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

May 16, 2018 updated by: Univ. Prof. Dr. Ursula Wiedermann, Medical University of Vienna
FSME-Immun® is registered for application into the muscle. This study investigates if application under the skin leads to a comparable immune response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

116

Phase

  • Phase 4

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

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
before (day 0) and 1 week after booster vaccination
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)
before (day 0) and 1week, 1 month, 6 months after booster vaccination

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Ursula Wiedermann, MD, PhD, Medical University Vienna, ISPTM

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

October 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • RV_FSME_1.2

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.

Clinical Trials on Vaccine Efficacy

Clinical Trials on FSME-Immune vaccination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe