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

February 20, 2014 updated by: Pauline Verdijk

Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 poliovirus vaccine
  • Inactivated polio vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse reactions following vaccination
Time Frame: 4 days or until adverse reactions have resolved
4 days or until adverse reactions have resolved

Secondary Outcome Measures

Outcome Measure
Time Frame
Level of virus neutralizing titers in serum
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pauline Verdijk

Collaborators

World Health Organization

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (Estimate)

October 17, 2012

Study Record Updates

Last Update Posted (Estimate)

February 21, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVI-256A
  • 2010-024581-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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