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

May 13, 2025 updated by: Clover Biopharmaceuticals USA, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study design will compare heterologous revaccination with SCB-1019T, homologous revaccination with AREXVY, or placebo in adults who were previously vaccinated with AREXVY. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85282
        • Recruiting
        • AMR Phoenix
        • Contact:
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • AMR Fort Myers
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Recruiting
        • AMR Lexington
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Recruiting
        • AMR Kansas City
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • Knoxville
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion 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).

Please refer to Protocol for full list of Inclusion and Exclusion criteria.

Exclusion Criteria:

  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.

Please refer to Protocol for full list of Inclusion and Exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (SCB-1019T)
50 adults to receive low dose SCB-1019T at Day 1
Biological: Candidate vaccine, SCB-1019T
SCB-1019T is a novel bivalent recombinant RSV vaccine (CHO Cell) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the PreF protein subunits from the two dominant circulating strains, strain A and strain B, fused to Trimer-Tag™.
Experimental: Group 2 (SCB-1019T)
50 adults to receive high dose SCB-1019T at Day 1
Biological: Candidate vaccine, SCB-1019T
SCB-1019T is a novel bivalent recombinant RSV vaccine (CHO Cell) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the PreF protein subunits from the two dominant circulating strains, strain A and strain B, fused to Trimer-Tag™.
Active Comparator: Group 3 (AREXVY)
50 adults to receive AREXVY at Day 1
Biological: AREXVY
positive comparator
Placebo Comparator: Group 4 (Placebo)
10 adults to receive Placebo at Day 1
Other: placebo
Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Time Frame: Within 7 days after vaccination
Proportion of participants with local and systemic solicited AEs
Within 7 days after vaccination
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Time Frame: Within 28 days after vaccination
Proportion of participants with unsolicited AEs
Within 28 days after vaccination
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Time Frame: Throughout the study period, from enrollment to 6 months follow up
Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
Throughout the study period, from enrollment to 6 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

March 21, 2025

Primary Completion (Estimated)

March 3, 2026

Study Completion (Estimated)

June 3, 2026

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLO-SCB-1019-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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