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The Immunogenicity and Safety Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Vaccine LYB001

NCT05928455 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-07-03

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the immunogenicity and safety following a heterologous booster dose of recombinant SARS-CoV-2 vaccine (CHO cell) LYB001 in adults 18-59 years of age completed two- or three-dose inactivated COVID-19 vaccine. The main questions it aims to answer are:

* whether LYB001 group is better on immunogenicity than the control group of inactivated vaccine?
* whether LYB001 group has better performance on safety than the control group of inactivated vaccine, such as the lower adverse reaction rate?

Conditions

Interventions

BIOLOGICAL

LYB001

Experimental: The LYB001 vaccine was administered through intramuscular injection at doses of 30ug or 60ug in a 0.5mL volume.

BIOLOGICAL

CoronaVac

Active Comparator: The CoronaVac vaccine was administered through intramuscular injection in a 0.5mL volume.

Sponsors & Collaborators

  • Yantai Patronus Biotech Co., Ltd.

    collaborator INDUSTRY

  • Affiliated Hospital of North Sichuan Medical College

    collaborator OTHER

  • Guangzhou Patronus Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaolan Yong, Bachelor · Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College, Chengdu, China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-14
Primary Completion
2022-10-10
Completion
2023-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT05928455 on ClinicalTrials.gov