Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells)

Summary

Popular title: Clinical study of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells). Purpose of the study: Main objectives: To evaluate the immunogenicity and safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (BA.5, BF.7) after vaccination in people aged 18 years and older. Secondary purposes: To evaluate the immune persistence of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (BA.5, BF.7) after vaccination in people aged 18 years and older. Overall design: Studies were randomized, double-blind, active, controlled study design. Study group: people aged 18 years and above who have completed primary immunization or booster immunization of the new coronavirus vaccine for more than 6 months. Study group: Randomly divided into study group and control group according to the 1:1 ratio, of which 225 subjects in the study group and 225 subjects in the control group were vaccinated with study vaccine and control vaccine respectively.

Timeline

Start

2023-03-17

Primary completion

2023-10-17

Completion

2024-03-20

Publications

• Hu H, Ma F, Gong L, Wang Y, Xu M, Sun H, Hu Q, Wang P, Han L, Xie H. Immunogenicity and safety of a recombinant Omicron BA.4/5-Delta COVID-19 vaccine ZF2202-A in Chinese adults. Vaccine. 2024 May 31;42(15):3522-3528. doi: 10.1016/j.vaccine.2024.04.058. Epub 2024 May 3.
• He Q, An Y, Zhou X, Xie H, Tao L, Li D, Zheng A, Li L, Xu Z, Yu S, Wang R, Hu H, Liu K, Wang Q, Dai L, Xu K, Gao GF. Neutralization of EG.5, EG.5.1, BA.2.86, and JN.1 by antisera from dimeric receptor-binding domain subunit vaccines and 41 human monoclonal antibodies. Med. 2024 May 10;5(5):401-413.e4. doi: 10.1016/j.medj.2024.03.006. Epub 2024 Apr 3.

Drugs

Indications