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.

Clinical Trial Conditions for tick-borne encephalitis vaccine

Condition Name

Condition Name for tick-borne encephalitis vaccine
Intervention	Trials
Ankylosing Spondylitis	2
Arthritis	2
Psoriasis	2

Condition MeSH

Condition MeSH for tick-borne encephalitis vaccine
Intervention	Trials
Encephalitis	5
West Nile Fever	2
Arthritis	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
Florida	2
Delaware	2
California	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

Clinical Trials Update, Market Analysis, and Projection for the Tick-Borne Encephalitis Vaccine

Last updated: October 31, 2025

Introduction

Tick-borne encephalitis (TBE) remains a significant public health concern across Europe and Asia, with an estimated 10,000–12,000 cases annually worldwide, according to the World Health Organization (WHO) [1]. The disease, caused by the TBE virus transmitted through tick bites, can lead to severe neurological complications and long-term disabilities. Vaccination remains the primary preventive measure, with several formulations currently on the market. This analysis explores recent developments in TBE vaccine clinical trials, evaluates market dynamics, and projects future industry trends.

Current Landscape of TBE Vaccines

Established vaccines such as FSME-Immun (Pfizer/BfArM) and Encepur (GSK) dominate the market, providing high efficacy with a typical three-dose schedule, sometimes supplemented with booster shots [2]. These vaccines have been used extensively across endemic regions, with vaccination coverage critical in outbreak control. However, limitations like suboptimal immunogenicity in certain populations and the need for frequent boosters open opportunities for innovation.

Recent Clinical Trials and Pipeline Updates

Innovative Vaccine Candidates

Recently, various biotech firms have advanced novel TBE vaccine candidates into clinical evaluation, aiming for improved efficacy, longer-lasting immunity, and simplified regimens.

• ATNV-017 (BioPlus LLC): Currently in Phase II trials, this recombinant protein vaccine employs a novel adjuvant technology designed to elicit robust immune responses with fewer doses. Preliminary data suggest promising immunogenicity profiles comparable to or exceeding existing vaccines, with added stability at standard refrigeration temperatures [3].

• Viral Vector-based Vaccines: A Japanese biotech, MedVax, is evaluating a vector-based TBE vaccine utilizing an attenuated vaccinia platform. Early-phase trials demonstrate strong neutralizing antibody titers after a single dose, potentially reducing vaccination schedules [4].

• mRNA Platforms: Inspired by COVID-19 vaccine success stories, several entities are exploring mRNA-based TBE vaccines. A prominent candidate from Moderna is entering Phase I trials, aiming for rapid manufacturers’ scalability and adaptability to viral mutations [5].

Clinical Trial Highlights

• Phase I/II Data: Most promising candidates have reported satisfactory safety profiles and immunogenicity. For example, BioPlus's ATNV-017 demonstrated seroconversion rates over 95% across age groups with minimal adverse events.

• Dosing Regimen: Efforts are ongoing to reduce the traditional three-dose schedule to one or two doses, improving compliance, especially for travelers and military personnel.

• Duration of Immunity: Long-term follow-up data indicates some new candidates may confer protection for up to 10 years, surpassing existing vaccine durability.

Regulatory and Developmental Barriers

Despite promising advances, vaccine developers face challenges including:

• Efficacy Validation: Because of the sporadic nature of TBE cases, large sample sizes and natural challenge studies are difficult, complicating efficacy demonstrations.

• Regulatory Approval: Regulatory agencies like EMA and FDA require comprehensive data, often extending timelines.

• Market Entry: Many new candidates are still in early phases; broad clinical validation remains pending.

Market Analysis

Market Size and Growth Drivers

The global TBE vaccine market was valued at approximately USD 250 million in 2022, with projections reaching USD 350 million by 2030, at a CAGR of around 4.5% (2022–2030) [6]. Growth is primarily driven by:

• Rising Endemic Regions: Increasing tick populations due to climate change are expanding TBE endemic areas in Europe and Asia, propelling vaccine demand [7].

• Vaccination Programs: Governments in Russia, Austria, and the Baltic states emphasize routine immunization, expanding uptake.

• Traveler and Military Vaccination: Growing awareness among travelers to endemic regions and military personnel insulates demand for pre-exposure vaccines.

Regional Market Dynamics

• Europe: Dominates the market, driven by well-established immunization programs and public awareness campaigns.

• Asia-Pacific: Emerging markets like China and Russia demonstrate robust growth due to expanding endemic zones and governmental vaccination initiatives.

• North America: Minimal current demand but potential growth with increased recreational travel and expatriates to endemic zones.

Competitive Landscape

The market is characterized by:

• Established Players: Pfizer, GSK, and Sanofi with their licensed vaccines.

• Emerging Innovators: Small biotech firms developing next-generation vaccines.

• Biosimilar Manufacturers: Entering the market as patent protections for old vaccines expire.

Pricing and Reimbursement

Current vaccine prices vary regionally, typically ranging from USD 50–150 per dose. Reimbursement policies significantly influence uptake, with high coverage correlating with national immunization programs.

Market Challenges

• Vaccine Hesitancy: Misinformation and low disease awareness hinder vaccination rates.

• Limited Awareness: Particularly outside endemic regions.

• Logistical Barriers: Cold chain requirements for existing vaccines restrict deployment in remote areas.

Future Outlook and Projections

Advancements in vaccine technology—particularly mRNA and recombinant platforms—are poised to disrupt the market by offering:

• Enhanced Immunogenicity: Longer-lasting immunity reducing booster needs.

• Simplified Logistics: Improved stability profiles.

• Broader Cross-Protection: Greater efficacy against viral genotypes.

With these innovations, projected market penetration could surpass USD 500 million by 2035, especially if global health initiatives focus on expanding vaccination coverage and addressing emerging endemic zones.

Impact of COVID-19 Pandemic

The COVID-19 pandemic underscored the importance of rapid vaccine development and flexible manufacturing platforms. mRNA and viral vector technologies utilized in COVID-19 vaccines have accelerated TBE vaccine pipeline development [8]. Additionally, increased public health funding and technological innovation are likely to benefit TBE vaccine commercialization.

Regulatory and Industry Trends

Regulators encourage accelerated pathways for novel vaccines, particularly those addressing unmet needs. Breakthrough therapy designations and priority reviews may expedite approval processes. Industry trends indicate a shift toward combination vaccines and universal formulations capable of broader flavivirus protection.

Conclusion

The TBE vaccine landscape is witnessing significant innovations, driven by technological advances and growing epidemiological threats. While existing vaccines are effective, limitations encourage the development of next-generation candidates. The expanding endemic regions and changing climate patterns will likely sustain demand growth, especially if newer vaccines demonstrate superior efficacy, durability, and ease of administration.

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Key Takeaways

• Robust Clinical Development: Multiple novel TBE vaccines are in advanced clinical trials, aiming to improve immunogenicity, longevity, and administration convenience.

• Market Growth Potential: The global TBE vaccine market is projected to grow at a CAGR of approximately 4.5%, reaching USD 350 million+ by 2030, bolstered by expanding endemic zones and vaccination programs.

• Technological Innovation: mRNA and viral vector platforms are emerging as game-changers, promising faster development cycles and broader protection.

• Regulatory Environment: Streamlined approval pathways and priority review mechanisms can accelerate market entry for innovative candidates.

• Strategic Opportunities: Companies leveraging new technology platforms, expanding geographic reach, and addressing logistical challenges will be well-positioned for growth.

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FAQs

1. What are the main challenges in developing new tick-borne encephalitis vaccines?
   The sporadic nature of TBE cases complicates efficacy trials, requiring large sample sizes or surrogate endpoints. Additionally, demonstrating long-term immunity and ensuring safety in diverse populations pose hurdles.

2. How might mRNA technology impact the future of TBE vaccines?
   mRNA platforms enable rapid development, scaling, and potential for improved efficacy and durability. They could also facilitate multivalent vaccines targeting multiple tick-borne viruses.

3. Are there any licensed universal or multivalent TBE vaccines in development?
   While current vaccines target TBE virus variants, research is ongoing into multivalent or universal flavivirus vaccines, which could provide broader protection against related pathogens.

4. What market factors could influence vaccine adoption in non-endemic regions?
   Increased travel, migration, and awareness campaigns can elevate demand. However, vaccine hesitancy and logistical barriers will influence uptake outside endemic zones.

5. How has COVID-19 influenced TBE vaccine development?
   The success of mRNA and viral vector platforms in COVID-19 accelerated research and innovation in TBE vaccine development, enabling faster transition from preclinical to clinical phases.

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References

[1] WHO. (2021). Tick-borne encephalitis. World Health Organization.
[2] Heinrich, N., et al. (2020). "Tick-borne encephalitis: vaccine efficacy and booster recommendations." Infect Dis.
[3] BioPlus LLC. (2022). “ATNV-017: Phase II Clinical Trial Results.” company announcement.
[4] MedVax Inc. (2022). “Preliminary Data on Vector-Based TBE Vaccine.” press release.
[5] Moderna. (2023). “Initiation of Phase I Trial for mRNA TBE Vaccine.” corporate update.
[6] MarketWatch. (2023). “Global TBE Vaccine Market Size and Forecast.”
[7] Kay, S. et al. (2021). "Climate change and expansion of tick habitats." Environ. Res.
[8] Johnson, N. et al. (2022). "Impact of COVID-19 on vaccine innovation." Vaccine Dev.