A study on the immune response, safety and the occurrence of RSV-associated respiratory tract illness after administration of RSV OA vaccine in adults 60 years and older.

JRCT ID: jRCT2031240140

Registered date:04/06/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Respiratory Syncytial Virus Infections
• Date of first enrollment: 13/08/2024
• Target sample size: 30
• Countries of recruitment: China,Japan,Finland,Japan,South Korea,Japan,Poland,Japan,Spain,Japan,Unite Kingdom,Japan
• Study type: Interventional
• Intervention(s): 1 dose of RSVPreF3 OA investigational vaccine or Placebo (only for participants in China) administered intramuscularly at Day 1

Outcome(s)

Primary Outcome

-RSV-A neutralization titres expressed as group GMT ratio, 1 month after the RSVPreF3 OA investigational vaccine administration.
-RSV-A neutralization titres expressed as group seroresponse rate (SRR) difference, 1 month after the RSVPreF3 OA investigational vaccine administration.
-RSV-B neutralization titres expressed as group GMT ratio, 1 month after the RSVPreF3 OA investigational vaccine administration.
-RSV-B neutralization titres expressed as group SRR difference, 1 month after the RSVPreF3 OA investigational vaccine administration.

Secondary Outcome

-RSV-A and RSV-B neutralization titres expressed as GMT, at baseline, 1 month and 6 months after the RSVPreF3 OA investigational vaccine administration.
-RSV-A and RSV-B neutralization titers expressed as SRR, 1 month and 6 months after the RSVPreF3 OA investigational vaccine administration.
-RSV-A and RSV-B neutralization titres expressed as group GMT ratio, 1 month after the RSVPreF3 OA investigational vaccine administration.
-RSV-A and RSV-B neutralization titres expressed as group SRR difference, 1 month after the RSVPreF3 OA investigational vaccine administration.
-Percentage of participants reporting SAEs after study intervention administration (Day 1) up to study end (Month 6).
-Percentage of participants reporting pIMDs after study intervention administration (Day 1) up to study end (Month 6).
-Percentage of participants reporting SAEs related to study intervention after study intervention administration (Day 1) up to study end (Month 6).
-Percentage of participants reporting pIMDs related to study intervention after study intervention administration (Day 1) up to study end (Month 6).
-Percentage of participants reporting any fatal SAEs after study intervention administration (Day 1) up to study end (Month 6).

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Adult male or female of >-60 YOA at the time of study intervention administration, who live in the community dwelling (CD participants) (see definition of terms for the definition).
-Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., attend regular phone calls/study site visits), ability to access and utilize a phone or other electronic communications).
-Participants who are medically stable in the opinion of the investigator at the time of vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
-Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study specific procedure.

Exclude criteria

Medical Conditions
-History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s)
-Any clinical conditions for which serum samples would be prohibited for transfer to local central lab for testing. These clinical conditions include hepatitis B, hepatitis C, HIV and Syphilis based on medical history and physical examination and laboratory screening tests.
-Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
-Any history of dementia or any medical condition that moderately or severely impairs cognition.
-Recurrent history or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
-Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
-Serious or unstable chronic illness.
-Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant Therapy
-Previous vaccination with RSV vaccine.
-Use of any investigational or non-registered product other than the study intervention(s) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the study period.
-Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID-19 and inactivated/subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study intervention.
-Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
-Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration or planned administration during the study period.
-Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the study intervention administration or planned administration during the study period. For corticosteroids, this will mean prednisone >-20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

Prior/Concurrent Clinical Study Experience
-Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention. Refer to Definition of Terms for the definition of invasive medical device.

Other Exclusion Criteria
-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.
-Bedridden participants.
-Planned move during the study conduct that prohibits participation until study end.
-Participation of any study personnel or their immediate dependents, family, or household members.

Related Information

• Primary Sponsor: Okawa Yasutoshi