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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Adult Group - High dosage | Experimental | 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 |
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| Experimental Children Group - High dosage | Experimental | 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 |
|
| Experimental Infant Group - High dosage | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sIPV | Biological | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fengcai Zhu, Master | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Disease Control and Prevention | Nanjing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32867698 | Derived | Jia S, Tang R, Li G, Hu Y, Liang Q. The effect of maternal poliovirus antibodies on the immune responses of infants to poliovirus vaccines. BMC Infect Dis. 2020 Aug 31;20(1):641. doi: 10.1186/s12879-020-05348-1. |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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|
The number of participants who had adverse events (AEs) divided by the number of all participants |
| 30 days |
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |