Immunogenicity and Safety of Sabin-IPV Replacement Vaccination

a Randomized, Controlled Clinical Trial of Immunogenicity and Safety of Sabin-based Inactivated Polio Vaccine Replacing Salk-based Inactivated Polio Vaccine

This study replaced the 2nd and 3rd dose of Salk-IPV (produced by Sanofi) with Sabin-IPV (produced by CNBG) and then reviewed the safety and immunogenicity of the vaccination, aiming to acquire scientific evidence for the feasibility of immunization involving different viral strains replacement.

Study Overview

• Status: Completed
• Conditions: Vaccination
• Intervention / Treatment: Biological: Inactivated Polio Vaccine

Detailed Description

It is required by China Food and Drug Administration (CFDA) that considering in the real situation IPV receivers may be immuned by different viral strains of this vaccine, a phase 4 clinical trial aiming to demonstrate the safety and immunogenicity of the immunization schedule should be carried out. To be specific, the subjects were divided into 2 groups.

Group 1 received Salk-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.

Group 2 received Salk-IPV+Salk-IPV+Salk-IPV respectively at the age of 2,3,4 months old.

Blood sample was collected before vaccination and 30 days after the third dose of vaccination. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will also been monitored.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100013
      • Beijing Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• subjects aged from 60 days to 89 days old at the date of recruitment;
• with informed consent signed by parent(s) or guardians;
• parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
• subjects did not receive any vaccines within 14 days;
• axillary temperature ≤37.0℃

Exclusion Criteria:

• allergic to any ingredient of vaccine or with allergy history to any vaccine;
• acute febrile disease or infectious disease;
• serious chronic diseases;
• any other factor that makes the investigator determines the subject is unsuitable for this study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; 180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Sabin-IPV; 3rd: Sabin-IPV	Biological: Inactivated Polio Vaccine; Inactivated Polio Vaccine at age of 2,3,4 months old, respectively
Active Comparator: group 2; 180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Salk-IPV; 3rd: Salk-IPV	Biological: Inactivated Polio Vaccine; Inactivated Polio Vaccine at age of 2,3,4 months old, respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rate	determine the seroconversion rate of both groups	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutralizing antibody titers	Measure neutralizing antibody titers against poliovirus type I, II and III	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants who experience adverse events	analyse the number and rate of vaccine participants who have adverse events following immunization	6 months

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Peking University; Beijing Institute of Biological Products Co Ltd.; Beijing Center for Disease Control and Prevention
• Investigators: Study Director: Jiang WU, Beijing Center for Disease Control and Prevention

Publications and helpful links

General Publications

• Chen H, Gao Z, Bai S, Liu X, Han S, Xiao Y, Liu F, Yu Y, Sun H, Yang X. Immunogenicity and safety of sabin-strain based inactivated poliovirus vaccine replacing salk-strain based inactivated poliovirus vaccine: An innovative application of different strain-IPVs replacement. Vaccine. 2021 Apr 22;39(17):2467-2474. doi: 10.1016/j.vaccine.2021.02.073. Epub 2021 Mar 31.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): December 28, 2018
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ChinaNBG

Drug and device information, study documents

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