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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Poliomyelitis	Drug: IPV; Drug: Sabin-IPV; Drug: Adjuvanted Sabin-IPV	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	45 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Prevention
Official Title:	Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults
Study Start Date :	August 2011
Actual Primary Completion Date :	September 2011
Actual Study Completion Date :	February 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Sabin-IPV; 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	Drug: Sabin-IPV
Experimental: Adjuvanted Sabin-IPV; 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	Drug: Adjuvanted Sabin-IPV
Active Comparator: IPV; 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	Drug: IPV; Other Names: Inactivated poliomyelitis vaccine; Inactivated polio vaccine; Inactivated poliovirus vaccine

Outcome Measures

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Primary Outcome Measures :

1. Number of adverse reactions following vaccination [ Time Frame: 4 days or until adverse reactions have resolved ]

Secondary Outcome Measures :

1. Level of virus neutralizing titers in serum [ Time Frame: 28 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 49 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Locations

Poland
Szpital Internistyczny cetrum Badan Farmakologii Klinicznej Monipol Sp. z o.o.
Krakow, Poland

Sponsors and Collaborators

Pauline Verdijk

World Health Organization

Investigators

Study Director:	Pauline Verdijk, PhD	Institute for Public Health and the Environment

More Information

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Publications of Results:

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.

Other Publications:

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.

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. Review.

Responsible Party:	Pauline Verdijk, Clinical Research Scientist, National Institute for Public Health and the Environment (RIVM)
ClinicalTrials.gov Identifier:	NCT01708720 History of Changes
Other Study ID Numbers:	NVI-256A; 2010-024581-22 ( EudraCT Number )
First Posted:	October 17, 2012
Last Update Posted:	February 21, 2014
Last Verified:	February 2014

Keywords provided by Pauline Verdijk, National Institute for Public Health and the Environment (RIVM):

Vaccination; Inactivated Poliomyelitis Vaccine; Polio; Sabin

Additional relevant MeSH terms:

Poliomyelitis; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Myelitis; Central Nervous System Infections	Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuromuscular Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs