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

Poliomyelitis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618783
• Other study ID #: PRO-sIPV-1001-1
• Status: Completed
• Phase: N/A
• Start date: July 20, 2019
• Est. completion date: January 10, 2020

Study information

• Verified date: November 2020
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 10, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 2 Months

Eligibility

Inclusion Criteria:

• Participants of the already finished phase 2 clinical trial;
• Subjects who received the three-doses full schedule vaccination required in the phase 2 tril and can provide the backup paired pre-immune and post-immune serum collected in the phase trial;
• Provide written informed consent.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

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
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
China	Pizhou Center for Disease Control and Prevention	Pizhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunity index of seroconversion rate	The seroconversion rates of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2, Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)	One month after three doses of vaccination
Secondary	Immunity index of geometric mean titer (GMT)	The GMT of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2, Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)	One month after three doses of vaccination
Secondary	Immunity index of geometric mean ratio (GMR)	The GMR of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2, Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)	One month after three doses of vaccination
Secondary	Immunity index of seropositivity rate	The seropositivity rate of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2, Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)	One month after three doses of vaccination