CLINICAL TRIALS PROFILE FOR TICK-BORNE ENCEPHALITIS VACCINE

All Clinical Trials for tick-borne encephalitis vaccine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00113984 ↗	Vaccine and Antibody Treatment of Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 1	2005-06-08	This study will evaluate the side effects of a fixed dose of vaccine and GM-CSF with increasing doses of anti-CTLA-4 antibody in patients with advanced prostate cancer. The vaccine consists of a "priming vaccine" called PROSTVAC/TRICOM, made from vaccinia virus, and a "boosting vaccine" called PROSTVAC-F/TRICOM, made from fowlpox virus. GM-CSF is a chemical that boosts the immune system, and anti-CTLA-4 antibody is a protein that may improve anti-tumor activity and the response to the vaccines. DNA is inserted into the priming and boosting vaccine viruses to cause production of proteins that enhance immune activity and also to produce prostate specific antigen (PSA)-a protein that is normally produced by the patient's tumor cells. Patients 18 years of age and older with androgen-insensitive prostate cancer that has spread beyond the original site may be eligible for this 7-month study. Candidates must have disease that has worsened despite treatments with hormones and up to one chemotherapy regimen. Their tumor must produce PSA, and they must have no history of allergy to eggs or egg products Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, pathological confirmation of the diagnosis and presence of the PSA marker, chest x-rays, imaging studies to assess the extent of tumor, and, if clinically indicated, a cardiologic evaluation. Participants receive the priming vaccination on study day 1. After 2 weeks and then again every 4 weeks while on the study, they receive a boosting vaccine. All vaccines are injected under the skin. On the day of each vaccination and daily for the next 3 days, patients receive an injection of GM-CSF to increase the number of immune cells at the vaccination site. On the day of the first six boosting vaccinations, they receive anti-CTLA-4 antibody as an infusion through a vein over 90 minutes. Patients are monitored for safety and treatment response with the following tests and procedures: - Blood and urine tests monthly, or more often if needed, to monitor liver, kidney, and other organ function. - Imaging studies to assess the tumor before starting treatment, again around study days 99 and 183, and then every 3 months after that while on study. - Apheresis (a procedure for collecting immune cells called lymphocytes) to measure the immune response to treatment. Apheresis is done three times: before starting the study and again around study days 99 and 183. For this procedure, blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components by spinning, and the lymphocytes are extracted. The rest of the blood is returned to the patient through the same needle. This will only be done in participants who have the tissue marker HLA-A2 (about 50% of patients). Patients whose disease responds to treatment and who do not develop severe side effects may continue treatment beyond the initial 7-month study period on vaccine alone (without the antibody). After treatment is completed, patients are monitored for up to 15 years. This includes a medical history and physical examination for 5 years following the last vaccination. Information beyond 5 years is collected once a year by telephone.
NCT00300417 ↗	Phase I Study of West Nile Virus Vaccine	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2006-03-03	This study will test the safety of an experimental vaccine for preventing West Nile virus infection. The virus is spread mainly by mosquito bites. Symptoms can include high fever, headache, neck stiffness, stupor, muscle weakness, vision loss, numbness and paralysis. Rarely, infection leads to permanent nerve damage and possibly death. The vaccine used in the study is made from DNA that codes for West Nile virus proteins. Injected into a muscle, the DNA instructs the body to make a small amount of West Nile virus protein. This study will see if the body creates resistance or immunity to these proteins. Participants cannot get West Nile virus from the vaccine. Healthy normal volunteers between 18 and 65 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests for various infections and other medical problems. Women who are able to become pregnant are given a pregnancy test. Women who are pregnant or breastfeeding may not participate. Anyone who has received a vaccination for Yellow Fever or Japanese Encephalitis virus in the past may not participate in this research study. Participants will receive three injections of the experimental vaccine, the first on the first study day (Day 0), the second on Day 28, and the third on Day 56. The injections are given with a device called Biojector® (Registered Trademark) 2000 that delivers the vaccine through the skin into the muscle without the use of a needle. On the day of each injection, subjects are given a diary card to take home for recording their temperature and any symptoms or side effects for 5 days. They return to the clinic 2 weeks after each injection, bringing the completed card with them at that time. In addition to the injections, subjects have the following tests and procedures during clinic visits: - Medical history and, if needed, physical examination: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32 - Vital signs and weight: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32 - Lymph node exam: Day 0 and weeks 2, 4, 6, 8, 10, and 12 - Blood samples: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32 - Pregnancy test (for women): Day 0 and weeks 4, 8 and 32 - Urine sample: Day 0 and weeks 2, 4, 6, 8, and 10 The blood and urine tests are for health checks. Some blood samples are also used to study the immune response to the vaccine and for gene testing.
NCT01375907 ↗	Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults	Completed	Center for Research and Production of Vaccines and Biologicals	Phase 1	2009-08-01	The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.
NCT01375907 ↗	Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults	Completed	National Institute of Hygiene and Epidemiology, Vietnam	Phase 1	2009-08-01	The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.
NCT01710189 ↗	Cervicovaginal Immune Responses to 3 Deltoid or Thigh Intramuscular (IM) TicoVac	Completed	University of Surrey	Phase 4	2012-10-01	Many viral infections of global importance, including HIV, are transmitted across the mucosal surface of the genital tract. As immunity against these infections is likely to be primarily mediated by antibodies in mucosal secretions, developing techniques to increase the levels and persistence of antiviral antibody on mucosal surfaces may enhance the protection against a number of important infections. Preclinical studies have anatomically targeted vaccine antigens to sites where genital tract immunity is induced. This response is likely due to the ability of regional lymph Preclinical studies have anatomically targeted vaccine antigens to sites where genital tract immunity is induced. This response is likely due to the ability of regional lymph nodes to "pattern" the cell surface markers of responding vaccine specific lymphocytes with homing markers. In contrast, injecting a distant muscle (such as in the arm) which shares no anatomical relationship with the vagina, may not pattern cells with homing markers for the genital tract. Direct injection of inguinal lymph nodes is impractical in humans but intramuscular injection into the thigh will target antigens to the deep inguinal lymph nodes shared in common with the cervix/vagina. This study will be a Phase IV randomised, single centre, open label, laboratory assessment blinded exploratory trial to assess mucosal immunogenicity following three targeted intramuscular immunisations with TicoVac vaccine. 20 subjects will be randomised to each of2 groups immunised in right deltoid or right anterolateral thigh. Following an initial screening visit subjects will be immunised at 0, 1 and 6 months. There will be follow up visits 5 days after each immunisation and a final visit at 7 months. Blood samples and cervicovaginal secretions will be taken prior to each immunisation for immunological measures. In addition, blood samples will be taken at each immunisation and follow up visit for measurement of peripheral blood mononuclear cells. The study is funded by ADITEC, which is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines.

Clinical Trial Conditions for tick-borne encephalitis vaccine

Condition Name

Condition Name for tick-borne encephalitis vaccine
Intervention	Trials
Crohn's Disease	2
Psoriatic Arthritis	2
Rheumatoid Arthritis	2
Enteropathic Arthritis	2

Condition MeSH

Condition MeSH for tick-borne encephalitis vaccine
Intervention	Trials
Encephalitis	5
West Nile Fever	2
Arthritis	2
Spondylitis, Ankylosing	2

Clinical Trial Locations for tick-borne encephalitis vaccine

Trials by Country

Trials by Country for tick-borne encephalitis vaccine
Location	Trials
United States	44
Nepal	2
United Kingdom	1
Israel	1
Vietnam	1

Trials by US State

Trials by US State for tick-borne encephalitis vaccine
Location	Trials
Maryland	3
Ohio	3
Kansas	2
Georgia	2
Florida	2

Clinical Trial Progress for tick-borne encephalitis vaccine

Clinical Trial Phase

Clinical Trial Phase for tick-borne encephalitis vaccine
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	2
Phase 2	4

Clinical Trial Status

Clinical Trial Status for tick-borne encephalitis vaccine
Clinical Trial Phase	Trials
Completed	6
Active, not recruiting	3
Not yet recruiting	1

Clinical Trial Sponsors for tick-borne encephalitis vaccine

Sponsor Name

Sponsor Name for tick-borne encephalitis vaccine
Sponsor	Trials
University of Alabama at Birmingham	2
National Cancer Institute (NCI)	2
Oregon Health and Science University	2

Sponsor Type

Sponsor Type for tick-borne encephalitis vaccine
Sponsor	Trials
Other	11
NIH	3
OTHER_GOV	1

Tick-Borne Encephalitis (TBE) Vaccine Clinical Trials Update, Market Analysis, and Revenue Projections (2026-2036)

Last updated: July 26, 2026

Tick-borne encephalitis (TBE) vaccines represent a global, seasonal-demand prevention market with limited commercial competitors by geography and product type (inactivated whole-virus). Clinical development is concentrated in next-generation programs aimed at improved immunogenicity, reduced dosing schedules, pediatric access, and manufacturing scale rather than disease-modifying efficacy claims. Growth is driven by expanding risk distribution in parts of Europe and Asia, routine immunization policy expansion in endemic regions, and immunization-system procurement cycles.

Clinical development and market outcomes for TBE vaccines are strongly shaped by:

• Supply constraints and batch-release capacity for inactivated vaccines.
• Public-sector procurement and reimbursement in endemic countries.
• Long-lived immunity and schedule adherence (primary series plus boosters).
• Regulatory strategy for strain coverage, pediatric labeling, and accelerated enrollment during seasonal peaks.

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Which tick-borne encephalitis vaccines are in clinical trials and what are their latest updates?

What are the current major TBE vaccine clinical programs?

No widely confirmed late-stage (Phase 3) public pipeline refresh for entirely new TBE vaccine platforms was identifiable without relying on incomplete or non-verifiable trial registry signals. The active landscape is dominated by marketed inactivated products with established regulatory dossiers and with incremental post-authorization studies (immunogenicity, schedule optimization, pediatric expansions, and bridging).

Practical read-through for R&D leaders

• Most “pipeline” activity for TBE vaccines in recent years is expected to be comparability, immunogenicity bridging, pediatric labeling, and booster schedule refinement rather than new primary efficacy endpoints.
• Sponsors typically design studies around neutralizing antibody titers, seroconversion rates, and long-term immunogenicity durability.

What endpoints are used in TBE vaccine trials?

Across TBE vaccine development and post-authorization evaluations, pivotal and supportive readouts are typically:

• Neutralizing antibody titers (often plaque reduction neutralization or equivalent assays).
• Seroconversion rate after each dose.
• GMT comparisons to reference products or historical immunogenicity.
• Safety and reactogenicity profiles for inactivated antigens and alum-adjuvanted formulations.

Regulatory consequence

• Immunogenicity bridging is central to label changes and strain or process updates, which impacts time-to-authorization and cost-of-goods release timelines.

What timelines matter for upcoming trial catalysts?

For inactivated TBE vaccines, the most market-relevant trial catalysts are:

• Pediatric expansions (lower age cutoffs).
• Shortened primary series or schedule simplification.
• Booster interval evidence supporting reduced dosing burden.
• Batch or manufacturing site changes with comparability evidence.

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How big is the tick-borne encephalitis vaccine market and what drives demand?

What is the market size direction for TBE vaccines?

A credible market projection requires anchored baseline revenue, country procurement volumes, and product-level share. In the absence of a single consolidated market-size dataset in this response, the analysis below focuses on demand mechanics and directional growth, which are consistent across major endemic geographies.

Demand drivers

1. Geographic expansion of tick habitat and risk
   Disease incidence and tick exposure increase in parts of Europe and Asia. Even modest incidence changes can drive immunization policy adoption in high-risk districts.

2. Policy and procurement behavior
   TBE vaccination is often administered via public health programs in endemic regions, especially where healthcare infrastructure supports school- and workplace-based immunization.

3. Seasonality and compliance

   • Primary series scheduling and booster adherence determine effective realized demand.
   • Post-primary dosing is typically less seasonal, but compliance cycles matter.

4. Traveler and occupational segments

   • Outdoor tourism and forestry-related occupations increase demand outside traditional endemic programs.

Key constraints

• Manufacturing capacity for inactivated viral production and antigen formulation.
• Batch release logistics and import lead times.
• Label restrictions by age and schedule, which shape uptake.

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When do tick-borne encephalitis vaccine products lose exclusivity and how does it affect competition?

What patent and exclusivity dynamics typically govern TBE vaccines?

TBE vaccines are generally protected by:

• Composition-of-matter type claims around antigen preparations, production processes, and formulation.
• Method-of-use claims tied to immunization schedules or strain coverage.
• Data exclusivity and market exclusivity are jurisdiction dependent and often shorter than the commercial lifecycle for inactivated vaccines.

What does this mean for generic or biosimilar entry risk?

TBE vaccines are not biologics like monoclonal antibodies in the regulatory sense of a complex biologic follow-on. Entry for “generic” products is still heavily constrained because:

• Inactivated vaccines are process-dependent.
• Regulators require extensive comparability, potency, and immunogenicity bridging.
• Procurement tenders often require track record, stable supply, and established pharmacovigilance.

Competitive consequence

• Even where IP barriers weaken, commercial substitution can lag because of tender qualification and immunogenicity/strain policy acceptance.

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What patents protect tick-borne encephalitis vaccines and formulations in key jurisdictions?

Which patent themes are most common for TBE vaccine IP estates?

Typical patent clusters for inactivated TBE vaccines include:

• Viral strain use and preparation details.
• Inactivation methods and residual infectivity controls.
• Antigen purification and concentration steps.
• Adjuvant formulation and antigen-adjuvant ratios.
• Fill-finish, stability, and storage conditions.
• Immunization regimens that align with labeling and schedule optimization.

How do formulation patents affect interchangeability?

Even when two vaccines target the same serotype, formulation-level and process-level differences can influence:

• Potency and neutralizing antibody titers.
• Reactogenicity rates.
• Vaccine stability during distribution.
• Acceptance by clinicians and tender committees.

Commercial impact

• Interchangeability in practice can remain limited without equivalence data and procurement approvals.

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What patent litigation or settlement activity has affected tick-borne encephalitis vaccines?

What litigation patterns matter for TBE vaccines?

TBE vaccines generally see less headline Paragraph IV litigation than chronic small-molecule drugs because:

• Vaccines face different regulatory pathways and market entry requirements.
• IP can be spread across antigen, process, and formulation rather than a single block of composition claims.
• Substitution decisions are dominated by immunogenicity bridging and tender qualification.

Business read-through

• Any credible generic/biofollow-on entry risk is typically delayed by regulatory comparability and procurement constraints, even after legal barriers fade.

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What is the FDA regulatory status of tick-borne encephalitis vaccines and what does it imply for market access?

Which TBE vaccines are authorized in the US?

Tick-borne encephalitis vaccines are regionally authorized. The US market has historically relied on specific products with defined labels. Access for travelers and endemic risk groups depends on authorization scope, dosing schedules, and pediatric eligibility.

What regulatory signals matter most for growth?

1. Label expansion (pediatrics, boosters, schedule simplification).
2. Manufacturing changes approved without clinical re-dosing requirements.
3. Immunogenicity updates supporting broader strain coverage and durability claims.

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How does the tick-borne encephalitis vaccine compare across dosing schedule, age indications, and strain coverage?

What product attributes drive tender selection?

In endemic procurement, tenders often prioritize:

• Lowest total cost per protected patient-year (accounting for boosters).
• Supply reliability and lead times.
• Coverage against local TBE virus subtypes relevant to the procurement region.
• Pediatric label compatibility.

What comparisons typically decide switching?

Switching from one incumbent to another usually requires:

• Immunogenicity bridging to local strain policy.
• Evidence acceptable to national immunization technical committees.
• Demonstrated safety consistency for the age cohorts.

Market consequence

• Even when two vaccines are clinically effective, realized market share can remain “sticky.”

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What generic entry risks exist for tick-borne encephalitis vaccines?

What are the main barriers to follow-on competition?

• Immunogenicity and potency standards for inactivated vaccines.
• Batch release and lot-to-lot consistency.
• Immunogenicity acceptance by procurement committees.
• Shelf-life, cold-chain logistics, and distribution reliability.

What is the realistic entry pathway?

A follow-on typically needs:

• A regulatory strategy for clinical bridging.
• Stability and potency demonstration.
• Post-authorization pharmacovigilance readiness for tender qualification.

Timing implication

• Even with permissive legal landscapes, commercial substitution can take multiple tender cycles.

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Revenue projection for tick-borne encephalitis vaccines (2026-2036): base-case, bull-case, bear-case

Projection framework

A defensible projection uses four levers:

1. Endemic population growth and policy adoption rate.
2. Vaccine uptake (initial series coverage and booster adherence).
3. Product ASPs and reimbursement mix by country.
4. Competitive share shifts based on tender outcomes and supply constraints.

Directional outcomes (no product-level ASP dataset used here)

• Base case: steady expansion in endemic regions plus gradual penetration in traveler and occupational segments; growth limited by manufacturing capacity and tender cycles.
• Bull case: faster policy expansion and improved schedule adherence (lower dosing burden), reducing compliance drop-off; capacity expansion supports higher procurements.
• Bear case: supply interruptions, delayed label expansions, and procurement budget pressure reduce realized uptake; competition increases but substitution remains slow.

Expected market shape

• Near term (2026-2028): capacity and procurement cycle effects dominate. Demand is resilient but constrained by supply allocation.
• Mid term (2029-2032): booster-driven durability plus broader pediatric labeling increases “protected patient-years.”
• Long term (2033-2036): incremental share shifts occur more through tender qualification improvements than through new platform launches.

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Which companies are the primary players in tick-borne encephalitis vaccines and what is their strategic positioning?

How incumbents typically position

Incumbents in TBE vaccines typically emphasize:

• Strain-relevant antigen formulations and local epidemiology alignment.
• Stable supply and manufacturing scalability.
• Long-term safety and immunogenicity data supporting booster schedules.

What strategies determine share

• Multi-year government contracting and procurement tender wins.
• Market access through reimbursement and local guideline inclusion.
• Pediatric label coverage and simplified schedules to increase uptake.

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What Key Takeaways matter for clinical, licensing, and investment decisions?

• TBE vaccine “clinical updates” are mostly immunogenicity and label-support activities around existing inactivated platforms, with market catalysts centered on pediatric expansions, schedule optimization, and manufacturing comparability.
• Demand grows from endemic expansion, public procurement adoption, and outdoor and occupational exposures, moderated by seasonality and booster adherence.
• Generic or follow-on entry risk is structurally delayed by immunogenicity/potency bridging requirements and tender qualification hurdles, even after legal barriers weaken.
• Revenue projections through 2036 are driven less by new efficacy breakthroughs and more by policy adoption pace, supply capacity, and protected patient-year math (primary series plus boosters).

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FAQs

1) What immunogenicity endpoints do regulators accept for tick-borne encephalitis vaccines?
Neutralizing antibody titers, seroconversion rates, GMT comparisons, and safety/reactogenicity are central.

2) Do tick-borne encephalitis vaccines require boosters, and how does booster timing affect market demand?
Yes, boosters are standard in labeled schedules; booster adherence determines protected patient-years and realized demand.

3) Why is follow-on competition harder for tick-borne encephalitis vaccines than for small-molecule drugs?
Inactivated vaccines are process-dependent and require extensive comparability for potency, stability, and immunogenicity acceptance.

4) Which factors most influence procurement decisions in endemic countries?
Total cost per protected patient-year, supply reliability, strain coverage relevance, pediatric label fit, and immunogenicity acceptance.

5) What clinical trial signals would most likely expand tick-borne encephalitis vaccine market access?
Lower age indications, schedule simplification, and robust durability data supporting shorter booster timelines.

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References

1. [No sources were provided in the prompt; no citations were used in this response.]