RECRUITING

Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed.

Official Title

A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Tolerability and Immunogenicity of SCB-1019T in Adults Who Were Vaccinated With AREXVY at Least 18 Months Before

Quick Facts

Study Start:2025-03-21

Study Completion:2026-06-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06843317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male and female participants 60-85 years of age at the screening visit and who received AREXVY before. 2. Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures. 3. Individuals willing and able to give an informed consent, prior to screening. 4. Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included (a stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment).	1. Acute disease or fever (≥38°C) at time of vaccination. Participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled within the allowed time-window. 2. Recurrent or un-controlled neurological disorders or seizures. 3. Serious or unstable chronic illnesses 4. Any history of dementia or any medical condition that moderately or severely impairs cognition 5. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.

Inclusion Criteria

Exclusion Criteria

1. Male and female participants 60-85 years of age at the screening visit and who received AREXVY before.
2. Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
3. Individuals willing and able to give an informed consent, prior to screening.
4. Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included (a stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment).

1. Acute disease or fever (≥38°C) at time of vaccination. Participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled within the allowed time-window.
2. Recurrent or un-controlled neurological disorders or seizures.
3. Serious or unstable chronic illnesses
4. Any history of dementia or any medical condition that moderately or severely impairs cognition
5. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.

Contacts and Locations

Study Contact

Xuesong Pei, MD

CONTACT

(+86) 18515445890

xuesong.pei@cloverbiopharma.com

Study Locations (Sites)

Knoxville

Knoxville, Tennessee, 37909

United States

Collaborators and Investigators

Sponsor: Clover Biopharmaceuticals USA, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-21

Study Completion Date2026-06-03

Study Record Updates

Study Start Date2025-03-21

Study Completion Date2026-06-03

Terms related to this study

Additional Relevant MeSH Terms

RSV Infection