A Clinical Trial of Immunobridging and Lot-to-lot Consistency of COVID-19 Vaccine (Ad5-nCoV) in Different Age Groups.

Summary

The study is a single-center, randomized and double-blinded trial to evaluate the immunobridging between different manufacture scales, lot-to-lot consistency of the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)(Ad5-nCOV) in population 6-59 years of age. The immunobridging between different manufacture scales will be evaluated first, the immunobridging between different age groups will be evaluated second, the lot-to-lot consistency will be evaluated at last.

Timeline

Start

2021-06-03

Primary completion

2022-07-31

Completion

2022-07-31

Publications

• Wu YF, Wei MW, Wang RJ, Guo XL, Pan HX, Gao YC, Li XL, Wang X, Ma XM, Wan P, Zhou L, Zhu YW, Li JX, Zhu FC. Immunogenicity consistency and safety with different production scales of recombinant adenovirus type-5 vectored COVID-19 vaccine in healthy adults: a randomized, double-blinded, immunobridging trial. Expert Rev Vaccines. 2023 Jan-Dec;22(1):662-670. doi: 10.1080/14760584.2023.2234997.

Drugs

Indications