Trials / Unknown
UnknownNCT05616754
A Trial Evaluate the Immunogenicity and Safety of Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell)
Anhui Zhifei Longcom Biologic Pharmacy co. Ltd.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
Summary
The study was designed as a randomized, blind and controlled trial. A total of 300 patients aged 18 and above who were immunized with recombinant novel coronavirus protein vaccine (CHO cell) for more than 4 months (60 patients aged 60 and above) were randomly and blind divided into the experimental group and the control group, and received the experimental vaccine and the control vaccine, respectively. In addition, 100 patients over 4 months after the completion of basic immunization with COVID-19 mRNA vaccine were selected as the open observation group, all of whom received 1 dose of experimental vaccine.
Detailed description
The improved vaccine was developed against the Delta and Omicron COVID-19 variants. The overall design of this clinical trial was as follows: A total of 300 patients aged 18 and above who completed the basic immunization of recombinant novel coronavirus protein vaccine (CHO cell) for more than 4 months were randomly divided into the experimental group and the control group in a blind way, and were inoculated with the experimental vaccine and the control vaccine respectively. In addition, 100 patients over 4 months after the completion of basic immunization with COVID-19 mRNA vaccine were selected as the open observation group, all of whom received 1 dose of experimental vaccine. The main objective was to evaluate the immunogenicity and safety of Omicron-Delta recombinant novel coronavirus protein vaccine (CHO cells) against Omicron variants of novel coronavirus in people aged 18 years and above.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells) | The antigen protein of this product is designed to be expressed in tandem with Delta variant R319-N356 and Omicron variant R319-N356. The antigen is called DO-RBD for short. |
| BIOLOGICAL | Recombinant Novel Coronavirus Protein Vaccine (CHO cells) | This strain was made from the NCP-RBD receptor binding region of the spike glycoprotein of novel coronavirus expressed in recombinant CHO cells, which was purified and added with aluminum hydroxide adjuvant |
Timeline
- Start date
- 2022-11-07
- Primary completion
- 2023-07-30
- Completion
- 2023-09-30
- First posted
- 2022-11-15
- Last updated
- 2022-11-15
Locations
1 site across 1 country: Uzbekistan
Source: ClinicalTrials.gov record NCT05616754. Inclusion in this directory is not an endorsement.