NCT04618783

Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization

Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization Against Multiple Individual Wild and Vaccine-derived Polioviruses, Supplementary Study of a Phase 2 Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 2 Months – 2 Months
• Healthy volunteers: Accepted

Summary

This study is a supplementary study of an already finished randomised, double-blinded, and placebo controlled phase 2 clinical trial of an Sabin strain inactivated poliovirus vaccine (sIPV) manufactured by Sinovac Biotech Ltd., Beijing China. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains.

Detailed description

This study is a open-labelled study conducted based on an already finished phase 2 study of the investigational sIPV in 600 healthy infants aged 2-months old. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains. Paired pre-immune and post-immune serum from 250 participants of the phase 2 trial, with 50 in each group including the low-, medium- and high- dosage group, control wild poliovirus vaccine (wIPV) group and control sIPV group, was selected and sent to China Center for Disease Control and Prevention (CDC) for the cross-neutralization assay to determine the neutralizing antibody titer against 10 individual virus strains including Sabin strains (type 1, 2, and 3), Salk strains (Mahoney, MEF-1, and Saukett), cVDPV (type 1, 2, and 3) and Xinjiang wild strain of type 1(Xinjiang wIPV1). All the subjects in this study had been vaccinated at the schedule of month 0,1, and 2 in the phase 2 clinical trial.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses	Antigen content: 7.5, 22.5, and 22.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
BIOLOGICAL	Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses	Antigen content: 15, 45, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
BIOLOGICAL	Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses	Antigen content: 22.5, 67.5, and 67.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
BIOLOGICAL	Three doses of control wIPV, vaccinated within one-month interval between doses	Antigen content: 40, 8, and 32 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
BIOLOGICAL	Three doses of control sIPV, vaccinated within one-month interval between doses	Antigen content: 30, 32, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Timeline

• Start date: 2019-07-20
• Primary completion: 2019-12-10
• Completion: 2020-01-10
• First posted: 2020-11-06
• Last updated: 2020-11-06

Locations

1 site across 1 country: China