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

NCT04618783 | Completed

• 1 other identifier: PRO-sIPV-1001-1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Immunity index of geometric mean titer (GMT)

  One month after three doses of vaccination

• Immunity index of geometric mean ratio (GMR)

  One month after three doses of vaccination

• Immunity index of seropositivity rate

  One month after three doses of vaccination

Study Arms (5)

Low-dosage experimental group

EXPERIMENTAL

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

Medium-dosage experimental group

EXPERIMENTAL

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

High-dosage experimental group

EXPERIMENTAL

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

Control wIPV group

ACTIVE COMPARATOR

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

Control sIPV group

ACTIVE COMPARATOR

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

Interventions

Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses BIOLOGICAL

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

Low-dosage experimental group

Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses BIOLOGICAL

Antigen content: 15, 45, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Medium-dosage experimental group

Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses BIOLOGICAL

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

High-dosage experimental group

Three doses of control wIPV, vaccinated within one-month interval between doses BIOLOGICAL

Antigen content: 40, 8, and 32 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Control wIPV group

Three doses of control sIPV, vaccinated within one-month interval between doses BIOLOGICAL

Antigen content: 30, 32, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Control sIPV group

Eligibility Criteria

• Age: 2 Months - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Pizhou Center for Disease Control and Prevention

Pizhou, Jiangsu, 221300, China

Location

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Yuemei Hu, Bachelor

  Jiangsu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: July 20, 2019
• Primary Completion: December 10, 2019
• Study Completion: January 10, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)