Tick-Borne EncephalitisPhase 2TBEVNCT01031537
Vaccine Study for Tick-Borne Encephalitis Virus (TBEV)
A Phase 2 study testing FSME-IMMUN 0.5ml Baxter in people with Tick-Borne Encephalitis and Encephalitis, Tick-Borne, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
This was an open label trial of a non-US licensed vaccine for tick-borne encephalitis. The vaccine was licensed by Baxter, and now following an acquisition by Pfizer Inc in Vienna, Austria since 2001, and has an extensive safety record in multiple European countries. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Tick-Borne Encephalitis, Encephalitis, Tick-Borne, Tick-Borne Disease
- What is being tested?
- FSME-IMMUN 0.5ml Baxter
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Sep 2009to 23 Dec 2016
- Phase
- Phase 2
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects must meet the following criteria at study entry:
- Be engaged in activities that place them at potential risk of occupational exposure to TBEV in its viable form at one of the participating intramural laboratories of NIAID
- Be 18 years of age or older at the time of the first immunization.
- Comprehend the study requirements.
- Provide written informed consent to participate in this study.
- Be in good health as determined by the Investigator, based upon medical history and a targeted physical examination.
Show all 9Show fewer
- Have a stable health status as determined by the Investigator.
- Have access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common use phone serving multiple rooms or apartments).
- Express availability for the required study period, and ability to attend scheduled visits.
Who cannot join
- The following criteria should be checked at the time of the study entry. If any apply, the subject will not be included in the study:
- The subject must not be participating in any other trial of an investigational drug or vaccine for 1 month prior to the first injection through until 21 days after the third injection. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case by case basis after discussion between the Investigator and the IRB.)
- The presence on the day of immunization of an oral temperature of >101.2 degrees F or acute symptoms other than mild severity.
- Active systemic infectious process as determined by review of systems and physical examination. The subject may be enrolled at a later date once the illness has resolved.
- Known immune suppression, such as that associated with human immunodeficiency virus infection, or other condition, to the extent that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine. This information will be obtained by history only. Serologic screening for these diseases will not be performed.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the Investigator to render the potential subject unable/unlikely to report promptly any adverse reactions to the vaccine.
Show all 26Show fewer
- Current diagnosis of leukemia, Hodgkin s disease, non-Hodgkin s lymphoma, or any other cancer, autoimmune disease such as lupus, which is in and of itself a cause of immunosuppression to the point that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine.
- Currently receiving systemic immunosuppressive chemotherapy or immunotherapy (including glucocorticoids) resulting in immune suppression to the point that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine.
- Any neurological condition in which (in the opinion of the Investigator) the integrity of the blood brain barrier may have been compromised.
- Licensed vaccines are not exclusionary but should be given at least 14 days before or after immunization (applies to each of the 3 scheduled TBEV injections) for inactivated vaccines and 30 days before or after immunization with any live vaccines. This is in order to avoid potential confusion of adverse reactions. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case-by-case basis after discussion between the Investigator and the IRB.).
- Previous anaphylactic reaction to any TBE vaccine.
- Known or suspected anaphylactic reaction to any constituent of FSME IMMUN, to include formaldehyde, protamine sulfate, gentamicin and neomycin, or current egg allergy.
- Known pregnancy, or anticipating becoming pregnant in the first 8 months of the study or a positive urine beta-human chorionic gonadotropin (beta hCG) test result prior to immunization. If subjects become pregnant at some point in time after the 1st injection, no further injections will be given until after the pregnancy is completed, they are no longer nursing or have a negative beta-hCG result.
- Lactating or nursing.
- Women of child bearing potential (defined as pre-menopausal who have not undergone either hysterectomy or tubal ligation) who lack a history of reliable contraceptive practices. Reliable contraceptive practices (for the first 8 months of the study and within 21 days prior to or 42 days after booster immunizations) include:
- Consistent abstinence from heterosexual activity
- Consistent use of combined or progestogen oral contraceptives
- Injectable progestogen
- Implants of levonorgestrel
- Estrogen or estrogen/progestogen vaginal ring
- Percutaneous contraceptive patches
- Intrauterine device (IUD) or intrauterine system (IUS)
- Successful vasectomy of the sole male partner, or
- Double barrier method (condom or occlusive cap plus spermicidal agent)
- A history of a prior infection with TBEV or previously receiving a TBE vaccine will not be considered as an exclusionary criterion for immunization through this protocol. However, these subjects antibody titer data will not be included in the statistical analysis.
- Any other conditions, which in the Investigator s judgment, might result in an increased risk to the subject, or would affect their participation in the study. Additionally the Investigator has the ability to exclude a subject if for any reason he/she feels the subject is not a good candidate for the study or will not be able to follow study procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Rocky Mountain Laboratory (RML)
Hamilton, Montana, 59840
About this study
Official title: A Phase II, Open Label Trial of a Vaccine (FSME-IMMUN 0.5 mL) Against Tick-Borne Encephalitis (TBE) for NIAID Workers Manipulating Tick-Borne Encephalitis Virus (TBEV) in the Laboratory
This was an open label trial of a non-US licensed vaccine for tick-borne encephalitis. The vaccine was licensed by Baxter, and now following an acquisition by Pfizer Inc in Vienna, Austria since 2001, and has an extensive safety record in multiple European countries. Field effectiveness studies suggest > 99 percent protection against disease transmitted by the natural routes of either tick bite or ingestion of contaminated, unpasteurized milk. The vaccine is also considered to be effective against laboratory exposures and is used routinely for this purpose in European laboratories. The US Centers for Disease Control and Prevention and the National Institutes of Health acknowledge the effectiveness of the vaccine by allowing those who have received it to study tick-borne encephalitis virus (TBEV) in isolation facilities rated at BSL-3 rather than the more stringent BSL-4, with the exception of the Russian Spring-Summer Encephalitis strain. Subjects were recruited from personnel at 2 intramural campuses of the National Institute of Allergy and Infectious Diseases who may be exposed accidentally to any strain or serotype of viable TBEV. Approximately 160 individuals were eligible to participate. The rapid immunization schedule (injections on Days 0, 14, and 161) was used and subjects had labs drawn 21 days after the 2nd, 3rd and 4th vaccine injections to determine seroconversion. Subjects that seroconverted to TBEV were offered a booster dose of the vaccine 3 years from the date of receipt of the third dose of the vaccine. Subjects that were seropositive at entry into the study were offered a booster dose of the vaccine every 3 years from Day 0.
Read the detailed description
Infection by tick-borne encephalitis virus (TBEV) is a significant health concern for humans in Europe and Asia. A vaccine is available in these regions and in Canada, but not in the United States. Research studies in Europe have shown the vaccine to be effective in preventing infection among the general population, where disease is transmitted either by the bite of an infected tick (most common) or by ingestion of contaminated unpasteurized milk or milk products. Persons who work with the virus in a research setting, however, have the potential of being exposed in unnatural ways, and may come into contact with concentrations of virus higher than those found naturally in ticks. The Food and Drug Administration is investigating the effectiveness of the existing vaccine. It is a killed vaccine, which means that it has been treated to ensure that it does not contain live agents (bacteria or virus). The manufacturer has tested the product for other possible contaminating agents and none have been detected. However, there is an unknown but small risk of exposure to undetected contaminating agents in the vaccine. This was an open label trial of a non-US licensed vaccine for tick-borne encephalitis. The vaccine has been licensed by Baxter, and now following an acquisition by Pfizer Inc in Vienna, Austria since 2001, and has an extensive safety record in multiple European countries. Field effectiveness studies suggest > 99 percent protection against disease transmitted by the natural routes of either tick bite or ingestion of contaminated, unpasteurized milk. The vaccine is also considered to be effective against laboratory exposures and is used routinely for this purpose in European laboratories. The US Centers for Disease Control and Prevention and the National Institutes of Health acknowledge the effectiveness of the vaccine by allowing those who have received it to study tick-borne encephalitis virus (TBEV) in isolation facilities rated at BSL-3 rather than the more stringent BSL-4, with the exception of the Russian Spring-Summer Encephalitis strain.
Subjects were recruited from personnel at 2 intramural campuses of the National Institute of Allergy and Infectious Diseases who may be exposed accidentally to any strain or serotype of viable TBEV. Approximately 160 individuals were eligible to participate.
Objectives: To test the safety and immune response to a vaccine against tick-borne encephalitis virus (TBEV). To add a level of protection to persons who may have occupational exposure to TBEV to reduce their chances of developing infection from that exposure.
Eligibility: Individuals 18 years of age or older who are in generally good health and have the potential for occupational exposure to TBEV at one of the two National Institute of Allergy and Infectious Diseases campuses.
Design: The full series of the vaccine included at least three doses by injection in the upper arm. The first and third dose of study vaccine were given in the muscle of the nondominant arm. The second dose was given in the dominant arm. Participation included at least 12 scheduled visits to the study center over approximately 3.5 years. An initial visit took place 7 to 21 days prior to the first injection. Blood samples were taken to test liver and kidney function, baseline antibody levels, and for possible pregnancy in female participants. Vaccine doses were given on days 0, 14, and 161. Participants were asked to complete a diary card on each day for one week following the vaccination to assess any reactions or side effects. At each visit after receipt of a vaccine, participants were asked about any side effects. Blood was drawn 14 days after the second injection and 21 days after the third injection in order to measure the level of antibodies and overall response to the vaccine. Subjects that developed a sufficiently high level of antibodies may (at the discretion of the laboratory chief) be allowed to work with strains of TBEV at Biosafety Level (BSL) 3 rather than BSL-4. Blood was drawn annually for 3 years to determine antibody level and response to the vaccine. Booster doses were provided if required.
- Conditions
- Tick-Borne Encephalitis, Encephalitis, Tick-Borne, Tick-Borne Disease, Glycoprotein E, Flavivirus, NSI Protein, Flavivirus
- Being tested
- FSME-IMMUN 0.5ml Baxter
- Keywords
- FSME-Immun, TBEV, TBE Researcher, Plavivirus, Anti-TBEV Levels, Tic-Borne Encephalitis
- Medical subject headings
- Encephalitis, Tick-Borne, Tick-Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSME-IMMUN 0.5ml BaxterBiological
Vaccine
| Study group | Role | What they receive |
|---|---|---|
| FSME-IMMUN 0.5mL Baxter | Other | FSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis virus. 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 virus 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. Receives: Biological: FSME-IMMUN 0.5ml Baxter |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBEV Viral Neutralization Titer >1:10
Tick borne encephalitis antibody viral neutralization titer levels (>1:10)
Measured: Baseline
TBEV Viral Neutralization Titer >1:10
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start25 Sep 2009
- Primary completion23 Dec 2016
- Study completion23 Dec 2016
Why it stopped: Manufacturer discontinued support of the study
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 (3)Papers the sponsor has linked to this study.
- Other trials for Tick-Borne EncephalitisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- James M Schmitt, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031537
- Sponsor's protocol ID
- 090246
- Other IDs
- 09-I-0246
- Acronym
- TBEV
- Status last verified
- Apr 2018
- First submitted
- 11 Dec 2009
- Last updated
- 5 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Adner N, Leibl H, Enzersberger O, Kirgios M, Wahlberg T. Pharmacokinetics of human tick-borne encephalitis virus antibody levels after injection with human tick-borne encephalitis immunoglobulin, solvent/detergent treated, FSME-BULIN S/D in healthy volunteers. Scand J Infect Dis. 2001;33(11):843-7. doi: 10.1080/00365540110027358.
PubMed 11760166Baumhackl U, Franta C, Retzl J, Salomonowitz E, Eder G. A controlled trial of tick-borne encephalitis vaccination in patients with multiple sclerosis. Vaccine. 2003 Apr 1;21 Suppl 1:S56-61. doi: 10.1016/s0264-410x(02)00815-0.
PubMed 12628815Charrel RN, Attoui H, Butenko AM, Clegg JC, Deubel V, Frolova TV, Gould EA, Gritsun TS, Heinz FX, Labuda M, Lashkevich VA, Loktev V, Lundkvist A, Lvov DV, Mandl CW, Niedrig M, Papa A, Petrov VS, Plyusnin A, Randolph S, Suss J, Zlobin VI, de Lamballerie X. Tick-borne virus diseases of human interest in Europe. Clin Microbiol Infect. 2004 Dec;10(12):1040-55. doi: 10.1111/j.1469-0691.2004.01022.x.
PubMed 15606630
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label Trial of a Vaccine (FSME-IMMUN 0.5 mL) Against Tick-Borne Encephalitis (TBE) for NIAID Workers Manipulating Tick-Borne Encephalitis Virus (TBEV) in the Laboratory
- ClinicalTrials.gov ID
- NCT01031537
- Acronym / sponsor ID
- TBEV / 090246
- Conditions
- Tick-Borne Encephalitis, Encephalitis, Tick-Borne, Tick-Borne Disease, Glycoprotein E, Flavivirus, NSI Protein, Flavivirus
- Keywords
- FSME-Immun, TBEV, TBE Researcher, Plavivirus, Anti-TBEV Levels, Tic-Borne Encephalitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Manufacturer discontinued support of the study
- Enrolment
- 69 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 25 Sep 2009
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 14 Dec 2009 (estimated)
- Results
- Posted 5 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an open label trial of a non-US licensed vaccine for tick-borne encephalitis. The vaccine was licensed by Baxter, and now following an acquisition by Pfizer Inc in Vienna, Austria since 2001, and has an extensive safety record in multiple European countries. Field effectiveness studies suggest > 99 percent protection against disease transmitted by the natural routes of either tick bite or ingestion of contaminated, unpasteurized milk. The vaccine is also considered to be effective against laboratory exposures and is used routinely for this purpose in European laboratories. The US Centers for Disease Control and Prevention and the National Institutes of Health acknowledge the effectiveness of the vaccine by allowing those who have received it to study tick-borne encephalitis virus (TBEV) in isolation facilities rated at BSL-3 rather than the more stringent BSL-4, with the exception of the Russian Spring-Summer Encephalitis strain. Subjects were recruited from personnel at 2 intramural campuses of the National Institute of Allergy and Infectious Diseases who may be exposed accidentally to any strain or serotype of viable TBEV. Approximately 160 individuals were eligible to participate. The rapid immunization schedule (injections on Days 0, 14, and 161) was used and subjects had labs drawn 21 days after the 2nd, 3rd and 4th vaccine injections to determine seroconversion. Subjects that seroconverted to TBEV were offered a booster dose of the vaccine 3 years from the date of receipt of the third dose of the vaccine. Subjects that were seropositive at entry into the study were offered a booster dose of the vaccine every 3 years from Day 0.
Detailed description
Infection by tick-borne encephalitis virus (TBEV) is a significant health concern for humans in Europe and Asia. A vaccine is available in these regions and in Canada, but not in the United States. Research studies in Europe have shown the vaccine to be effective in preventing infection among the general population, where disease is transmitted either by the bite of an infected tick (most common) or by ingestion of contaminated unpasteurized milk or milk products. Persons who work with the virus in a research setting, however, have the potential of being exposed in unnatural ways, and may come into contact with concentrations of virus higher than those found naturally in ticks. The Food and Drug Administration is investigating the effectiveness of the existing vaccine. It is a killed vaccine, which means that it has been treated to ensure that it does not contain live agents (bacteria or virus). The manufacturer has tested the product for other possible contaminating agents and none have been detected. However, there is an unknown but small risk of exposure to undetected contaminating agents in the vaccine. This was an open label trial of a non-US licensed vaccine for tick-borne encephalitis. The vaccine has been licensed by Baxter, and now following an acquisition by Pfizer Inc in Vienna, Austria since 2001, and has an extensive safety record in multiple European countries. Field effectiveness studies suggest > 99 percent protection against disease transmitted by the natural routes of either tick bite or ingestion of contaminated, unpasteurized milk. The vaccine is also considered to be effective against laboratory exposures and is used routinely for this purpose in European laboratories. The US Centers for Disease Control and Prevention and the National Institutes of Health acknowledge the effectiveness of the vaccine by allowing those who have received it to study tick-borne encephalitis virus (TBEV) in isolation facilities rated at BSL-3 rather than the more stringent BSL-4, with the exception of the Russian Spring-Summer Encephalitis strain.
Subjects were recruited from personnel at 2 intramural campuses of the National Institute of Allergy and Infectious Diseases who may be exposed accidentally to any strain or serotype of viable TBEV. Approximately 160 individuals were eligible to participate.
Objectives: To test the safety and immune response to a vaccine against tick-borne encephalitis virus (TBEV). To add a level of protection to persons who may have occupational exposure to TBEV to reduce their chances of developing infection from that exposure.
Eligibility: Individuals 18 years of age or older who are in generally good health and have the potential for occupational exposure to TBEV at one of the two National Institute of Allergy and Infectious Diseases campuses.
Design: The full series of the vaccine included at least three doses by injection in the upper arm. The first and third dose of study vaccine were given in the muscle of the nondominant arm. The second dose was given in the dominant arm. Participation included at least 12 scheduled visits to the study center over approximately 3.5 years. An initial visit took place 7 to 21 days prior to the first injection. Blood samples were taken to test liver and kidney function, baseline antibody levels, and for possible pregnancy in female participants. Vaccine doses were given on days 0, 14, and 161. Participants were asked to complete a diary card on each day for one week following the vaccination to assess any reactions or side effects. At each visit after receipt of a vaccine, participants were asked about any side effects. Blood was drawn 14 days after the second injection and 21 days after the third injection in order to measure the level of antibodies and overall response to the vaccine. Subjects that developed a sufficiently high level of antibodies may (at the discretion of the laboratory chief) be allowed to work with strains of TBEV at Biosafety Level (BSL) 3 rather than BSL-4. Blood was drawn annually for 3 years to determine antibody level and response to the vaccine. Booster doses were provided if required.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FSME-IMMUN 0.5mL Baxter | Other | Biological: FSME-IMMUN 0.5ml BaxterFSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis virus. 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 virus 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be engaged in activities that place them at potential risk of occupational exposure to TBEV in its viable form at one of the participating intramural laboratories of NIAID
- Be 18 years of age or older at the time of the first immunization.
- Comprehend the study requirements.
- Provide written informed consent to participate in this study.
- Be in good health as determined by the Investigator, based upon medical history and a targeted physical examination.
Key exclusion criteria (26 listed)
- The following criteria should be checked at the time of the study entry. If any apply, the subject will not be included in the study:
- The subject must not be participating in any other trial of an investigational drug or vaccine for 1 month prior to the first injection through until 21 days after the third injection. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case by case basis after discussion between the Investigator and the IRB.)
- The presence on the day of immunization of an oral temperature of >101.2 degrees F or acute symptoms other than mild severity.
- Active systemic infectious process as determined by review of systems and physical examination. The subject may be enrolled at a later date once the illness has resolved.
- Known immune suppression, such as that associated with human immunodeficiency virus infection, or other condition, to the extent that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine. This information will be obtained by history only. Serologic screening for these diseases will not be performed.
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 |
|---|---|---|
| FSME-IMMUN 0.5ml BaxterVaccine | Biological | FSME-IMMUN 0.5mL Baxter |
Primary outcome
TBEV Viral Neutralization Titer >1:10
Time frame: Baseline
Tick borne encephalitis antibody viral neutralization titer levels (>1:10)
TBEV Viral Neutralization Titer >1:10
Time frame: 6 months
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11760166Adner N, Leibl H, Enzersberger O, Kirgios M, Wahlberg T. Pharmacokinetics of human tick-borne encephalitis virus antibody levels after injection with human tick-borne encephalitis immunoglobulin, solvent/detergent treated, FSME-BULIN S/D in healthy volunteers. Scand J Infect Dis. 2001;33(11):843-7. doi: 10.1080/00365540110027358.
- Background: PubMed 12628815Baumhackl U, Franta C, Retzl J, Salomonowitz E, Eder G. A controlled trial of tick-borne encephalitis vaccination in patients with multiple sclerosis. Vaccine. 2003 Apr 1;21 Suppl 1:S56-61. doi: 10.1016/s0264-410x(02)00815-0.
- Background: PubMed 15606630Charrel RN, Attoui H, Butenko AM, Clegg JC, Deubel V, Frolova TV, Gould EA, Gritsun TS, Heinz FX, Labuda M, Lashkevich VA, Loktev V, Lundkvist A, Lvov DV, Mandl CW, Niedrig M, Papa A, Petrov VS, Plyusnin A, Randolph S, Suss J, Zlobin VI, de Lamballerie X. Tick-borne virus diseases of human interest in Europe. Clin Microbiol Infect. 2004 Dec;10(12):1040-55. doi: 10.1111/j.1469-0691.2004.01022.x.
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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.
James M Schmitt, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FSME-IMMUN 0.5ml Baxter in people with Tick-Borne Encephalitis and Encephalitis, Tick-Borne, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
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 9 inclusion and 26 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: stopped early, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 Jul 2018). 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?
TBEV Viral Neutralization Titer >1:10 (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT01031537, which also lists 3 linked publications.
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 5 Jul 2018.