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Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®

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ClinicalTrials.gov Identifier: NCT02511587
Recruitment Status : Completed
First Posted : July 30, 2015
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Univ. Prof. Dr. Ursula Wiedermann, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE July 23, 2015
First Posted Date  ICMJE July 30, 2015
Results First Submitted Date  ICMJE March 27, 2018
Results First Posted Date  ICMJE May 18, 2018
Last Update Posted Date May 18, 2018
Study Start Date  ICMJE October 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine [ Time Frame: 1 month ]
GMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2015)
Humoral immunity to TBE vaccine [ Time Frame: 1 month ]
GMT of TBE Neutralisation test titers one month after booster vaccination
Change History Complete list of historical versions of study NCT02511587 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
  • Cellular Immune Responses - Cytokines [ Time Frame: before (day 0) and 1 week after booster vaccination ]
    cytokine production of antigen-specifically restimulated PMBC (peripheral blood mononuclear cells) is evaluated (Interleukin 2, Interleukin 10, Interferon gamma)
  • TBE Titer Profile [ Time Frame: before (day 0) and 1week, 1 month, 6 months after booster vaccination ]
    TBE specific neutralizing antibody titer profiles (geometric mean titers, GMT)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2015)
  • Cellular Immune Responses - Cytokines [ Time Frame: before (day 0) and 1 week after booster vaccination ]
    cytokine production of antigen-specifically restimulated PMBC is evaluated (Interleukin 2, Interleukin 10, Interferon gamma)
  • TBE Titer Profile [ Time Frame: before (day 0) and 1week, 1 month, 6 months after booster vaccination ]
    TBE specific neutralizing Ab titer profiles (GMT)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®
Official Title  ICMJE Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®
Brief Summary FSME-Immun® is registered for application into the muscle. This study investigates if application under the skin leads to a comparable immune response.
Detailed Description Tick-borne encephalitis (TBE) vaccine (FSME-Immun®) is registered for intra-muscular application. Due to medical reasons (e.g. anticoagulant therapy, adipositas) intra-muscular application is not always possible. The aim of this clinical trial is to investigate whether a comparably good immunogenicity can be achieved via the subcutaneous vaccination route. Thus humoral and cellular immune responses after intramuscular and subcutaneous TBE vaccination in healthy volunteers will be compared.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Vaccine Efficacy
Intervention  ICMJE Biological: FSME-Immune vaccination
booster vaccination with FSME-Immune
Study Arms  ICMJE
  • Active Comparator: intra muscular application
    intra muscular application of FSME-Immune vaccination
    Intervention: Biological: FSME-Immune vaccination
  • Experimental: subcutaneous application
    subcutaneous application of FSME-Immune vaccination
    Intervention: Biological: FSME-Immune vaccination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2015)
116
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • completed primary TBE immunization + at least one booster immunization
  • adults of both sexes between 18 and 60 years of age
  • willingness to sign written informed consent form

Exclusion Criteria:

  • age < 18 and > 60 years
  • prior TBE infection
  • pregnancy and breast feeding
  • acute infection on day of inclusion (day 0), (body temperature > 37,9°C)
  • concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study
  • administration of other vaccines 4 weeks before/after day 0
  • planned surgery within 2 weeks before/after TBE booster vaccination
  • specific immunotherapy (Hypo-/Desensibilisation) 14 days before/after vaccination
  • any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions
  • history of malignant disease within the last 5 years
  • autoimmune diseases
  • drug addictions
  • plasma donors
  • receipt of blood transfusions or immuno globulins within 3 month before study entry
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02511587
Other Study ID Numbers  ICMJE RV_FSME_1.2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Univ. Prof. Dr. Ursula Wiedermann, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ursula Wiedermann, MD, PhD Medical University Vienna, ISPTM
PRS Account Medical University of Vienna
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP