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Safety and Immunogenicity of Recombinant COVID-19 Trivalent Protein Vaccine （CHO Cell）LYB002V14 in Booster Vaccination

NCT06167915 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-12-26

No results posted yet for this study

Summary

This is a randomized, blinded, and dose escalation phase I trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety and immunogenicity of Recombinant COVID-19 Trivalent (XBB.1+BQ.1.1+Prototype) Protein Vaccine （CHO Cell）（LYB002V14）.

Conditions

Interventions

BIOLOGICAL

30μg dose of LYB002V14

30μg dose of LYB002V14 vaccine IM, on day 0

BIOLOGICAL

60μg dose of LYB002V14

60μg dose of LYB002V14 vaccine IM, on day 0

BIOLOGICAL

placebo

placebo IM, on day 0

Sponsors & Collaborators

  • Yantai Patronus Biotech Co., Ltd.

    collaborator INDUSTRY

  • Guangzhou Patronus Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qin Yu, Master · West China Second University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-26
Primary Completion
2024-12-26
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06167915 on ClinicalTrials.gov