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

Not Applicable

Completed

• Conditions: Poliomyelitis
• Interventions: Biological: Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses; Biological: Three doses of control wIPV, vaccinated within one-month interval between doses; Biological: Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses; Biological: Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses; Biological: Three doses of control sIPV, vaccinated within one-month interval between doses

• Registration Number: NCT04618783
• Lead Sponsor: Sinovac Biotech Co., Ltd

Brief 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.

Study Timeline

• Study Start: 2019-07-20
• Primary Completion: 2019-12-10
• Study Completion: 2020-01-10
• Status Verified: 2020-11
• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Study First Posted: 2020-11-06
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dosage experimental group	Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses	Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses
Control wIPV group	Three doses of control wIPV, vaccinated within one-month interval between doses	Three doses of control wIPV, vaccinated within one-month interval between doses
High-dosage experimental group	Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses	Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses
Medium-dosage experimental group	Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses	Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses
Control sIPV group	Three doses of control sIPV, vaccinated within one-month interval between doses	Three doses of control sIPV, vaccinated within one-month interval between doses

Primary Outcome Measures

Name	Time	Method
Immunity index of seroconversion rate	One month after three doses of vaccination	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)

Secondary Outcome Measures

Name	Time	Method
Immunity index of seropositivity rate	One month after three doses of vaccination	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)
Immunity index of geometric mean titer (GMT)	One month after three doses of vaccination	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)
Immunity index of geometric mean ratio (GMR)	One month after three doses of vaccination	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)

Trial Locations

Locations (1)

Pizhou Center for Disease Control and Prevention; 🇨🇳 Pizhou, Jiangsu, China