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Trial record 10 of 20 for:    Open Studies | "Poliomyelitis"

Phase 1 Study on the Safety and Reactogenicity of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) Given Intramuscularly Compared to Standard Trivalent Inactivated Poliovirus Vaccine (IPV) in Healthy Adults (IPV-004)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01997632
First received: November 22, 2013
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to investigate if the study vaccine, m-IPV2 HD (vaccine that only contains polio serotype 2 in high dose), is as safe as the standard IPV Imovax (that contains the 3 serotypes of polio). This safety evaluation will be done in young adults.

If the study vaccine appears to be safe, it will be tested at a later stage in the target group (infants and children) to evaluate the immunogenicity of the vaccine. After all, the purpose is to use the study vaccine in the future to protect young children against Polio serotype 2. Disease with Polio type 2 indeed recently re-appeared, so vaccination of young children to come to a complete eradication of Polio is needed. The standard use of Imovax to protect against Polio serotype 2 would be too expensive. Therefore, a monovalent Polio vaccine containing only serotype 2 (= the vaccine that will be evaluated in this study), has been developed.

The duration of the study will be approximately 6 months. 120 subjects between 18 and 45 years of age will participate in Belgium.

During the study there will be 2 groups of subjects. Subjects will be assigned by chance to one of these groups. One group will receive one single injection of the study vaccine m-IPV2 HD (which contains only serotype 2), the other group will receive one single injection of the standard polio vaccine IPV, Imovax (which contains the 3 serotypes).

After this vaccination, there will be a follow-up period of 6 months. Subjects will be asked to come to the study centre one more time for the second visit (on Day 8, which is 7 days after the first visit). They will also receive 2 follow-up phone calls for approximately one month and 6 months after vaccination.


Condition Intervention Phase
Poliomyelitis
Biological: a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD)
Biological: a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®).
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase 1 Study on the Safety and Reactogenicity of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) Given Intramuscularly Compared to Standard Trivalent Inactivated Poliovirus Vaccine (IPV) in Healthy Adults

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • the safety of a single dose of m-IPV2 HD and licensed trivalent IPV [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    To assess the safety of a single dose of m-IPV2 HD and licensed trivalent IPV in healthy adults based on the incidence of serious and severe adverse events (AEs) within 4 weeks of vaccine administration.

  • the reactogenicity of a single dose of m-IPV2 HD and licensed trivalent IPV [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the reactogenicity of a single dose of m-IPV2 HD and licensed trivalent IPV in healthy adults based on the incidence of solicited local and general AEs within 7 days of vaccine administration.


Secondary Outcome Measures:
  • the safety of a single dose of m-IPV2 HD and licensed trivalent IPV [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To assess the safety of a single dose of m-IPV2 HD and licensed trivalent IPV in healthy adults based on the incidence of serious AEs within 6 months of vaccine administration.


Estimated Enrollment: 120
Study Start Date: November 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: control vaccine: Imovax Polio® Biological: a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD)
a single dose m-IPV2 HD (study vaccine), 0,5ml
Experimental: investigational vaccine Biological: a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®).
a single 0.5 ml dose Imovax Polio (control vaccine)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults 18-45 years of age
  • Subjects born in Belgium or any other country where mandatory polio vaccination is performed.
  • Written informed consent obtained from the subject.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    1. has practiced adequate contraception for 30 days prior to vaccination, and
    2. has a negative pregnancy test on the day of vaccination, and
    3. has agreed to continue adequate contraception for 2 months after vaccination.

Exclusion Criteria:

  • Participation in another clinical trial.
  • Any polio vaccine within 6 months before study inclusion.
  • Any other vaccination in the period starting 14 days before administration of study vaccine and ending 28 days after administration of the study vaccine.
  • Previous severe reaction after vaccination with polio vaccine.
  • Known hypersensitivity to one or more components of the vaccine.
  • Uncontrolled, clinically significant neuro-psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease.
  • Subjects with an history of malignant disease (cancer)
  • Known human immunodeficiency virus (HIV) positivity or other immune deficiency or immune suppressive treatment or auto-immune disease. For corticosteroids, a prednisone dose of <20 mg/day, or equivalent, is allowed. Inhaled and topical corticosteroids are allowed.
  • Acute disease and/or fever (higher or equal to 37.5°C, measured orally) at the time of enrolment. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory tract infection) without fever may be enrolled at the discretion of the investigator.
  • Pregnant or lactating female. Subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is inappropriate for any other reason.
  • Known hypersensitivity to one or more components of the vaccine.
  • Uncontrolled, clinically significant neuro-psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease.
  • Subjects with an history of malignant disease (cancer)
  • Known human immunodeficiency virus (HIV) positivity or other immune deficiency or immune suppressive treatment or auto-immune disease. For corticosteroids, a prednisone dose of <20 mg/day, or equivalent, is allowed. Inhaled and topical corticosteroids are allowed.
  • Acute disease and/or fever (higher or equal to 37.5°C, measured orally) at the time of enrolment. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory tract infection) without fever may be enrolled at the discretion of the investigator.
  • Pregnant or lactating female.
  • Subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is inappropriate for any other reason.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997632

Contacts
Contact: Geert Leroux- Roels, MD, PhD +32 (0)93322068 geert.lerouxroels@ugent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Oost-Vlaanderen, Belgium, 9000
Contact: Geert Leroux-Roels, MD, PhD    +32 (0)9/332 20 68      
Contact: Fien De Boever    +32 (0)9/332 20 68      
Principal Investigator: Geert Leroux-Roels, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Geert Leroux-Roels, MD, PhD University Hospital, Ghent
  More Information

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01997632     History of Changes
Other Study ID Numbers: 2013/914, 2013-004598-29
Study First Received: November 22, 2013
Last Updated: November 27, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
Poliomyelitis
Vaccine

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

ClinicalTrials.gov processed this record on November 27, 2014