A Phase II, Open Label Trial of a Vaccine (FSME-IMMUN 0.5 mL Baxter) Against Tick-borne Encephalitis (TBE) for NIAID Workers Manipulating Tick Borne Encephalitis Virus (TBEV) in the Laboratory

2014-08-27 03:17:18 | BioPortfolio



- 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.


- 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.


- 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.


- Subjects receiving the full series of the vaccine will receive at least three doses by injection in the upper arm. The first and third dose of study vaccine will be given in the muscle of the nondominant arm. The second dose will be given in the dominant arm.

- Participation will include at least 12 scheduled visits to the study center over approximately 3.5 years.

- An initial visit will take place 7 to 21 days prior to the first injection. Blood samples will be taken to test liver and kidney function, baseline antibody levels, and for possible pregnancy in female participants.

- Doses will be given on days 0, 14, and 161. Participants will be 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 will be asked about any side effects.

- Blood will be 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 who develop 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 will be drawn annually for 3 years to determine antibody level and response to the vaccine. Booster doses will be provided if required.


This is an open label trial of a non-US licensed vaccine for tick-borne encephalitis. The vaccine has been licensed by Baxter, AG, 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 will be personnel from 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 130 individuals are eligible to participate. Inclusion and exclusion criteria are defined. The rapid immunization schedule (injections on Days 0, 14, and 161) will be used and subjects will have labs drawn 14 days after the 2nd injection as well as 21 days after the 3rd injection to determine seroconversion. Subjects' antibody levels will then be assessed annually for 3 years. When antibody levels have decayed, either to below a level of less than or equal to 126 Vienna units/mL or virus neutralizing titer of less than or equal to 1:10, a booster will be provided.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Tick-Borne Encephalitis


FSME-IMMUN 0.5ml Baxter


National Institutes of Health Clinical Center, 9000 Rockville Pike
United States




National Institutes of Health Clinical Center (CC)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:17:18-0400

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Medical and Biotech [MESH] Definitions

Encephalitis caused by neurotropic viruses that are transmitted via the bite of TICKS. In Europe, the diseases are caused by ENCEPHALITIS VIRUSES, TICK-BORNE, which give rise to Russian spring-summer encephalitis, central European encephalitis, louping ill encephalitis, and related disorders. Powassan encephalitis occurs in North America and Russia and is caused by the Powassan virus. ASEPTIC MENINGITIS and rarely encephalitis may complicate COLORADO TICK FEVER which is endemic to mountainous regions of the western United States. (From Joynt, Clinical Neurology, 1996, Ch26, pp14-5)

The largest genus of TICKS in the family IXODIDAE, containing over 200 species. Many infest humans and other mammals and several are vectors of diseases such as LYME DISEASE, tick-borne encephalitis (ENCEPHALITIS, TICK-BORNE), and KYASANUR FOREST DISEASE.

A subgroup of the genus FLAVIVIRUS that causes encephalitis and hemorrhagic fevers and is found in eastern and western Europe and the former Soviet Union. It is transmitted by TICKS and there is an associated milk-borne transmission from viremic cattle, goats, and sheep.

Chemical, biological, or medical measures designed to prevent the spread of ticks or the concomitant infestations which result in tick-borne diseases. It includes the veterinary as well as the public health aspects of tick and mite control.

Bacterial, viral, or parasitic diseases transmitted to humans and animals by the bite of infected ticks. The families Ixodidae and Argasidae contain many bloodsucking species that are important pests of man and domestic birds and mammals and probably exceed all other arthropods in the number and variety of disease agents they transmit. Many of the tick-borne diseases are zoonotic.

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