Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Phase Ib)

Study Overview
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Brief Summary
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The purpose of this phase Ib 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 high D antigen content. 20 infants aged 2 months (60 90 days) were administered three doses of sIPV with high D antigen content, 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 Ib 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 high D antigen content. 20 infants aged 2 months (60 90 days) were administered three doses of sIPV with high D antigen content, 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 high-dose Sabin IPV were 22 DU, 65 DU and 65 DU. All vaccines were in liquid form, 0.5 ml per dose.

Official Title
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A Phase Ib 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


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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Adult Group - High dosage<br>One intramuscular injection of the investigational vaccine (0.5 ml); Intervention: one-dose regimen of high dosage investigational sIPV Intervention: Biological: one-dose regimen of high dosage investigational sIPV | Biological: sIPV<br>* The investigational High dosage Sabin IPV was all developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the high dosage Sabin IPV were 22 DU, 65 DU and 65 DU. The vaccine was in liquid form, 0.5 ml per dose.<br>|
| Experimental: Experimental Children Group - High dosage<br>One intramuscular injection of the investigational vaccine (0.5 ml); Intervention: one-dose regimen of high dosage investigational sIPV Intervention: Biological: one-dose regimen of high dosage investigational sIPV | Biological: sIPV<br>* The investigational High dosage Sabin IPV was all developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the high dosage Sabin IPV were 22 DU, 65 DU and 65 DU. The vaccine was in liquid form, 0.5 ml per dose.<br>|
| Experimental: Experimental Infant Group - High 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 high dosage investigational sIPV Intervention: Biological: Three-dose regimen of high dosage investigational sIPV | Biological: sIPV<br>* The investigational High dosage Sabin IPV was all developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the high dosage Sabin IPV were 22 DU, 65 DU and 65 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 | 
| 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 | The GMI is the increase of post-immune GMT from pre-immune GMT | 28 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidences of adverse reactions of each group occurred within 30 days after each injection | The number of participants who had adverse reactions divided by the number of all participants | 30 days | 
| The incidences of adverse events (AEs) of each group occurred within 30 days after each injection | The number of participants who had adverse events (AEs) divided by the number of all participants | 30 days |