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Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Single-dose regimen of high dosage investigational sIPV
Single-dose regimen of medium dosage investigational sIPV
Three-dose regimen of high dosage investigational sIPV
Three-dose regimen of medium dosage investigational sIPV
Three-dose regimen of low dosage investigational sIPV
Three-dose regimen of commercialized sIPV
Three-dose regimen of commercialized IPV
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis focused on measuring Sabin strain, Inactivated poliovirus vaccine, poliomyelitis, safety, immunogenicity, infant

Eligibility Criteria

2 Months - 49 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old;
  • Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
  • Proven legal identity;
  • Participants (≥ 18 years old), or guardians of the participants (< 18 years old) should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
  • Complying with the requirement of the study protocol;
  • Axillary temperature ≤ 37.0 °C;

Exclusion Criteria:

  • Breast feeding, pregnant, or expected to conceive in the next 60 days;
  • History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
  • Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
  • Autoimmune disease or immunodeficiency/immunosuppressive;
  • serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;
  • severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
  • History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen;
  • Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
  • Long term history of alcoholism or drug abuse;
  • Receipt of any of the following products:

    1. Any subunit or inactivated vaccine within the past 7 day;
    2. Any live attenuated vaccine within the past 14 days;
    3. Any other investigational medicine(s) within the past 30 days;
    4. Any blood product within the past 3 months;
    5. Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within the past 6 month prior to study entry;
  • Acute illness or acute exacerbation of chronic disease within the past 7 days;
  • Axillary temperature > 37.0 °C;
  • Infant participants with prior vaccination of poliovirus;
  • Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;

Sites / Locations

  • Pizhou City Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Phase I Adult Group - High dosage

Phase I Adult Group - Medium dosage

Phase I Child Group - High dosage

Phase I Child Group - Medium dosage

Phase I Infant Group - High dosage

Phase I Infant Group - Medium dosage

Phase I Infant Group - Low dosage

PhaseⅡExperimental Group - High dosage

PhaseⅡExperimental Group - Medium dosage

PhaseⅡExperimental Group - Low dosage

PhaseⅡControl Group -commercialized sIPV

PhaseⅡ Control Group -commercialized IPV

Arm Description

Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; Intervention: Single-dose regimen of high dosage investigational sIPV

Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; Intervention: Single-dose regimen of medium dosage investigational sIPV

Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; Intervention: Single-dose regimen of high dosage investigational sIPV

Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; Intervention: Single-dose regimen of medium dosage investigational sIPV

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention:Three-dose regimen of commercialized sIPV

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV

Outcomes

Primary Outcome Measures

The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen
Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen
GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.
The geometric mean fold increase (GMI) of each group after three-dose regimen
The GMI is the increase of post-immune GMT from pre-immune GMT.

Secondary Outcome Measures

The incidences of solicited adverse events (AEs) of each group in both phase I and II trials
Solicited AEs occurred within 7 days after each injection will be collected.
The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials
Unsolicited AEs occurred within 30 days after each injection will be collected.
The incidences of serious adverse events (SAEs) of each group in both phase I and II trials
SAEs occurred within 30 days after each injection will be collected.

Full Information

First Posted
December 5, 2016
Last Updated
July 25, 2017
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02985320
Brief Title
Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
Official Title
A Open-label Phase I Study to Evaluate Safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Adults, Children, and Infants, and a Blinded, Randomized and Controlled Phase II to Evaluate Safety and Immunogenicity of it in Infants
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.
Detailed Description
This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
Sabin strain, Inactivated poliovirus vaccine, poliomyelitis, safety, immunogenicity, infant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
708 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase I Adult Group - High dosage
Arm Type
Experimental
Arm Description
Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; Intervention: Single-dose regimen of high dosage investigational sIPV
Arm Title
Phase I Adult Group - Medium dosage
Arm Type
Experimental
Arm Description
Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; Intervention: Single-dose regimen of medium dosage investigational sIPV
Arm Title
Phase I Child Group - High dosage
Arm Type
Experimental
Arm Description
Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; Intervention: Single-dose regimen of high dosage investigational sIPV
Arm Title
Phase I Child Group - Medium dosage
Arm Type
Experimental
Arm Description
Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; Intervention: Single-dose regimen of medium dosage investigational sIPV
Arm Title
Phase I Infant Group - High dosage
Arm Type
Experimental
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV
Arm Title
Phase I Infant Group - Medium dosage
Arm Type
Experimental
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV
Arm Title
Phase I Infant Group - Low dosage
Arm Type
Experimental
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV
Arm Title
PhaseⅡExperimental Group - High dosage
Arm Type
Experimental
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV
Arm Title
PhaseⅡExperimental Group - Medium dosage
Arm Type
Experimental
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV
Arm Title
PhaseⅡExperimental Group - Low dosage
Arm Type
Experimental
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV
Arm Title
PhaseⅡControl Group -commercialized sIPV
Arm Type
Active Comparator
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention:Three-dose regimen of commercialized sIPV
Arm Title
PhaseⅡ Control Group -commercialized IPV
Arm Type
Active Comparator
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV
Intervention Type
Biological
Intervention Name(s)
Single-dose regimen of high dosage investigational sIPV
Intervention Description
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Intervention Type
Biological
Intervention Name(s)
Single-dose regimen of medium dosage investigational sIPV
Intervention Description
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Intervention Type
Biological
Intervention Name(s)
Three-dose regimen of high dosage investigational sIPV
Intervention Description
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Intervention Type
Biological
Intervention Name(s)
Three-dose regimen of medium dosage investigational sIPV
Intervention Description
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Intervention Type
Biological
Intervention Name(s)
Three-dose regimen of low dosage investigational sIPV
Intervention Description
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Intervention Type
Biological
Intervention Name(s)
Three-dose regimen of commercialized sIPV
Intervention Description
The control vaccine was manufactured by Chinese Academy of Medical Sciences.
Intervention Type
Biological
Intervention Name(s)
Three-dose regimen of commercialized IPV
Intervention Description
The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
Primary Outcome Measure Information:
Title
The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen
Description
Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
Time Frame
90 days
Title
The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen
Description
GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.
Time Frame
90 days
Title
The geometric mean fold increase (GMI) of each group after three-dose regimen
Description
The GMI is the increase of post-immune GMT from pre-immune GMT.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
The incidences of solicited adverse events (AEs) of each group in both phase I and II trials
Description
Solicited AEs occurred within 7 days after each injection will be collected.
Time Frame
7 days
Title
The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials
Description
Unsolicited AEs occurred within 30 days after each injection will be collected.
Time Frame
30 days
Title
The incidences of serious adverse events (SAEs) of each group in both phase I and II trials
Description
SAEs occurred within 30 days after each injection will be collected.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old; Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators; Proven legal identity; Participants (≥ 18 years old), or guardians of the participants (< 18 years old) should be capable of understanding the written consent form, and such form should be signed prior to enrolment; Complying with the requirement of the study protocol; Axillary temperature ≤ 37.0 °C; Exclusion Criteria: Breast feeding, pregnant, or expected to conceive in the next 60 days; History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc; Congenital malformation, developmental disorders, genetic defects, or severe malnutrition; Autoimmune disease or immunodeficiency/immunosuppressive; serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc; severe nervous system disease (epilepsy, seizures or convulsions) or mental illness; History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen; Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy; Long term history of alcoholism or drug abuse; Receipt of any of the following products: Any subunit or inactivated vaccine within the past 7 day; Any live attenuated vaccine within the past 14 days; Any other investigational medicine(s) within the past 30 days; Any blood product within the past 3 months; Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within the past 6 month prior to study entry; Acute illness or acute exacerbation of chronic disease within the past 7 days; Axillary temperature > 37.0 °C; Infant participants with prior vaccination of poliovirus; Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuemei Hu
Organizational Affiliation
Jiangsu Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pizhou City Center for Disease Control and Prevention
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221300
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30249424
Citation
Chu K, Ying Z, Wang L, Hu Y, Xia J, Chen L, Wang J, Li C, Zhang Q, Gao Q, Hu Y. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: A phase II, randomized, dose-finding trial. Vaccine. 2018 Oct 29;36(45):6782-6789. doi: 10.1016/j.vaccine.2018.09.023. Epub 2018 Sep 21.
Results Reference
derived

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Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine

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