Vaccine Study for Tick-Borne Encephalitis Virus (TBEV)

Stopped early · Phase 2

Conditions studied: Tick-Borne Encephalitis, Encephalitis, Tick-Borne, Tick-Borne Disease, Glycoprotein E, Flavivirus, NSI Protein, Flavivirus

In brief

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.

Key facts

Study ID

NCT01031537

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

69

Starts

2009-09-25

Expected to finish

2016-12-23

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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.
• 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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Rocky Mountain Laboratory (RML) — Hamilton, Montana, United States

Full record on ClinicalTrials.gov

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