Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine

Study Overview
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Brief Summary
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The purpose of this phase I study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18 45 years and 20 children aged 4 years were only administered one dose of sIPV with medium D antigen content. 60 infants aged 2 months (60 90 days) were randomized to receive three doses of sIPV with medium D antigen content, conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety.

Detailed Description
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The purpose of this phase I study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18 45 years and 20 children aged 4 years were only administered one dose of sIPV with medium D antigen content. 60 infants aged 2 months (60 90 days) were randomized to receive three doses of sIPV with medium D antigen content, conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety. The antigen contents of type I, type II and type III polioviruses in the investigational and control vaccines were as follows: medium-dose Sabin IPV (15 DU, 45 DU and 45 DU), control Sabin IPV (30 DU, 32 DU and 45 DU), control Salk IPV (40 DU, 8 DU and 32 DU). All vaccines were in liquid form, 0.5 ml per dose.

Official Title
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A Phase I Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell)

Conditions
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Polio

Intervention / Treatment
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* Biological: sIPV
* Biological: Commercialized sIPV
* Biological: Commercialized IPV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer aged 18 45 years with/without prior vaccination of poliovirus and without any contraindication for vaccination; Healthy volunteer aged 4 years with/without prior vaccination of poliovirus but without booster vaccination and any contraindication for vaccination; Healthy volunteer aged 2 months (60 90 days) without prior vaccination of poliovirus and any contraindication for vaccination; Guardians of the participants 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: Women aged 18 45 years with positive urine pregnancy test, pregnant or lactating women, or women with pregnancy plans within 3 months; Preterm or low birth weight infants; Congenital malformation, developmental disorders, genetic defects, or severe malnutrition; History of polio; Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness; 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; Autoimmune disease or immunodeficiency/immunosuppressive; Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder), or significant bruising or coagulopathy; Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases; Mother of the participant has HIV infection; Acute illness or acute exacerbation of chronic disease within the past 7 days; Had a high fever within the past 3 days (axillary temperature ≥ 38.0°C); Receipt of any subunit or inactivated vaccine within the past 7 day; Receipt of any live attenuated vaccine within the past 14 days; Receipt of any blood product within the past 3 months; Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;

Ages Eligible for Study
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Minimum Age: 60 Days
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Adult Group - Medium dosage<br>One intramuscular injection of the investigational vaccine (0.5 ml); Intervention: one-dose regimen of medium dosage investigational sIPV Intervention: Biological: one-dose regimen of medium dosage investigational sIPV | Biological: sIPV<br>* The Medium dosage sIPV was developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the medium dosage sIPV were 15 DU, 45 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose.<br>|
| Experimental: Experimental Children Group - Medium dosage<br>One intramuscular injection of the investigational vaccine (0.5 ml); Intervention: one-dose regimen of medium dosage investigational sIPV Intervention: Biological: one-dose regimen of medium dosage investigational sIPV | Biological: sIPV<br>* The Medium dosage sIPV was developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the medium dosage sIPV were 15 DU, 45 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose.<br>|
| Experimental: Experimental Infant Group - Medium dosage<br>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 Intervention: Biological: Three-dose regimen of medium dosage investigational sIPV | Biological: sIPV<br>* The Medium dosage sIPV was developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the medium dosage sIPV were 15 DU, 45 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose.<br>|
| Active Comparator: Control Infant Group - commercialized sIPV<br>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 Intervention: Biological: Three-dose regimen of commercialized sIPV | Biological: Commercialized sIPV<br>* The commercialized sIPV was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.The antigen contents of type I, type II and type III polioviruses in the commercialized sIPV were 30 DU, 32 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose.<br>|
| Active Comparator: Control Infant Group - commercialized IPV<br>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: Biological: Three-dose regimen of commercialized IPV | Biological: Commercialized IPV<br>* The commercialized Salk IPV was manufactured by Sanofi Pasteur S.A.The antigen contents of type I, type II and type III polioviruses in the commercialized IPV were 40 DU, 8 DU and 32 DU. The vaccine was in liquid form, 0.5 ml per dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The seroconversion rates (SCRs) of each group 30 days 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. | 28 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The geometric mean titer (GMT) of each group 30 days after three-dose regimen | GMT of each group 28 42 days after three-dose regimen. | 28 42 days | 
| The geometric mean fold increase (GMI) of each group 30 days after three-dose regimen |  | 28 42 days | 
| The number of participants who have adverse reactions divided by the total number of participants |  | 30 days | 
| The number of participants who have adverse events (AEs) divided by the total number of participants. | occurred within 30 days after each injection | 30 day |