CLINICAL TRIALS PROFILE FOR TICOVAC

All Clinical Trials for TICOVAC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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 TICOVAC

Condition Name

Condition Name for TICOVAC
Intervention	Trials
Tick-Borne Encephalitis	1

Condition MeSH

Condition MeSH for TICOVAC
Intervention	Trials
Encephalitis, Tick-Borne	1
Encephalitis	1

Clinical Trial Locations for TICOVAC

Trials by Country

Trials by Country for TICOVAC
Location	Trials
United Kingdom	1

Clinical Trial Progress for TICOVAC

Clinical Trial Phase

Clinical Trial Phase for TICOVAC
Clinical Trial Phase	Trials
Phase 4	1

Clinical Trial Status

Clinical Trial Status for TICOVAC
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for TICOVAC

Sponsor Name

Sponsor Name for TICOVAC
Sponsor	Trials
University of Surrey	1

Sponsor Type

Sponsor Type for TICOVAC
Sponsor	Trials
Other	1

TICOVAC Market Analysis and Financial Projection

TICOVAC: Clinical Trials, Market Analysis, and Projections

Introduction to TICOVAC

TICOVAC, also known as Tick-Borne Encephalitis Vaccine (whole virus inactivated), is a vaccine developed by Pfizer Inc. to prevent tick-borne encephalitis (TBE), a serious and potentially life-threatening disease. Here, we will delve into the clinical trials, market analysis, and projections for this vaccine.

Clinical Trials and Safety

Immunogenicity and Efficacy

Clinical trials for TICOVAC were conducted to evaluate its immunogenicity and safety. These trials involved subjects of various age groups, from 1 to 65 years old. The vaccine was administered in a three-dose regimen, with the first two doses given one month apart and the third dose given six months after the first dose[1][3][4].

• Immunogenicity: The trials demonstrated high seropositivity rates, with 99.5% of children aged 1-15 years and 98.7-100% of adults showing neutralizing antibodies against the TBE virus after three doses[4].
• Vaccine Effectiveness: Real-world studies from Austria indicated that TICOVAC is 96-98.7% effective in individuals who received at least three doses[4].

Adverse Reactions

The clinical trials also assessed the safety profile of TICOVAC. Common adverse reactions included:

• Local Reactions: Local tenderness, local pain, and swelling were reported in both children and adults[3].
• Systemic Reactions: Fatigue, headache, muscle pain, and fever were among the systemic adverse reactions observed[3].

Serious adverse events (SAEs) and deaths were rare, with SAEs reported in 62 out of 3240 subjects in the pediatric group and one death reported, which was not vaccine-related[3].

FDA Approval and Regulatory History

Approval and Indication

TICOVAC was approved by the FDA on August 13, 2021, for active immunization to prevent TBE in individuals 1 year of age and older. This approval was significant as it marked the first FDA-approved vaccine for TBE, providing protection for US citizens traveling to or living in TBE-endemic areas[1][2][4].

Regulatory Context

The US Department of Defense (DOD) played a crucial role in requesting Pfizer to seek licensure for TICOVAC in the US, citing Public Law 115-92, which authorizes expedited development and review of medical products critical for military personnel[1].

Market Analysis

Market Size and Growth

The encephalitis vaccines market, which includes TICOVAC, is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.2% over the forecast period from 2024 to 2029. This growth is driven by increasing incidence of encephalitis, particularly in Asia-Pacific regions where Japanese encephalitis is prevalent[2].

Geographic Distribution

• North America: Currently holds the largest market share, with the US being a significant market due to the recent FDA approval of TICOVAC[2].
• Asia-Pacific: Expected to be the fastest-growing region, driven by the high incidence of Japanese encephalitis and other forms of encephalitis in countries such as Japan, India, and Australia[2].

Key Players

Pfizer Inc., along with other major players like Valneva SE, Bharat Biotech, and GlaxoSmithKline, dominates the encephalitis vaccines market. The market is characterized by low concentration, indicating a competitive landscape with multiple players[2].

Market Projections

Future Growth Drivers

• Increasing Incidence: The rising number of encephalitis cases, especially in Asia-Pacific, will drive the demand for vaccines like TICOVAC.
• Travel and Military Needs: The vaccine's approval for use in individuals traveling to or living in TBE-endemic areas, as well as its potential use by military personnel, will contribute to its market growth.
• Strategic Initiatives: Product launches, mergers, and acquisitions by key market players are expected to boost market growth[2].

Challenges

• Side Effects: While generally well-tolerated, the vaccine's side effects could be a constraint to market growth.
• Regulatory Hurdles: Variations in regulatory approvals and standards across different countries may pose challenges for widespread adoption[2].

Real-World Impact

Public Health Benefit

TICOVAC has been protecting millions of people in TBE-endemic regions for over 45 years since its first approval outside the US. Its FDA approval extends this protection to US citizens, reflecting Pfizer's commitment to global health[4].

Economic Impact

The approval and subsequent market growth of TICOVAC are expected to have a positive economic impact, particularly in regions with high TBE incidence. Reduced healthcare costs associated with treating TBE and the economic benefits of preventing long-term neurological damage will be significant[2].

Key Takeaways

• Clinical Trials: TICOVAC demonstrated high immunogenicity and efficacy in clinical trials across various age groups.
• FDA Approval: Approved for use in individuals 1 year of age and older, marking the first FDA-approved vaccine for TBE.
• Market Growth: The encephalitis vaccines market, including TICOVAC, is projected to grow at a CAGR of 5.2% from 2024 to 2029.
• Geographic Focus: North America currently holds the largest market share, while Asia-Pacific is expected to be the fastest-growing region.
• Challenges and Opportunities: Despite potential side effects and regulatory hurdles, the market is driven by increasing incidence of encephalitis and strategic initiatives by key players.

FAQs

What is TICOVAC, and what is it used for?

TICOVAC is a tick-borne encephalitis (TBE) vaccine used for active immunization to prevent TBE in individuals 1 year of age and older.

Who are the key players in the encephalitis vaccines market?

Key players include Pfizer Inc., Valneva SE, Bharat Biotech, and GlaxoSmithKline.

What is the projected growth rate of the encephalitis vaccines market?

The market is projected to grow at a CAGR of 5.2% from 2024 to 2029.

Which region is expected to grow the fastest in the encephalitis vaccines market?

The Asia-Pacific region is expected to grow the fastest due to the high incidence of Japanese encephalitis and other forms of encephalitis.

What are the common adverse reactions associated with TICOVAC?

Common adverse reactions include local tenderness, local pain, fatigue, headache, and muscle pain.

Sources

1. FDA: Summary Basis for Regulatory Action - TICOVAC, August 13, 2021.
2. Mordor Intelligence: Encephalitis Vaccines Market - Share, Size & Growth.
3. FDA: Package Insert - TICOVAC.
4. European Pharmaceutical Review: FDA approves TicoVac™ tick-borne encephalitis (TBE) vaccine.