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

This study has been completed.
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Pauline Verdijk, Institute of Public Health and the Environment
ClinicalTrials.gov Identifier:
NCT01708720
First received: October 15, 2012
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Poliomyelitis
 Drug: IPV
Drug: Sabin-IPV
Drug: Adjuvanted Sabin-IPV
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute for Public Health and the Environment (RIVM):

Primary Outcome Measures:
  • Number of adverse reactions following vaccination [ Time Frame: 4 days or until adverse reactions have resolved ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Level of virus neutralizing titers in serum [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 49 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708720

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

Publications:

Responsible Party: Pauline Verdijk, Clinical Research Scientist, Institute of Public Health and the Environment
ClinicalTrials.gov Identifier: NCT01708720     History of Changes
Other Study ID Numbers: NVI-256A, 2010-024581-22
Study First Received: October 15, 2012
Last Updated: October 18, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by National Institute for Public Health and the Environment (RIVM):
Vaccination
Inactivated Poliomyelitis Vaccine
Polio
Sabin

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on June 17, 2013