Trial Outcomes & Findings for TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients (NCT NCT02511535)
NCT ID: NCT02511535
Last Updated: 2019-10-25
Results Overview
Geometric mean titers of TBE specific neutralizing Abs
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
119 participants
Primary outcome timeframe
one month after booster vaccination
Results posted on
2019-10-25
Participant Flow
Participant milestones
| Measure |
Allergic Patients
Allergic patients receive TBE booster vaccination
TBE booster vaccination
|
Allergic Patients With De-sensitization Treatment
Allergic patients with de-sensitization treatment receive TBE booster vaccination
TBE booster vaccination
|
Healthy Controls
Healthy controls receive TBE booster vaccination
TBE booster vaccination
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
21
|
49
|
|
Overall Study
COMPLETED
|
49
|
21
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients
Baseline characteristics by cohort
| Measure |
Allergic Patients
n=49 Participants
Allergic patients receive TBE booster vaccination
|
Allergic Patients With De-sensitization Treatment
n=21 Participants
Allergic patients with de-sensitization treatment receive TBE booster vaccination
|
Healthy Controls
n=49 Participants
Healthy controls receive TBE booster vaccination
|
Total
n=119 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
49 participants
n=5 Participants
|
21 participants
n=7 Participants
|
49 participants
n=5 Participants
|
119 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: one month after booster vaccinationGeometric mean titers of TBE specific neutralizing Abs
Outcome measures
| Measure |
Allergic Patients
n=49 Participants
Allergic patients receive TBE booster vaccination
|
Allergic Patients With De-sensitization Treatment
n=21 Participants
Allergic patients with de-sensitization treatment receive TBE booster vaccination
|
Healthy Controls
n=49 Participants
Healthy controls receive TBE booster vaccination
|
|---|---|---|---|
|
Humoral TBE Immunity
|
317.90 titer
Interval 238.7 to 423.3
|
250.10 titer
Interval 143.9 to 434.4
|
282.20 titer
Interval 210.6 to 378.2
|
SECONDARY outcome
Timeframe: before (day 0) and 1week after booster vaccinationPopulation: the missing cytokine concentrations were not used for calculation because of invalid positive controls (due to poor PBMC \[peripheral blood mononuclear cell\] viability)
cytokine production of antigen-specifically re-stimulated PMBC, IL-2 (interleukin 2) IFN g (interferon gamma) IL-10 (interleukin 10) IL-5 (interleukin 5)
Outcome measures
| Measure |
Allergic Patients
n=49 Participants
Allergic patients receive TBE booster vaccination
|
Allergic Patients With De-sensitization Treatment
n=21 Participants
Allergic patients with de-sensitization treatment receive TBE booster vaccination
|
Healthy Controls
n=49 Participants
Healthy controls receive TBE booster vaccination
|
|---|---|---|---|
|
Cellular Immune Response - Cytokine Production
IL-2 one week post vacc
|
53.80 pg/ml
Interval 37.03 to 78.18
|
37.11 pg/ml
Interval 24.44 to 56.34
|
51.07 pg/ml
Interval 34.57 to 75.44
|
|
Cellular Immune Response - Cytokine Production
IL-5 before vaccination
|
2.08 pg/ml
Interval 1.81 to 2.4
|
1.85 pg/ml
Interval 1.85 to 1.85
|
2.04 pg/ml
Interval 1.87 to 2.23
|
|
Cellular Immune Response - Cytokine Production
IL-5 one week post vaccination
|
2.96 pg/ml
Interval 2.32 to 3.77
|
1.87 pg/ml
Interval 1.84 to 1.9
|
2.85 pg/ml
Interval 2.23 to 3.64
|
|
Cellular Immune Response - Cytokine Production
IFNg before vaccination
|
37.85 pg/ml
Interval 25.86 to 55.39
|
42.54 pg/ml
Interval 23.36 to 77.49
|
38.91 pg/ml
Interval 25.13 to 59.01
|
|
Cellular Immune Response - Cytokine Production
IFNg 1 week post vacc
|
54.19 pg/ml
Interval 37.61 to 78.08
|
59.45 pg/ml
Interval 32.67 to 108.17
|
77.27 pg/ml
Interval 52.26 to 114.25
|
|
Cellular Immune Response - Cytokine Production
IL-10 before vaccination
|
35.21 pg/ml
Interval 25.9 to 47.86
|
38.86 pg/ml
Interval 23.75 to 63.58
|
30.28 pg/ml
Interval 21.15 to 43.37
|
|
Cellular Immune Response - Cytokine Production
IL-10 one week post vacc
|
48.90 pg/ml
Interval 36.6 to 65.33
|
52.13 pg/ml
Interval 37.0 to 73.44
|
52.28 pg/ml
Interval 36.47 to 74.95
|
|
Cellular Immune Response - Cytokine Production
IL-2 before vaccination
|
52.62 pg/ml
Interval 36.54 to 75.78
|
35.41 pg/ml
Interval 21.25 to 59.02
|
37.20 pg/ml
Interval 24.43 to 56.64
|
SECONDARY outcome
Timeframe: before (day 0) and 1week after booster vaccinationanalyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes
Outcome measures
| Measure |
Allergic Patients
n=49 Participants
Allergic patients receive TBE booster vaccination
|
Allergic Patients With De-sensitization Treatment
n=21 Participants
Allergic patients with de-sensitization treatment receive TBE booster vaccination
|
Healthy Controls
n=49 Participants
Healthy controls receive TBE booster vaccination
|
|---|---|---|---|
|
Cellular Immune Response - Lymphocyte Subpopulations
B cells (CD19 +) at day 0
|
7.63 percent of total lymphocytes
Interval 6.67 to 8.57
|
7.01 percent of total lymphocytes
Interval 6.04 to 7.98
|
7.11 percent of total lymphocytes
Interval 6.34 to 7.89
|
|
Cellular Immune Response - Lymphocyte Subpopulations
B cells (CD19 +) 1 week after booster vaccination
|
7.22 percent of total lymphocytes
Interval 6.33 to 8.11
|
6.34 percent of total lymphocytes
Interval 5.34 to 7.34
|
6.39 percent of total lymphocytes
Interval 5.78 to 7.01
|
|
Cellular Immune Response - Lymphocyte Subpopulations
T cells (CD3 +) at day 0
|
69.3 percent of total lymphocytes
Interval 66.9 to 71.8
|
73.7 percent of total lymphocytes
Interval 70.9 to 76.5
|
68.2 percent of total lymphocytes
Interval 65.5 to 71.0
|
|
Cellular Immune Response - Lymphocyte Subpopulations
T cells (CD3 +) 1 week after booster vaccination
|
68.7 percent of total lymphocytes
Interval 66.1 to 71.2
|
74.7 percent of total lymphocytes
Interval 72.4 to 77.1
|
70.6 percent of total lymphocytes
Interval 68.3 to 72.9
|
|
Cellular Immune Response - Lymphocyte Subpopulations
T helper cells (CD4 +) at day 0
|
42.3 percent of total lymphocytes
Interval 39.9 to 44.6
|
49.1 percent of total lymphocytes
Interval 45.5 to 52.4
|
41.6 percent of total lymphocytes
Interval 38.7 to 44.4
|
|
Cellular Immune Response - Lymphocyte Subpopulations
T helper cells (CD4 +) 1 week after booster
|
42.7 percent of total lymphocytes
Interval 40.4 to 45.0
|
50.5 percent of total lymphocytes
Interval 47.6 to 53.4
|
43.0 percent of total lymphocytes
Interval 40.1 to 45.8
|
|
Cellular Immune Response - Lymphocyte Subpopulations
cytotoxic T cells (CD8 +) at day 0
|
21.5 percent of total lymphocytes
Interval 19.8 to 23.3
|
20.3 percent of total lymphocytes
Interval 17.0 to 23.4
|
20.6 percent of total lymphocytes
Interval 18.4 to 22.8
|
|
Cellular Immune Response - Lymphocyte Subpopulations
cytotoxic T cells (CD8 +) 1 week after booster
|
20.9 percent of total lymphocytes
Interval 19.3 to 22.6
|
20.7 percent of total lymphocytes
Interval 17.5 to 23.8
|
21.2 percent of total lymphocytes
Interval 19.0 to 23.3
|
|
Cellular Immune Response - Lymphocyte Subpopulations
Tregs (CD4+ FOXP3+) at day 0
|
4.65 percent of total lymphocytes
Interval 4.2 to 5.13
|
5.36 percent of total lymphocytes
Interval 4.61 to 6.16
|
4.49 percent of total lymphocytes
Interval 4.1 to 4.89
|
|
Cellular Immune Response - Lymphocyte Subpopulations
Tregs (CD4+ FOXP3+) 1 week after booster
|
4.54 percent of total lymphocytes
Interval 4.1 to 5.01
|
5.60 percent of total lymphocytes
Interval 4.93 to 6.3
|
4.21 percent of total lymphocytes
Interval 3.84 to 4.6
|
SECONDARY outcome
Timeframe: before (day 0) until 6 months after booster vaccinationFold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination
Outcome measures
| Measure |
Allergic Patients
n=49 Participants
Allergic patients receive TBE booster vaccination
|
Allergic Patients With De-sensitization Treatment
n=21 Participants
Allergic patients with de-sensitization treatment receive TBE booster vaccination
|
Healthy Controls
n=49 Participants
Healthy controls receive TBE booster vaccination
|
|---|---|---|---|
|
TBE Titer Course
fold change 6 month after booster
|
1.95 fold change from d0 (before booster)
Interval 1.54 to 2.46
|
2.53 fold change from d0 (before booster)
Interval 1.81 to 3.54
|
1.79 fold change from d0 (before booster)
Interval 1.41 to 2.29
|
|
TBE Titer Course
fold change 1 week after booster
|
1.46 fold change from d0 (before booster)
Interval 1.23 to 1.73
|
1.80 fold change from d0 (before booster)
Interval 1.36 to 2.37
|
1.79 fold change from d0 (before booster)
Interval 1.5 to 2.14
|
|
TBE Titer Course
fold change 4 weeks after booster
|
3.02 fold change from d0 (before booster)
Interval 2.43 to 3.77
|
3.01 fold change from d0 (before booster)
Interval 2.05 to 4.41
|
2.56 fold change from d0 (before booster)
Interval 2.09 to 3.13
|
Adverse Events
Allergic Patients
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Allergic Patients With De-sensitization Treatment
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Allergic Patients
n=49 participants at risk
Allergic patients receive TBE booster vaccination
|
Allergic Patients With De-sensitization Treatment
n=21 participants at risk
Allergic patients with de-sensitization treatment receive TBE booster vaccination
|
Healthy Controls
n=49 participants at risk
Healthy controls receive TBE booster vaccination
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
vaccine reactogenicity
|
46.9%
23/49
|
57.1%
12/21
|
55.1%
27/49
|
Additional Information
Erika Garner-Spitzer, PhD
Med Uni Wien, Institut für Spezifische Prophylaxe und Tropenmedizin
Phone: 0043 1 40160
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place