SINOVAC initiates Phase I clinical study for SINOVAC’s hexavalent reassortant rotavirus vaccine

March 30, 2024  Source: drugdu 85

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On March 27, 2024, the oral hexavalent reassortant rotavirus live attenuated rotavirus vaccine (Vero cell), jointly developed by SINOVAC's Beijing Kexing Zhongwei Biotech Co. and Kexing (Dalian) Vaccine Technology Co.

SINOVAC's hexavalent reassortant rotavirus vaccine was approved for entry into the clinic in January 2024. This study is intended to be a single-arm, open design in adults and children, and a randomized, double-blind, placebo-controlled design in infants, to assess the safety and tolerability of the vaccine in adult and pediatric populations, as well as the immunogenicity of the vaccine in healthy infants.

Rotavirus (RV) is a virus of the family Eutheroviridae, whose primary mode of transmission is fecal-oral, with the possibility of respiratory transmission also present, and which primarily infects the epithelial cells of the small intestine, thereby causing cellular damage and diarrhea. Rotavirus gastroenteritis (RVGE) is the leading cause of severe, fatal diarrhea in children under 5 years of age worldwide. Globally, 41 G genotypes and 57 P genotypes of rotaviruses have been identified to date.1 Domestically, the predominantly prevalent RV strains after 2012 were G9P[8], G3P[8], G1P[8], G2P[4], and G4P[8].G9P[8] replaced G3P[8] as the predominant strain in the 2012-2017 period, and by 2018 G9P[8] accounted for 91.56% in 20182-3.

According to the current epidemiological trend of rotavirus in China and the world, in order to meet the demand for prevention and control, SINOVAC's hexavalent reassortant rotavirus vaccine will cover types G1, G2, G3, G4, G9, and P1A[8], which is more broad-spectrum.

SINOVAC is committed to providing high-quality vaccine products for human beings through scientific innovation and continues to expand its product pipeline. At present, a number of products, including bivalent inactivated enterovirus vaccine, adsorbed tetanus vaccine and hexavalent reassortant rotavirus vaccine, have been approved for clinical research, and some of them are in the late stage of research.


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