Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults

Study Overview
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Brief Summary
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The purpose of this trial is to determine whether the new inactivated polio vaccine that is based on attenuated poliovirus strains is safe and to evaluate the immune response in healthy adults.

Detailed Description
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The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV produced with the production process set up for technology transfer by the National Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine Institute (NVI). The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy adults (first in human). The secondary objective is to evaluate immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV in healthy immunized adults.

Official Title
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Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults

Conditions
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Poliomyelitis

Intervention / Treatment
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* Drug: IPV
* Drug: Sabin-IPV
* Drug: Adjuvanted Sabin-IPV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 49, inclusive at the time of enrolment in good health as determined by the outcome of medical history, physical examination screening/baseline labs and clinical judgment of the investigator Male Must have received polio vaccinations with OPV according to the Polish National Immunization Program as a child based on vaccination cards or information given by subjects during interview with investigator Preferred: number (and date) of polio vaccinations known Willingness and ability to adhere to the study regimen Having a signed informed consent form Exclusion Criteria: IPV or OPV booster dose after the age of 12 years Positive for HIV, Hepatitis B or Hepatitis C Known or suspected allergy against any of the vaccine components History of unusual or severe reactions to any previous vaccination Known or suspected disease or use of medication that may influence the immune system Known or suspected immune deficiency Systemic treatment with corticosteroids within one month before screening Administration of plasma (including immunoglobulins) or blood products three months prior to the study Blood donation within one month before screening Any vaccination within three months before screening and during the study until the last visit History of any neurological disorder including epilepsy or febrile seizures Evidence of excessive alcohol use or drug use Any infectious disease at the time of screening and/or inclusion Participation in another clinical trial within three months before screening Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator Bleeding disorders or the usage of anticoagulants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sabin-IPV<br>Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 20, 32, and 64 D-antigen units respectively of Sabin-1,-2 and -3 per dose | Drug: Sabin-IPV<br> <br> |
| Experimental: Adjuvanted Sabin-IPV<br>Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 10, 16, and 32 D-antigen units respectively of Sabin-1,-2 and -3 per dose, adjuvanted with 0.5 mg aluminium hydroxide | Drug: Adjuvanted Sabin-IPV<br> <br> |
| Active Comparator: IPV<br>Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 40, 8, and 32 D-antigen units respectively of Mahoney, MEF-1 and Saukett poliovirus per dose | Drug: IPV<br> <br> * Other names: Inactivated poliovirus vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse reactions following vaccination |  | 4 days or until adverse reactions have resolved | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of virus neutralizing titers in serum |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination, Inactivated Poliomyelitis Vaccine, Polio, Sabin