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.

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.

Study Overview

• Status: Completed
• Conditions: Poliomyelitis
• Intervention / Treatment: Biological: Three doses of low-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 high-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 control sIPV, vaccinated within one-month interval between doses

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Pizhou, Jiangsu, China, 221300
      • Pizhou Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dosage experimental group; Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses	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
Experimental: Medium-dosage experimental group; Three doses of medium-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; Antigen content: 15, 45, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
Experimental: High-dosage experimental group; Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses	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
Active Comparator: Control wIPV group; Three doses of control wIPV, vaccinated within one-month interval between doses	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
Active Comparator: Control sIPV group; Three doses of control sIPV, vaccinated within one-month interval between doses	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd
• Investigators: Principal Investigator: Yuemei Hu, Bachelor, Jiangsu Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2019
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Poliomyelitis
• Other Study ID Numbers: PRO-sIPV-1001-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No