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Recruiting NCT06843317

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

Phase I Interventional RSV Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Candidate vaccine, SCB-1019T, AREXVY, placebo.
Who it may be relevant to
Registry conditions: RSV Infection. Basic parameters: 60 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

  • 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™.
  • Biological AREXVY
    positive comparator
  • Other placebo
    Placebo Comparator

Primary outcome measures

  • To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine [Time frame: Within 7 days after vaccination]
  • To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine [Time frame: 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]

Eligibility criteria

Inclusion criteria

  • Male and female participants 60-85 years of age at the screening visit and who received AREXVY before.
  • Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
  • Individuals willing and able to give an informed consent, prior to screening.
  • 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

  • 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.
  • Recurrent or un-controlled neurological disorders or seizures.
  • Serious or unstable chronic illnesses
  • Any history of dementia or any medical condition that moderately or severely impairs cognition
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 5 centers
  • AMR Phoenix — Phoenix
  • AMR Fort Myers — Fort Myers
  • AMR Lexington — Lexington
  • AMR Kansas City — Kansas City
  • Knoxville — Knoxville

Identifiers

NCT: NCT06843317 · CLO-SCB-1019-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗