Clinical trial NCT01708720: Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults
Official title: Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Poliomyelitis
Keywords: Vaccination
Inactivated Poliomyelitis Vaccine
Polio
Sabin
Lead sponsor: National Institute for Public Health and the Environment (RIVM)
Sponsor class: OTHER_GOV
Collaborators: name: World Health Organization
First posted: 2012-10-17
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse reactions following vaccination
timeFrame: 4 days or until adverse reactions have resolved
Secondary outcomes:
measure: Level of virus neutralizing titers in serum
timeFrame: 28 days
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Szpital Internistyczny cetrum Badan Farmakologii Klinicznej Monipol Sp. z o.o.
Study officials:
affiliation: Institute for Public Health and the Environment
name: Pauline Verdijk, PhD
role: STUDY_DIRECTOR
References:
citation: Bakker WA, Thomassen YE, van't Oever AG, Westdijk J, van Oijen MG, Sundermann LC, van't Veld P, Sleeman E, van Nimwegen FW, Hamidi A, Kersten GF, van den Heuvel N, Hendriks JT, van der Pol LA. Inactivated polio vaccine development for technology transfer using attenuated Sabin poliovirus strains to shift from Salk-IPV to Sabin-IPV. Vaccine. 2011 Sep 22;29(41):7188-96. doi: 10.1016/j.vaccine.2011.05.079. Epub 2011 Jun 7.
citation: Verdijk P, Rots NY, Bakker WA. Clinical development of a novel inactivated poliomyelitis vaccine based on attenuated Sabin poliovirus strains. Expert Rev Vaccines. 2011 May;10(5):635-44. doi: 10.1586/erv.11.51.
citation: Verdijk P, Rots NY, van Oijen MG, Oberste MS, Boog CJ, Okayasu H, Sutter RW, Bakker WA. Safety and immunogenicity of inactivated poliovirus vaccine based on Sabin strains with and without aluminum hydroxide: a phase I trial in healthy adults. Vaccine. 2013 Nov 12;31(47):5531-6. doi: 10.1016/j.vaccine.2013.09.021. Epub 2013 Sep 21.