Trial Outcomes & Findings for Vaccine Study for Tick-Borne Encephalitis Virus (TBEV) (NCT NCT01031537)
NCT ID: NCT01031537
Last Updated: 2018-07-05
Results Overview
Tick borne encephalitis antibody viral neutralization titer levels (\>1:10)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Baseline
Results posted on
2018-07-05
Participant Flow
2 subjects withdrew after the screening visit and elected not re-enroll. 1 subject was a study screen failure.
Participant milestones
| Measure |
FSME-IMMUN 0.5mL Baxter
FSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis. The FSME-IMMUN 0.5mL Baxter is available as 0.5mL in a pre-loaded vaccine syringe. All participants will receive active vaccine using a rapid immunization schedule, with vaccine administration on Days 0, 14, 161 and 245. Participants that test seropositive for tick-borne encephalitis or subjects that develop positive viral neutralizer titers after the 3rd or 4th vaccine will be given a booster of FSME-IMMUN 0.5mL Baxter vaccine at 3, 6 and 9 years after enrollment.
FSME-IMMUN 0.5ml Baxter: Vaccine
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
FSME-IMMUN 0.5mL Baxter
FSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis. The FSME-IMMUN 0.5mL Baxter is available as 0.5mL in a pre-loaded vaccine syringe. All participants will receive active vaccine using a rapid immunization schedule, with vaccine administration on Days 0, 14, 161 and 245. Participants that test seropositive for tick-borne encephalitis or subjects that develop positive viral neutralizer titers after the 3rd or 4th vaccine will be given a booster of FSME-IMMUN 0.5mL Baxter vaccine at 3, 6 and 9 years after enrollment.
FSME-IMMUN 0.5ml Baxter: Vaccine
|
|---|---|
|
Overall Study
medical reasons not related to study
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
retired from NIH, met exclusion criteria
|
1
|
|
Overall Study
moved, met exclusion criteria
|
10
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
PI removal, no longer met eligibility
|
12
|
Baseline Characteristics
Vaccine Study for Tick-Borne Encephalitis Virus (TBEV)
Baseline characteristics by cohort
| Measure |
FSME-IMMUN 0.5mL Baxter
n=66 Participants
FSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis. The FSME-IMMUN 0.5mL Baxter is available as 0.5mL in a pre-loaded vaccine syringe. All participants received active vaccine using a rapid immunization schedule, with vaccine administration on Days 0, 14, 161 and 245. Participants that tested seropositive for tick-borne encephalitis or subjects that developed positive viral neutralizer titers after the 3rd or 4th vaccine were given a booster of FSME-IMMUN 0.5mL Baxter vaccine at 3, 6 and 9 years after enrollment.
FSME-IMMUN 0.5ml Baxter: Vaccine
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 Participants
n=5 Participants
|
|
Tick-Borne Encephalitis Virus Antibody Neutralization Titer
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Baseline TBEV protective antibody levels (\>1:10) reflective of either prior successful immunization or infection at baseline
Tick borne encephalitis antibody viral neutralization titer levels (\>1:10)
Outcome measures
| Measure |
FSME-IMMUN 0.5mL Baxter
n=66 Participants
FSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis. The FSME-IMMUN 0.5mL Baxter is available as 0.5mL in a pre-loaded vaccine syringe. All participants received active vaccine using a rapid immunization schedule, with vaccine administration on Days 0, 14, 161 and 245. Participants that tested seropositive for tick-borne encephalitis or subjects that developed positive viral neutralizer titers after the 3rd or 4th vaccine were given a booster of FSME-IMMUN 0.5mL Baxter vaccine at 3, 6 and 9 years after enrollment.
FSME-IMMUN 0.5ml Baxter: Vaccine
|
|---|---|
|
TBEV Viral Neutralization Titer >1:10
|
6 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Six participants had protective antibody levels (\>1:10) reflective of either prior successful immunization or infection at baseline and were not evaluated at the 6 month time point. One participant withdrew from the study prior to the 6 month evaluation time point.
The number of participants that develop anti-tick borne encephalitis antibody viral neutralization titer levels (\>1:10) following receipt of 3 doses of intramuscular FSME-IMMUN (vaccine series)
Outcome measures
| Measure |
FSME-IMMUN 0.5mL Baxter
n=59 Participants
FSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis. The FSME-IMMUN 0.5mL Baxter is available as 0.5mL in a pre-loaded vaccine syringe. All participants received active vaccine using a rapid immunization schedule, with vaccine administration on Days 0, 14, 161 and 245. Participants that tested seropositive for tick-borne encephalitis or subjects that developed positive viral neutralizer titers after the 3rd or 4th vaccine were given a booster of FSME-IMMUN 0.5mL Baxter vaccine at 3, 6 and 9 years after enrollment.
FSME-IMMUN 0.5ml Baxter: Vaccine
|
|---|---|
|
TBEV Viral Neutralization Titer >1:10
|
58 Participants
|
Adverse Events
FSME-IMMUN 0.5mL Baxter
Serious events: 10 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FSME-IMMUN 0.5mL Baxter
n=66 participants at risk
FSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis. The FSME-IMMUN 0.5mL Baxter is available as 0.5mL in a pre-loaded vaccine syringe. All participants will receive active vaccine using a rapid immunization schedule, with vaccine administration on Days 0, 14, 161 and 245. Participants that test seropositive for tick-borne encephalitis or subjects that develop positive viral neutralizer titers after the 3rd or 4th vaccine will be given a booster of FSME-IMMUN 0.5mL Baxter vaccine at 3, 6 and 9 years after enrollment.
FSME-IMMUN 0.5ml Baxter: Vaccine
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Infections and infestations
Urinary tract infection, relapsing fever
|
3.0%
2/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Injury, poisoning and procedural complications
Bladder laceration
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Stage IV lung cancer
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine fibroid
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast carcinoma
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
Other adverse events
| Measure |
FSME-IMMUN 0.5mL Baxter
n=66 participants at risk
FSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis. The FSME-IMMUN 0.5mL Baxter is available as 0.5mL in a pre-loaded vaccine syringe. All participants will receive active vaccine using a rapid immunization schedule, with vaccine administration on Days 0, 14, 161 and 245. Participants that test seropositive for tick-borne encephalitis or subjects that develop positive viral neutralizer titers after the 3rd or 4th vaccine will be given a booster of FSME-IMMUN 0.5mL Baxter vaccine at 3, 6 and 9 years after enrollment.
FSME-IMMUN 0.5ml Baxter: Vaccine
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain at the injection site
|
97.0%
64/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Nervous system disorders
Headache
|
37.9%
25/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.3%
18/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
General disorders
Fatigue
|
28.8%
19/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
7/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Skin and subcutaneous tissue disorders
Swelling
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Skin and subcutaneous tissue disorders
Itching
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
General disorders
Malaise
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
General disorders
Chills
|
1.5%
1/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.0%
2/66 • Adverse event data were collected from baseline (day 0), and on days 7, 14, 21, 35, 161, 168, 182, 245, 252, and 266, 3 years, and up to 6 years after vaccination. Note study was prematurely closed on July 5, 2016 as the manufacturer elected to stop providing the vaccine support for this study.
|
Additional Information
Dr. James M. Schmitt
Division of Occupational Health and Safety, NIH
Phone: 301-496-4411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place