Poliomyelitis
Conditions
Keywords
Vaccination, Inactivated Poliomyelitis Vaccine, Polio, Sabin
Brief summary
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
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.
Sponsors
World Health Organization
Pauline Verdijk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse reactions following vaccination | 4 days or until adverse reactions have resolved |
Secondary
| Measure | Time frame |
|---|---|
| Level of virus neutralizing titers in serum | 28 days |
Countries
Poland
Outcome results
None listed