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

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.

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