terms of the incidence of unsolicited AEs, SAEs/pIMDs and fatal SAEs.

Conditions and MedDRA coding

RSV infection

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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.
2. Individuals who can understand and read Swedish.
3. Individuals who can provide written consent and agree (by written consent) to receive the Arexvy vaccine.
4. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
5. Participants who are medically stable in the opinion of the investigator at the time of first vaccination.
6. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate if considered by the investigator as medically stable.

Exclusion criteria 10

1. Individuals who are medically immunocompromised, less than 2 years since hematopoietic stem cell transplantation (HSCT) or graft-versus-host disease (GVHD), solid-organ transplanted, other immunosuppressive drugs for treatment of cancer and inflammatory mediated or autoimmune conditions, as judged by the Investigator.
2. Individuals who have already received an RSV vaccine dose at any time in the past.
3. Any known or suspected reaction, hypersensitivity or allergies to be exacerbated by any product or component included in the vaccine and trial
4. Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial.
5. Treatment or disease which, according to the investigator, can affect treatment or trial results.
6. Any of the following medical conditions: - Unstable chronic illness - Recurrent or un-controlled neurological disorders or seizures - Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study - Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe - Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study - Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures - History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures
7. Participation in another clinical trial during the study period, or any previous clinical trials with RSV- or hMPV-vaccine or other prophylaxis.
8. Planned move during the study period that will prohibit participating in the study until study end.
9. Participation of any study personnel or their immediate dependents, family or household members as well as any family relations to Sponsor or PI.
10. Co-administration of other vaccines less than 14 days before or after study vaccination. A period of less than 30 days before or after study vaccination applies in the case of Shingrix.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To describe the neutralizing antibody titers against RSV A and B one month after the prime dose (day 31) of Arexvy in study participants 60 65 years old and ≥80 years old.

Secondary endpoints 4

1. Occurrence, intensity and duration of solicited AEs in the study participants at the administration site and solicited systemic AEs with an onset during the 4-day follow-up period after each vaccination.
2. Incidence of unsolicited AEs in the study participants with an onset during the 30 day follow-up period after each vaccination.
3. Incidence of SAEs or pIMDs in the study participants from the day of vaccination until 6 months.
4. Occurrence of any fatal SAEs from day 1 up to study end.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska Institutet

Sponsor organisation

Karolinska Institutet

Address

Nobels Vag 6

City

Solna

Postcode

171 65

Country

Sweden

Scientific contact point

Organisation

Karolinska Institutet

Contact name

Karin Loré

Public contact point

Organisation

Karolinska Institutet

Contact name

Karin Loré

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications