Induction of Cross-neutralizing Antibodies After Primary Vaccination With Two Different Tick- borne Encephalitis Virus Vaccines

Phase 1

• Conditions: The study is exploring the cross neutralizing potential of human sera after primary immunization with FSME-IMMUN 0.5 ml or Encepur 0.5 ml against different strains within the same TBEV subtype, other TBEV subtypes, closely related viruses of the TBEV serogroup, and also more distantly related flaviviruses, based on the use of a hybrid virus assay platform; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-003124-23-AT
• Lead Sponsor: Medical University of Vienna, ISPTM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-10
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Male and female subjects will be eligible for participation in this study if they:
Are healthy adults, aged >18 – <50 years of age, who are naïve towards west-nile virus (WNV), yellow fever virus (YFV), Japanese encephalitis virus (JEV), Dengue viruses and TBE virus, i.e. who have never been either vaccinated against the above mentioned viral infections nor have had any of the mentioned diseases in their medical history.
Confirm willingness to comply with the study protocol by signing the Informed Consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will not be eligible to participate in this study if any of the following apply:
Age < 18 or > 50 years
History of vaccination against WNV, YFV, JE, Dengue or TBE
History of a WNV, YFV, JE, Dengue or TBE infection
Contraindication against vaccination with a tick-borne encephalitis vaccine, according to the respective SmPC
Pregnancy or breast feeding
Medication treatment influencing the immune system: e.g. systemic corticoids (> 20mg/d), immunotherapy (e.g. allergy), chemotherapy, immunosuppressive drugs within 4 weeks of study start or during the study
Other vaccinations within 4 weeks of study start till 4 weeks after the second vaccination and 4 weeks before till 4 weeks after the third vaccination
Any surgery, requiring hospitalization, within 4 weeks of study start and/or planned surgery during the study
Severe medical condition requiring hospitalization within 3 months of study start
Any current malignancy within 5 years of study start
Autoimmune disease²
Progressive, unstable or uncontrolled clinical conditions
Abuse disorder (abuse of drug, alcohol, chemical or psychoactive substance) or mental disability
Receipt of plasma, blood or blood products, as well as immunoglobulins within 3 months of study start and during the study
Plasma, blood and blood product donation within 3 months of study start and during the study
Concomitant participation in another clinical trial
Employee of the study center with direct study involvement or family member of the Investigator or employee with direct study involvement

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified