Trial Outcomes & Findings for Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun® (NCT NCT02511587)
NCT ID: NCT02511587
Last Updated: 2018-05-18
Results Overview
GMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
116 participants
Primary outcome timeframe
1 month
Results posted on
2018-05-18
Participant Flow
Participant milestones
| Measure |
Intra Muscular Application
intra muscular application of FSME-Immune vaccination
FSME-Immune vaccination: booster vaccination with FSME-Immune
|
Subcutaneous Application
subcutaneous application of FSME-Immune vaccination
FSME-Immune vaccination: booster vaccination with FSME-Immune
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
|
Overall Study
COMPLETED
|
58
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®
Baseline characteristics by cohort
| Measure |
Intra Muscular Application
n=58 Participants
intra muscular application of FSME-Immune vaccination
FSME-Immune vaccination: booster vaccination with FSME-Immune
|
Subcutaneous Application
n=58 Participants
subcutaneous application of FSME-Immune vaccination
FSME-Immune vaccination: booster vaccination with FSME-Immune
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthGMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination
Outcome measures
| Measure |
Intra Muscular Application
n=58 Participants
intra muscular application of FSME-Immune vaccination
FSME-Immune vaccination: booster vaccination with FSME-Immune
|
Subcutaneous Application
n=58 Participants
subcutaneous application of FSME-Immune vaccination
FSME-Immune vaccination: booster vaccination with FSME-Immune
|
|---|---|---|
|
Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine
|
574.8 Geometric mean titers
Interval 439.0 to 751.0
|
612.0 Geometric mean titers
Interval 483.0 to 775.0
|
SECONDARY outcome
Timeframe: before (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)
Outcome measures
| Measure |
Intra Muscular Application
n=58 Participants
intra muscular application of FSME-Immune vaccination
FSME-Immune vaccination: booster vaccination with FSME-Immune
|
Subcutaneous Application
n=58 Participants
subcutaneous application of FSME-Immune vaccination
FSME-Immune vaccination: booster vaccination with FSME-Immune
|
|---|---|---|
|
Cellular Immune Responses - Cytokines
IFNg before vaccination
|
2376 pg/ml
Standard Deviation 2099
|
2199 pg/ml
Standard Deviation 1781
|
|
Cellular Immune Responses - Cytokines
IFNg one week post vacc
|
3071 pg/ml
Standard Deviation 2347
|
3387 pg/ml
Standard Deviation 4375
|
|
Cellular Immune Responses - Cytokines
IL-2 before vaccination
|
81.8 pg/ml
Standard Deviation 111.4
|
57.6 pg/ml
Standard Deviation 66.1
|
|
Cellular Immune Responses - Cytokines
IL-2 one week post vacc
|
77.0 pg/ml
Standard Deviation 97.8
|
56.5 pg/ml
Standard Deviation 54.0
|
|
Cellular Immune Responses - Cytokines
IL-10 before vaccination
|
183.5 pg/ml
Standard Deviation 219.8
|
192.8 pg/ml
Standard Deviation 307.7
|
|
Cellular Immune Responses - Cytokines
IL-10 one week post vacc
|
210.6 pg/ml
Standard Deviation 210.3
|
297.4 pg/ml
Standard Deviation 343.3
|
SECONDARY outcome
Timeframe: before (day 0) and 1week, 1 month, 6 months after booster vaccinationTBE specific neutralizing antibody titer profiles (geometric mean titers, GMT)
Outcome measures
| Measure |
Intra Muscular Application
n=58 Participants
intra muscular application of FSME-Immune vaccination
FSME-Immune vaccination: booster vaccination with FSME-Immune
|
Subcutaneous Application
n=58 Participants
subcutaneous application of FSME-Immune vaccination
FSME-Immune vaccination: booster vaccination with FSME-Immune
|
|---|---|---|
|
TBE Titer Profile
GMT at d0
|
249.9 Geometric mean titers
Interval 185.3 to 337.1
|
208.8 Geometric mean titers
Interval 159.2 to 273.8
|
|
TBE Titer Profile
GMT after 1 week
|
360.9 Geometric mean titers
Interval 278.8 to 467.2
|
317.2 Geometric mean titers
Interval 245.1 to 410.6
|
|
TBE Titer Profile
GMT after one month
|
574.8 Geometric mean titers
Interval 439.5 to 751.6
|
612.0 Geometric mean titers
Interval 483.0 to 775.4
|
|
TBE Titer Profile
GMT after 6 month
|
420.1 Geometric mean titers
Interval 318.5 to 554.2
|
380.5 Geometric mean titers
Interval 293.5 to 493.5
|
Adverse Events
Intra Muscular Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subcutaneous Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Univ.-Prof. Dr. Ursula Wiedermann
Medical University of Vienna
Phone: 0043 1 40160 38291
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place