A Trial Evaluate the Immunogenicity and Safety of Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell)

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.

Timeline

Start

2022-11-07

Primary completion

2023-07-30

Completion

2023-09-30

Publications

• Li D, Duan M, Wang X, Gao P, Zhao X, Xu K, Gao GF. Neutralization of BQ.1, BQ.1.1, and XBB with RBD-Dimer Vaccines. N Engl J Med. 2023 Mar 23;388(12):1142-1145. doi: 10.1056/NEJMc2216233. Epub 2023 Mar 1. No abstract available.

Drugs

Indications