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Tick-Borne EncephalitisPhase 1NCT00118924

Safety of and Immune Response to a Tick-Borne Encephalitis Vaccine (LGT(TP21)/DEN4) in Healthy Adults

A Phase 1 study testing LGT(TP21)/DEN4 in people with Tick-Borne Encephalitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Tick-borne encephalitis (TBE) is a viral illness common in the Northern Hemisphere, especially Europe and Asia. TBE infection may lead to central nervous system problems and death. The purpose of this study is to test the safety of and immune response to a TBE vaccine in healthy adults. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Tick-Borne Encephalitis
What is being tested?
LGT(TP21)/DEN4
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteUnited States
Study dates
Jul 2005to Jul 2007
Phase
Phase 1
Are there results?
None posted in the registry

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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Willing and available to be followed for the duration of the study
  • Willing to use acceptable means of contraception
  • Good general health

Who cannot join

  • Pregnancy or breastfeeding
  • Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
  • Blood disease
  • History of migraine headaches
  • History of encephalitis
Show all 23Show fewer
  • Alcohol or drug use that has caused medical, occupational, or family problems within 12 months prior to study entry
  • History of severe allergic reaction or anaphylaxis
  • Emergency room visit or hospitalization for severe asthma within 6 months prior to study entry
  • HIV-1 infected
  • Hepatitis C virus infected
  • Hepatitis B surface antigen positive
  • Known immunodeficiency syndrome
  • Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
  • Live vaccine within 4 weeks prior to study entry
  • Killed vaccine within 2 weeks prior to study entry
  • Blood products within 6 months prior to study entry
  • Investigational drug or vaccine within 3 months prior to study entry
  • Previously received a licensed or experimental yellow fever, tick-borne encephalitis, or dengue vaccine
  • Surgical removal of spleen
  • History of tick-borne encephalitis
  • History of dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus, Japanese encephalitis virus)
  • Other condition that, in the opinion of the investigator, would affect the participant's participation in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University School of Medicine

    Nashville, Tennessee, 37232-2581

Other trials in United States

About this study

Official title: Phase 1 Study of the Safety and Immunogenicity of Tick-Borne Langat/Dengue 4 Chimera (LGT(TP21)/DEN4), a Live Attenuated Vaccine for Tick-Borne Encephalitis

Tick-borne encephalitis (TBE) is a viral illness common in the Northern Hemisphere, especially Europe and Asia. TBE infection may lead to central nervous system problems and death. The purpose of this study is to test the safety of and immune response to a TBE vaccine in healthy adults. The vaccine is related to a live attenuated virus developed against dengue virus infection.

Read the detailed description

TBE is a common illness in Europe and Asia, where it is usually associated with mild illness but sometimes leads to long-term symptoms and even death. This study will evaluate the safety and immunogenicity of a live attenuated chimeric virus, LGT(TP21)/DEN4, which is derived from the Langat flavivirus and DEN4 dengue virus serotypes.

Each volunteer will be involved in the study for 180 days. Participants in Cohort 1 will be randomly assigned to receive LGT(TP21)/DEN4 or placebo at study entry. Cohort 2 will begin only after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of LGT(TP21)/DEN4 or placebo.

After vaccination, participants will be asked to monitor their temperatures every day for 16 days and on Day 19. Study visits will occur every other day after vaccination until Day 16, followed by 5 additional visits at selected days through Day 180. Blood collection and a targeted physical exam will occur at each study visit. Some participants will be asked to undergo a skin biopsy or additional blood collection at selected visits.

Being tested
LGT(TP21)/DEN4, Placebo
Keywords
Dengue Vaccine, Tick-Borne Illnesses, Flavivirus
Medical subject headings
Encephalitis, Tick-Borne

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LGT(TP21)/DEN4Biological

    Live attenuated LGT(TP21)/DEN4 vaccine (one of two doses)

  • PlaceboBiological

    Placebo for LGT(TP21)/DEN4 vaccine

Study groups in NCT00118924
Study groupRoleWhat they receive
1ExperimentalOne subcutaneous vaccination with a 10^3 PFU dose of LGT(TP21)/DEN4 vaccine given in the deltoid region of either arm. A second booster vaccination will be given 6 months after the first vaccination.
Receives: Biological: LGT(TP21)/DEN4
2ExperimentalOne subcutaneous vaccination with a 10^5 PFU dose of LGT(TP21)/DEN4 vaccine given in the deltoid region of either arm. A second booster vaccination will be given 6 months after the first vaccination. This arm may enroll after Arm 1 depending on the immunological response of Arm 1.
Receives: Biological: LGT(TP21)/DEN4
3Placebo comparatorOne subcutaneous vaccination with a placebo vaccine given in the deltoid region of either arm. A second placebo vaccination will be given 6 months after the first vaccination.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of vaccine-related adverse effects, graded by intensity and severity through active and passive surveillance

    Measured: Throughout study

  2. Immunogenicity of vaccine against anti-Langat neutralizing antibody

    Measured: At Days 0, 28, 42, and 180

Secondary outcomes (3)

  1. Recovery of virus from the blood of a vaccinee or seroconversion

    Measured: Throughout study

  2. Immunogenicity of the LGT(TP21)/DEN4 vaccine against other TBE viruses

    Measured: Throughout study

  3. Durability of antibody responses to Langat and other TBE viruses

    Measured: At Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionJul 2007
  4. Study completionJul 2007

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00118924
Sponsor's protocol ID
CIR 182
Other IDs
H.22.03.09.26.B2
Status last verified
Jan 2008
First submitted
8 Jul 2005
Last updated
21 Jan 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Beran J. Immunisation against tick-borne encephalitis by widely used vaccines: short-term history and current recommendations. Clin Microbiol Infect. 2005 May;11(5):424-6. doi: 10.1111/j.1469-0691.2005.01115.x. No abstract available.

    PubMed 15819877

  • Chang GJ, Kuno G, Purdy DE, Davis BS. Recent advancement in flavivirus vaccine development. Expert Rev Vaccines. 2004 Apr;3(2):199-220. doi: 10.1586/14760584.3.2.199.

    PubMed 15056045

  • Lai CJ, Monath TP. Chimeric flaviviruses: novel vaccines against dengue fever, tick-borne encephalitis, and Japanese encephalitis. Adv Virus Res. 2003;61:469-509. doi: 10.1016/s0065-3527(03)61013-4.

    PubMed 14714441

  • Pletnev AG, Bray M, Hanley KA, Speicher J, Elkins R. Tick-borne Langat/mosquito-borne dengue flavivirus chimera, a candidate live attenuated vaccine for protection against disease caused by members of the tick-borne encephalitis virus complex: evaluation in rhesus monkeys and in mosquitoes. J Virol. 2001 Sep;75(17):8259-67. doi: 10.1128/jvi.75.17.8259-8267.2001.

    PubMed 11483771

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LGT(TP21)/DEN4 in people with Tick-Borne Encephalitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 3 inclusion and 23 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: finished, as of the sponsor's last update on 21 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Frequency of vaccine-related adverse effects, graded by intensity and severity through active and passive surveillance (time frame: Throughout study). 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 NCT00118924, which also lists 4 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 21 Jan 2008.

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