Trials / Unknown
UnknownNCT05928468
The Safety and Immunogenicity Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Vaccine LYB002
To Evaluate the Safety and Immunogenicity Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Trivalent Vaccine (CHO Cell) LYB002 in Chinese Adults 18 Years and Above Completed Three-dose Inactivated COVID-19 Vaccine
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- Sponsor
- Guangzhou Patronus Biotech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the safety, humoral immunogenicity, cellular immunogenicity and immune persistence following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine;
Detailed description
Main Objective 1. To evaluate the safety following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine; 2. To evaluate the humoral immunogenicity following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine; Secondary Objectives To evaluate the immune persistence following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine; For exploratory purposes To evaluate the cellular immunogenicity following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | LYB002V14 | Participants receiving one or two boost doses of LYB002V14 after a three-dose primary series of inactivated COVID-19 vaccine. |
| BIOLOGICAL | LYB002V14A | Participants receiving one or two boost doses of LYB002V14A after a three-dose primary series of inactivated COVID-19 vaccine. |
| BIOLOGICAL | LYB002CA | Participants at 18-59 years old receiving two boost doses of LYB002CA after a three-dose primary series of inactivated COVID-19 vaccine. |
Timeline
- Start date
- 2023-04-25
- Primary completion
- 2023-07-31
- Completion
- 2023-11-30
- First posted
- 2023-07-03
- Last updated
- 2023-07-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05928468. Inclusion in this directory is not an endorsement.