Vaccine Responsiveness in AllergyPhase 4NCT02511535

TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients

A Phase 4 study testing TBE booster vaccination in people with Vaccine Responsiveness in Allergy and Vaccine Responsiveness During Allergy De-sensitization Treatment, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Allergic patients especially those undergoing de-sensitization treatment have an altered immune responsiveness. The investigators aim to find out whether this influences immune responses to primary and booster vaccinations. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Vaccine Responsiveness in Allergy, Vaccine Responsiveness During Allergy De-sensitization Treatment
What is being tested?: TBE booster vaccination
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 1 siteAustria
Study dates: Sep 2013to Sep 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

age < 18 and > 60 years
prior TBE infection
Hepatitis A vaccination
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

Show all 15Show fewer

administration of other vaccines 4 weeks before/after TBE vaccination
planned surgery within 2 weeks before/after TBE vaccination
Start of de-sensitization and the first 4 weeks of allergen dose escalation
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

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine
Vienna, 1090

Other trials in Austria

About this study

Official title: TBE (Tick-borne Encephalitis ) Vaccination in Allergic Patients

Read the detailed description

Allergic patients generally have an altered immunologic profile (Th2 bias), and allergic individuals undergoing de-sensitization treatment display an increased production of immune suppressive cytokines. The investigators measure humoral and cellular immune responses to routine vaccination (Tick-borne Encephalitis [TBE] booster) in allergic patients with and without de-sensitization treatment to determine whether allergy negatively influences vaccine induced immune responses and protection.

Conditions: Vaccine Responsiveness in Allergy, Vaccine Responsiveness During Allergy De-sensitization Treatment
Being tested: TBE booster vaccination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TBE booster vaccinationBiological
Also called Vaccine: FSME-Immun® (Fruehsommer-Meningoencephalitis), One dose (0.5 ml) contains:, 2.4 micrograms Tick-Borne Encephalitis Virus ( strain Neudoerfl),, adsorbed on aluminium oxide, hydrated (0.35 milligrams Al3+)

Study groups in NCT02511535
Study group	Role	What they receive
Allergic patients	Experimental	Allergic patients receive TBE booster vaccination Receives: Biological: TBE booster vaccination
Allergic patients with de-sensitization treatment	Experimental	Allergic patients with de-sensitization treatment receive TBE booster vaccination Receives: Biological: TBE booster vaccination
Healthy controls	Active comparator	Healthy controls receive TBE booster vaccination Receives: Biological: TBE booster vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

Humoral TBE Immunity
Geometric mean titers of TBE specific neutralizing Abs
Measured: one month after booster vaccination

Secondary outcomes (3)

Cellular Immune Response - Cytokine Production
cytokine production of antigen-specifically re-stimulated PMBC, IL-2 (interleukin 2) IFN g (interferon gamma) IL-10 (interleukin 10) IL-5 (interleukin 5)
Measured: before (day 0) and 1week after booster vaccination
Cellular Immune Response - Lymphocyte Subpopulations
analyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes
Measured: before (day 0) and 1week after booster vaccination
TBE Titer Course
Fold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination
Measured: before (day 0) until 6 months after booster vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Sep 2016

First posted30 Jul 2015 (estimated)
Study startSep 2013
Primary completionFeb 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Vaccine Responsiveness in AllergyStudies of the same condition, open and under way.
More trials run by Medical University of ViennaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02511535
Sponsor's protocol ID: TBE_1.1
Status last verified: Oct 2019
First submitted: 23 Jul 2015
Last updated: 25 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Garner-Spitzer E, Seidl-Friedrich C, Zwazl I, Hofer M, Kinaciyan T, Jarisch R, Stiasny K, Zlabinger GJ, Kundi M, Wiedermann U. Allergic patients with and without allergen-specific immunotherapy mount protective immune responses to tick-borne encephalitis vaccination in absence of enhanced side effects or propagation of their Th2 bias. Vaccine. 2018 May 11;36(20):2816-2824. doi: 10.1016/j.vaccine.2018.03.076. Epub 2018 Apr 16.
PubMed 29673942

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TBE (Tick-borne Encephalitis ) Vaccination in Allergic Patients
ClinicalTrials.gov ID: NCT02511535
Acronym / sponsor ID: TBE_1.1
Conditions: Vaccine Responsiveness in Allergy, Vaccine Responsiveness During Allergy De-sensitization Treatment
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Medical University of ViennaUniversity, hospital or other
Study start: Sep 2013
Primary completion: Feb 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 30 Jul 2015 (estimated)
Results: Posted 25 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Allergic patients	Experimental	Biological: TBE booster vaccinationAllergic patients receive TBE booster vaccination
Allergic patients with de-sensitization treatment	Experimental	Biological: TBE booster vaccinationAllergic patients with de-sensitization treatment receive TBE booster vaccination
Healthy controls	Active comparator	Biological: TBE booster vaccinationHealthy controls receive TBE booster vaccination

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (15 listed)

age < 18 and > 60 years
prior TBE infection
Hepatitis A vaccination
pregnancy and breast feeding
acute infection on day of inclusion (day 0), body temperature >37,9°C

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TBE booster vaccinationAlso: Vaccine: FSME-Immun® (Fruehsommer-Meningoencephalitis), One dose (0.5 ml) contains:, 2.4 micrograms Tick-Borne Encephalitis Virus ( strain Neudoerfl),, adsorbed on aluminium oxide, hydrated (0.35 milligrams Al3+)	Biological	Allergic patients, Allergic patients with de-sensitization treatment, Healthy controls

Primary outcome

Humoral TBE Immunity
Time frame: one month after booster vaccination
Geometric mean titers of TBE specific neutralizing Abs

3 secondary outcomes

Cellular Immune Response - Cytokine Production
Time frame: before (day 0) and 1week after booster vaccination
Cellular Immune Response - Lymphocyte Subpopulations
Time frame: before (day 0) and 1week after booster vaccination
TBE Titer Course
Time frame: before (day 0) until 6 months after booster vaccination

Results and safety

Results posted to the registry on 25 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Allergic Patients	49	49
Allergic Patients With De-sensitization Treatment	21	21
Healthy Controls	49	49

Primary outcome: Humoral TBE Immunity

Time frame: one month after booster vaccination. Geometric mean (95% Confidence Interval). Unit: titer

Measure	Allergic Patients n = 49	Allergic Patients With De-sensitization Treatment n = 21	Healthy Controls n = 49
Value	317.90 (238.70 to 423.30)	250.10 (143.90 to 434.40)	282.20 (210.60 to 378.20)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Allergic Patients	0 of 49 (0%)	23 of 49 (46.9%)	0 of 49
Allergic Patients With De-sensitization Treatment	0 of 21 (0%)	12 of 21 (57.1%)	0 of 21
Healthy Controls	0 of 49 (0%)	27 of 49 (55.1%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29673942Garner-Spitzer E, Seidl-Friedrich C, Zwazl I, Hofer M, Kinaciyan T, Jarisch R, Stiasny K, Zlabinger GJ, Kundi M, Wiedermann U. Allergic patients with and without allergen-specific immunotherapy mount protective immune responses to tick-borne encephalitis vaccination in absence of enhanced side effects or propagation of their Th2 bias. Vaccine. 2018 May 11;36(20):2816-2824. doi: 10.1016/j.vaccine.2018.03.076. Epub 2018 Apr 16.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ursula Wiedermann, MD, PhD principal investigator

Medical University of Vienna

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Humoral TBE Immunity (time frame: one month after booster vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02511535, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.