<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01708720</url>
  </required_header>
  <id_info>
    <org_study_id>NVI-256A</org_study_id>
    <secondary_id>2010-024581-22</secondary_id>
    <nct_id>NCT01708720</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults</brief_title>
  <official_title>Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pauline Verdijk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute for Public Health and the Environment (RIVM)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to determine whether the new inactivated polio vaccine that is&#xD;
      based on attenuated poliovirus strains is safe and to evaluate the immune response in healthy&#xD;
      adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted&#xD;
      Sabin-IPV produced with the production process set up for technology transfer by the National&#xD;
      Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine&#xD;
      Institute (NVI).&#xD;
&#xD;
        -  The primary objective is to evaluate safety (local and systemic reactions) of&#xD;
           intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy adults (first&#xD;
           in human).&#xD;
&#xD;
        -  The secondary objective is to evaluate immunogenicity of Sabin-IPV and adjuvanted&#xD;
           Sabin-IPV in healthy immunized adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of adverse reactions following vaccination</measure>
    <time_frame>4 days or until adverse reactions have resolved</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of virus neutralizing titers in serum</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Poliomyelitis</condition>
  <arm_group>
    <arm_group_label>Sabin-IPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adjuvanted Sabin-IPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IPV</intervention_name>
    <arm_group_label>IPV</arm_group_label>
    <other_name>Inactivated poliomyelitis vaccine</other_name>
    <other_name>Inactivated polio vaccine</other_name>
    <other_name>Inactivated poliovirus vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sabin-IPV</intervention_name>
    <arm_group_label>Sabin-IPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adjuvanted Sabin-IPV</intervention_name>
    <arm_group_label>Adjuvanted Sabin-IPV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 49, inclusive at the time of enrolment&#xD;
&#xD;
          -  in good health as determined by the outcome of medical history, physical examination&#xD;
             screening/baseline labs and clinical judgment of the investigator&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Must have received polio vaccinations with OPV according to the Polish National&#xD;
             Immunization Program as a child based on vaccination cards or information given by&#xD;
             subjects during interview with investigator&#xD;
&#xD;
          -  Preferred: number (and date) of polio vaccinations known&#xD;
&#xD;
          -  Willingness and ability to adhere to the study regimen&#xD;
&#xD;
          -  Having a signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IPV or OPV booster dose after the age of 12 years&#xD;
&#xD;
          -  Positive for HIV, Hepatitis B or Hepatitis C&#xD;
&#xD;
          -  Known or suspected allergy against any of the vaccine components&#xD;
&#xD;
          -  History of unusual or severe reactions to any previous vaccination&#xD;
&#xD;
          -  Known or suspected disease or use of medication that may influence the immune system&#xD;
&#xD;
          -  Known or suspected immune deficiency&#xD;
&#xD;
          -  Systemic treatment with corticosteroids within one month before screening&#xD;
&#xD;
          -  Administration of plasma (including immunoglobulins) or blood products three months&#xD;
             prior to the study&#xD;
&#xD;
          -  Blood donation within one month before screening&#xD;
&#xD;
          -  Any vaccination within three months before screening and during the study until the&#xD;
             last visit&#xD;
&#xD;
          -  History of any neurological disorder including epilepsy or febrile seizures&#xD;
&#xD;
          -  Evidence of excessive alcohol use or drug use&#xD;
&#xD;
          -  Any infectious disease at the time of screening and/or inclusion&#xD;
&#xD;
          -  Participation in another clinical trial within three months before screening&#xD;
&#xD;
          -  Abnormal pre-treatment laboratory parameters which are clinically relevant according&#xD;
             to the investigator&#xD;
&#xD;
          -  Bleeding disorders or the usage of anticoagulants&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pauline Verdijk, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Institute for Public Health and the Environment</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Szpital Internistyczny cetrum Badan Farmakologii Klinicznej Monipol Sp. z o.o.</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <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>
    <PMID>21651934</PMID>
  </reference>
  <reference>
    <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>
    <PMID>21604984</PMID>
  </reference>
  <results_reference>
    <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.</citation>
    <PMID>24063976</PMID>
  </results_reference>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>February 20, 2014</last_update_submitted>
  <last_update_submitted_qc>February 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National Institute for Public Health and the Environment (RIVM)</investigator_affiliation>
    <investigator_full_name>Pauline Verdijk</investigator_full_name>
    <investigator_title>Clinical Research Scientist</investigator_title>
  </responsible_party>
  <keyword>Vaccination</keyword>
  <keyword>Inactivated Poliomyelitis Vaccine</keyword>
  <keyword>Polio</keyword>
  <keyword>Sabin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poliomyelitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01708720
org study id: NVI-256A
secondary id: 2010-024581-22
nct id: NCT01708720
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of adverse reactions following vaccination
time frame: 4 days or until adverse reactions have resolved
measure: Level of virus neutralizing titers in serum
time frame: 28 days
arm group label: Sabin-IPV
arm group type: Experimental
description: 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
arm group label: Adjuvanted Sabin-IPV
arm group type: Experimental
description: 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
arm group label: IPV
arm group type: Active Comparator
description: 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
intervention type: Drug
intervention name: IPV
arm group label: IPV
other name: Inactivated poliomyelitis vaccine
other name: Inactivated polio vaccine
other name: Inactivated poliovirus vaccine
intervention type: Drug
intervention name: Sabin-IPV
arm group label: Sabin-IPV
intervention type: Drug
intervention name: Adjuvanted Sabin-IPV
arm group label: Adjuvanted Sabin-IPV
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pauline Verdijk, PhD
role: Study Director
affiliation: Institute for Public Health and the Environment
facility: 
country: Poland
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.
PMID: 21651934
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.
PMID: 21604984
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.
PMID: 24063976
responsible party type: Sponsor-Investigator
investigator affiliation: National Institute for Public Health and the Environment (RIVM)
investigator full name: Pauline Verdijk
investigator title: Clinical Research Scientist
mesh term: Poliomyelitis
mesh term: Vaccines