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Phase 1, Placebo-controlled, Randomized, Observer-blind, First-in-human Study of Bivalent RSV Prefusion F Protein Vaccines (SCB-1019/SCB-1019T) in Healthy Adults

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Trial Profile

Phase 1, Placebo-controlled, Randomized, Observer-blind, First-in-human Study of Bivalent RSV Prefusion F Protein Vaccines (SCB-1019/SCB-1019T) in Healthy Adults

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 13 Jun 2025

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At a glance

  • Drugs SCB-1019 (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions; First in man
  • Sponsors Clover Biopharmaceuticals

Most Recent Events

  • 06 Jun 2025 Part 1 of the study (18 to 59 years of age) has been removed, the related primary end-points have also been removed. Treatment arms are increased from 10 to 14 by the addition of 4 new arms (2 experimental arms, 1 placebo and 1 active comparator- AREXVY).
  • 06 Jun 2025 Status changed from recruiting to completed.
  • 18 Jun 2024 According to a Clover Biopharmaceuticals Media Release, full Phase 1 clinical readout expected by the end of 2024 to support further development and strengthen our potentially differentiated profile for markets globally.

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