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A Phase I, Open-label, Dose-Escalation, Single Site study to Evaluate the Safety, Tolerability, and Immunogenicity of a PIKA-Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine in Healthy Individuals Aged 18-65 Years Old.

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Trial Profile

A Phase I, Open-label, Dose-Escalation, Single Site study to Evaluate the Safety, Tolerability, and Immunogenicity of a PIKA-Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine in Healthy Individuals Aged 18-65 Years Old.

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 17 Jun 2024

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At a glance

  • Drugs YS SC2 010 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man
  • Sponsors LakeShore Biopharma; Yisheng Biopharma

    • Most Recent Events

    • 24 May 2024 According to a YS Biopharma media release, YS Biopharma company name changed to LakeShore Biopharma.
    • 14 Mar 2023 According to a YS Biopharma media release, the Yisheng Biopharma merged with Summit Healthcare Acquisition Corp and the combine company is named as YS Biopharma.
    • 10 Aug 2021 According to a YishengBio media release, it received IND clearance for PIKA recombinant COVID-19 vaccine (CHO cell, S Protein) to conduct Phase I clinical trial from New Zealand Medicines and Medical Devices Safety Authority ("MEDSAFE"), which was following a similar IND approval by the United Arab Emirates Ministry of Health & Prevention.
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