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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Clover Biopharmaceuticals USA, LLC
Study ID
NCT06843317
Phase
PHASE1
Status
Recruiting
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Conditions

  • RSV Infection

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Candidate vaccine, SCB-1019T — BIOLOGICAL
    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™.
  • AREXVY — BIOLOGICAL
    positive comparator
  • placebo — OTHER
    Placebo Comparator

Study Details

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.

Key Dates

Start date
Mar 21, 2025
Status verified
Feb 2025
Primary completion
Mar 3, 2026
Completion
Jun 3, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1 (SCB-1019T)
    50 adults to receive low dose SCB-1019T at Day 1
  • Experimental: Group 2 (SCB-1019T)
    50 adults to receive high dose SCB-1019T at Day 1
  • Active Comparator: Group 3 (AREXVY)
    50 adults to receive AREXVY at Day 1
  • Placebo Comparator: Group 4 (Placebo)
    10 adults to receive Placebo at Day 1

Primary Outcome Measure

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

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
AMR PhoenixPhoenixArizona85282
William Reedy, MD
[email protected]
615-591-0211
AMR Fort MyersFort MyersFlorida33912
Pedro Ylisastigui, MD
[email protected]
615-591-0211
AMR LexingtonLexingtonKentucky40509
Mark Adams, MD
[email protected]
615-591-0211
AMR Kansas CityKansas CityMissouri64114
Martha Sue Fanning, MD
[email protected]
615-591-0211
KnoxvilleKnoxvilleTennessee37909
Jerry B. Punch, MD
[email protected]
615-591-0211

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AMR Phoenix· Phoenix, AZAMR Fort Myers· Fort Myers, FLAMR Lexington· Lexington, KYAMR Kansas City· Kansas City, MOKnoxville· Knoxville, TN

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