Back to resultsSafety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults
Primary Purpose
Poliomyelitis
Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
IPV
Sabin-IPV
Adjuvanted Sabin-IPV
Sponsored by
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Vaccination, Inactivated Poliomyelitis Vaccine, Polio, Sabin
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
Sites / Locations
- Szpital Internistyczny cetrum Badan Farmakologii Klinicznej Monipol Sp. z o.o.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Sabin-IPV
Adjuvanted Sabin-IPV
IPV
Arm 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
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
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
Outcomes
Primary Outcome Measures
Number of adverse reactions following vaccination
Secondary Outcome Measures
Level of virus neutralizing titers in serum
Full Information
NCT ID
NCT01708720
First Posted
October 15, 2012
Last Updated
February 20, 2014
Sponsor
Pauline Verdijk
Collaborators
World Health Organization
1. Study Identification
Unique Protocol Identification Number
NCT01708720
Brief Title
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
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pauline Verdijk
Collaborators
World Health Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
Vaccination, Inactivated Poliomyelitis Vaccine, Polio, Sabin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sabin-IPV
Arm Type
Experimental
Arm 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 Title
Adjuvanted Sabin-IPV
Arm Type
Experimental
Arm 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 Title
IPV
Arm Type
Active Comparator
Arm 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(s)
IPV
Other Intervention Name(s)
Inactivated poliomyelitis vaccine, Inactivated polio vaccine, Inactivated poliovirus vaccine
Intervention Type
Drug
Intervention Name(s)
Sabin-IPV
Intervention Type
Drug
Intervention Name(s)
Adjuvanted Sabin-IPV
Primary Outcome Measure Information:
Title
Number of adverse reactions following vaccination
Time Frame
4 days or until adverse reactions have resolved
Secondary Outcome Measure Information:
Title
Level of virus neutralizing titers in serum
Time Frame
28 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Verdijk, PhD
Organizational Affiliation
Institute for Public Health and the Environment
Official's Role
Study Director
Facility Information:
Facility Name
Szpital Internistyczny cetrum Badan Farmakologii Klinicznej Monipol Sp. z o.o.
City
Krakow
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21651934
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.
Results Reference
background
PubMed Identifier
21604984
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.
Results Reference
background
PubMed Identifier
24063976
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.
Results Reference
result
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Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults
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