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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02511587
Enrollment
116
Registered
2015-07-30
Start date
2012-10-31
Completion date
2015-06-30
Last updated
2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccine Efficacy

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.

Interventions

BIOLOGICALFSME-Immune vaccination

booster vaccination with FSME-Immune

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine1 monthGMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination

Secondary

MeasureTime frameDescription
Cellular Immune Responses - Cytokinesbefore (day 0) and 1 week after booster vaccinationcytokine production of antigen-specifically restimulated PMBC (peripheral blood mononuclear cells) is evaluated (Interleukin 2, Interleukin 10, Interferon gamma)
TBE Titer Profilebefore (day 0) and 1week, 1 month, 6 months after booster vaccinationTBE specific neutralizing antibody titer profiles (geometric mean titers, GMT)

Participant flow

Participants by arm

ArmCount
Intra Muscular Application
intra muscular application of FSME-Immune vaccination FSME-Immune vaccination: booster vaccination with FSME-Immune
58
Subcutaneous Application
subcutaneous application of FSME-Immune vaccination FSME-Immune vaccination: booster vaccination with FSME-Immune
58
Total116

Baseline characteristics

CharacteristicIntra Muscular ApplicationSubcutaneous ApplicationTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
58 Participants58 Participants116 Participants
Sex: Female, Male
Female
29 Participants29 Participants58 Participants
Sex: Female, Male
Male
29 Participants29 Participants58 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 580 / 58
serious
Total, serious adverse events
0 / 580 / 58

Outcome results

Primary

Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine

GMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination

Time frame: 1 month

ArmMeasureValue (GEOMETRIC_MEAN)
Intra Muscular ApplicationHumoral Immunity to TBE (Tick-borne Encephalitis) Vaccine574.8 Geometric mean titers
Subcutaneous ApplicationHumoral Immunity to TBE (Tick-borne Encephalitis) Vaccine612.0 Geometric mean titers
Secondary

Cellular Immune Responses - Cytokines

cytokine production of antigen-specifically restimulated PMBC (peripheral blood mononuclear cells) is evaluated (Interleukin 2, Interleukin 10, Interferon gamma)

Time frame: before (day 0) and 1 week after booster vaccination

ArmMeasureGroupValue (MEAN)Dispersion
Intra Muscular ApplicationCellular Immune Responses - CytokinesIL-2 before vaccination81.8 pg/mlStandard Deviation 111.4
Intra Muscular ApplicationCellular Immune Responses - CytokinesIFNg before vaccination2376 pg/mlStandard Deviation 2099
Intra Muscular ApplicationCellular Immune Responses - CytokinesIFNg one week post vacc3071 pg/mlStandard Deviation 2347
Intra Muscular ApplicationCellular Immune Responses - CytokinesIL-2 one week post vacc77.0 pg/mlStandard Deviation 97.8
Intra Muscular ApplicationCellular Immune Responses - CytokinesIL-10 before vaccination183.5 pg/mlStandard Deviation 219.8
Intra Muscular ApplicationCellular Immune Responses - CytokinesIL-10 one week post vacc210.6 pg/mlStandard Deviation 210.3
Subcutaneous ApplicationCellular Immune Responses - CytokinesIL-10 before vaccination192.8 pg/mlStandard Deviation 307.7
Subcutaneous ApplicationCellular Immune Responses - CytokinesIL-2 one week post vacc56.5 pg/mlStandard Deviation 54
Subcutaneous ApplicationCellular Immune Responses - CytokinesIFNg before vaccination2199 pg/mlStandard Deviation 1781
Subcutaneous ApplicationCellular Immune Responses - CytokinesIL-10 one week post vacc297.4 pg/mlStandard Deviation 343.3
Subcutaneous ApplicationCellular Immune Responses - CytokinesIFNg one week post vacc3387 pg/mlStandard Deviation 4375
Subcutaneous ApplicationCellular Immune Responses - CytokinesIL-2 before vaccination57.6 pg/mlStandard Deviation 66.1
Secondary

TBE Titer Profile

TBE specific neutralizing antibody titer profiles (geometric mean titers, GMT)

Time frame: before (day 0) and 1week, 1 month, 6 months after booster vaccination

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Intra Muscular ApplicationTBE Titer ProfileGMT at d0249.9 Geometric mean titers
Intra Muscular ApplicationTBE Titer ProfileGMT after 1 week360.9 Geometric mean titers
Intra Muscular ApplicationTBE Titer ProfileGMT after one month574.8 Geometric mean titers
Intra Muscular ApplicationTBE Titer ProfileGMT after 6 month420.1 Geometric mean titers
Subcutaneous ApplicationTBE Titer ProfileGMT after 6 month380.5 Geometric mean titers
Subcutaneous ApplicationTBE Titer ProfileGMT at d0208.8 Geometric mean titers
Subcutaneous ApplicationTBE Titer ProfileGMT after one month612.0 Geometric mean titers
Subcutaneous ApplicationTBE Titer ProfileGMT after 1 week317.2 Geometric mean titers

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026