Trials / Unknown
UnknownNCT05522829
A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine SCTV01E-1 in Population Aged Above 18 Years
A Randomized, Double-blind Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E-1 (Alpha/Beta/Delta/Omicron (BA.1/BA.4/BA.5) Variants S-Trimer COVID-19 Vaccine) in Population Aged 18 Years and Older
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Sinocelltech Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The study is a randomized, double-blind Phase II study. It will evaluate the immunogenicity and safety of SCTV01E-1. Approximately 400 participants aged 18 years and older will be enrolled in this study. 160 participants who have not been vaccinated with any COVID-19 vaccine will be enrolled in Cohort 1 and randomly assigned to receive SCTV01E-1 or SCTV01E in a ratio of 1:1. 240 participants who were fully vaccinated with 2 or 3 doses of inactivated COVID-19 vaccines at least three months ago will be enrolled in Cohort 2 and randomly assigned to receive SCTV01E-1 or SCTV01E in a ratio of 1:1.
Detailed description
The study is a randomized, double-blind Phase II study. It will evaluate the immunogenicity and safety of SCTV01E-1. Approximately 400 participants aged 18 years and older will be enrolled in this study. 160 participants who have not been vaccinated with any COVID-19 vaccine will be enrolled in Cohort 1 and randomly assigned to the Group SCTV01E-1 and Group SCTV01E in a ratio of 1:1. All participants will receive 3 doses of vaccinations: Vaccination 1 on D0, Vaccination 2 on D28 and Vaccination 3 on D150. Participants in Group SCTV01E-1 will receive 3 doses of SCTV01E-1, and participants in Group SCTV01E will receive 3 doses of SCTV01E. 240 participants who were fully vaccinated with 2 or 3 doses of inactivated COVID-19 vaccines at least three months ago will be enrolled in Cohort 2 and randomly assigned to Group SCTV01E-1 and Group SCTV01E in a ratio of 1:1. All participants will receive 2 doses of vaccinations: Vaccination 1 on D0 and Vaccination 2 on D120. Participants in Group SCTV01E-1 will receive 2 doses of SCTV01E-1, and participants in Group SCTV01E will receive 2 doses of SCTV01E.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SCTV01E-1 on D0 | Day 0; intramuscular injection |
| BIOLOGICAL | SCTV01E-1 on D28 | Day 28; intramuscular injection |
| BIOLOGICAL | SCTV01E-1 on D150 | Day 150; intramuscular injection |
| BIOLOGICAL | SCTV01E on D0 | Day 0; intramuscular injection |
| BIOLOGICAL | SCTV01E on D28 | Day 28; intramuscular injection |
| BIOLOGICAL | SCTV01E on D150 | Day 150; intramuscular injection |
| BIOLOGICAL | SCTV01E-1 on D120 | Day 120; intramuscular injection |
| BIOLOGICAL | SCTV01E on D120 | Day 120; intramuscular injection |
Timeline
- Start date
- 2022-10-15
- Primary completion
- 2022-12-15
- Completion
- 2023-12-15
- First posted
- 2022-08-31
- Last updated
- 2022-08-31
Source: ClinicalTrials.gov record NCT05522829. Inclusion in this directory is not an endorsement.