Study on immune persistence of CTN-1V strain rabies vaccine for human

This study is a single-arm, single-center phase IV clinical trial on a rabies vaccine that has been marketed in China. Vero cells and CTN-1V strain are used in the rabies vaccine product. The purpose of this study is to investigate the safety, immunogenicity and immune persistence of this product. 149 participants were enrolled in the study, all of whom were included in the safety analysis set (SS), of which 116 participants were included in the protocol analysis set (PPS), 115 participants were included in the 6-month immune persistence analysis set (IPS6), 111 participants were included in the 12-month immune persistence analysis set IPS12. The results showed that: 1) In SS analysis set, the adverse reactions were mainly manifested as Pyrexia and pain at the vaccination site, the severity of which were mainly grade 1, and were concentrated in 0–3 days after vaccination. No grade 3 or above adverse events and SAE related to the experimental vaccine were observed. 2) In PPS analysis set, the antibody positive conversion rate reached 100% at 14 days after full immunization of the pre-immunized negative population; Antibody GMT (95%CI) was 14.82 (13.00, 16.90). 3) The positive rate of serum neutralizing antibody was 93.91% and GMT was 1.58 IU/ml at 6 months after full immunization. The positive rate of neutralizing antibody was 85.59% and GMT was 1.30 IU/ml at 12 months after immunization. The results of clinical trials showed that the human rabies vaccine prepared with CTN-1V strain and Vero cells as the matrix had good safety, immunogenicity and immune persistence.