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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

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.

Condition or disease Intervention/treatment Phase
Vaccine Efficacy Biological: FSME-Immune vaccination Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®
Study Start Date : October 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Active Comparator: intra muscular application
intra muscular application of FSME-Immune vaccination
Biological: FSME-Immune vaccination
booster vaccination with FSME-Immune

Experimental: subcutaneous application
subcutaneous application of FSME-Immune vaccination
Biological: FSME-Immune vaccination
booster vaccination with FSME-Immune




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511587


Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Ursula Wiedermann, MD, PhD Medical University Vienna, ISPTM

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Responsible Party: Univ. Prof. Dr. Ursula Wiedermann, Univ.-Prof. Dr. Ursula Wiedermann, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02511587     History of Changes
Other Study ID Numbers: RV_FSME_1.2
First Posted: July 30, 2015    Key Record Dates
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs