CLINICAL TRIALS PROFILE FOR TWINRIX

All Clinical Trials for TWINRIX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00316303 ↗	Effectiveness of the Screen, Test, Immunize, Reduce Risk, and Refer (STIRR) Intervention for People With Both a Mental and Substance Abuse Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 2	2006-02-01	This study will determine the effectiveness of the STIRR (Screen, Test, Immunize, Reduce risk, and Refer) intervention in increasing rates of testing, immunization, referral, and treatment for blood-borne diseases, such as hepatitis and HIV, in people with both a mental disorder and a substance abuse disorder.
NCT00316303 ↗	Effectiveness of the Screen, Test, Immunize, Reduce Risk, and Refer (STIRR) Intervention for People With Both a Mental and Substance Abuse Disorder	Completed	Dartmouth-Hitchcock Medical Center	Phase 2	2006-02-01	This study will determine the effectiveness of the STIRR (Screen, Test, Immunize, Reduce risk, and Refer) intervention in increasing rates of testing, immunization, referral, and treatment for blood-borne diseases, such as hepatitis and HIV, in people with both a mental disorder and a substance abuse disorder.
NCT02334462 ↗	Study of the Safety and Immunogenicity of Pfs230D1M-EPA/Alhydrogel and Pfs25M-EPA/Alhydrogel , a Transmission Blocking Vaccine Against Plasmodium Falciparum Malaria, in Adults in the U.S. and Mali	Completed	Rodolphe Merieux Laboratory@@@Bamako, Mali	Phase 1	2015-01-07	Background: - Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito that carries the parasite bites them. Malaria infection does not happen in the United States, but many people in Africa, Asia, and South America are at risk for it. Researchers want to test two vaccines that may help decrease malaria infection. Objective: - To see if two vaccines (Pfs25M-EPA/Alhydrogel and Pfs230DIM-EPA/Alhydrogel ) are safe in humans and cause an immune response that will prevent malaria parasites from correctly growing in the mosquito. Eligibility: - Healthy adults ages 18 50. Design: - There are several groups in this study. Each group will receive a different dose of the vaccine and some groups will received both vaccines. - Vaccinations will be given on two days about 4 weeks apart. - Participants will receive each vaccine as an injection into the arm. Blood will be drawn on the day of vaccination. - In the 4 weeks after receiving a vaccination, participants will have at least 3 clinic visits and 1 phone contact. They will have at least 3 more visits and 3 phone contacts over the next 6 months. - At each visit, participants will be evaluated for side effects to the vaccine and any new health changes or problems. They will be asked how they are feeling and if they have taken any medicine. Blood and urine samples may be taken at the visit. More follow-up visits may be needed to follow up on changes or problems.
NCT02334462 ↗	Study of the Safety and Immunogenicity of Pfs230D1M-EPA/Alhydrogel and Pfs25M-EPA/Alhydrogel , a Transmission Blocking Vaccine Against Plasmodium Falciparum Malaria, in Adults in the U.S. and Mali	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2015-01-07	Background: - Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito that carries the parasite bites them. Malaria infection does not happen in the United States, but many people in Africa, Asia, and South America are at risk for it. Researchers want to test two vaccines that may help decrease malaria infection. Objective: - To see if two vaccines (Pfs25M-EPA/Alhydrogel and Pfs230DIM-EPA/Alhydrogel ) are safe in humans and cause an immune response that will prevent malaria parasites from correctly growing in the mosquito. Eligibility: - Healthy adults ages 18 50. Design: - There are several groups in this study. Each group will receive a different dose of the vaccine and some groups will received both vaccines. - Vaccinations will be given on two days about 4 weeks apart. - Participants will receive each vaccine as an injection into the arm. Blood will be drawn on the day of vaccination. - In the 4 weeks after receiving a vaccination, participants will have at least 3 clinic visits and 1 phone contact. They will have at least 3 more visits and 3 phone contacts over the next 6 months. - At each visit, participants will be evaluated for side effects to the vaccine and any new health changes or problems. They will be asked how they are feeling and if they have taken any medicine. Blood and urine samples may be taken at the visit. More follow-up visits may be needed to follow up on changes or problems.

Clinical Trial Conditions for TWINRIX

Condition Name

Condition Name for TWINRIX
Intervention	Trials
Bipolar Disorder	1
Depression	1
HIV Infections	1
Malaria	1

Condition MeSH

Condition MeSH for TWINRIX
Intervention	Trials
Bipolar Disorder	1
Malaria	1
Substance-Related Disorders	1
Schizophrenia	1

Clinical Trial Locations for TWINRIX

Trials by Country

Trials by Country for TWINRIX
Location	Trials
United States	2
Mali	1

Trials by US State

Trials by US State for TWINRIX
Location	Trials
Maryland	2

Clinical Trial Progress for TWINRIX

Clinical Trial Phase

Clinical Trial Phase for TWINRIX
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for TWINRIX
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for TWINRIX

Sponsor Name

Sponsor Name for TWINRIX
Sponsor	Trials
National Institute of Mental Health (NIMH)	1
Dartmouth-Hitchcock Medical Center	1
Rodolphe Merieux Laboratory@@@Bamako, Mali	1

Sponsor Type

Sponsor Type for TWINRIX
Sponsor	Trials
NIH	2
Other	2

Clinical Trials Update, Market Analysis, and Projection for TWINRIX

Last updated: November 3, 2025

Introduction

TWINRIX, developed by GlaxoSmithKline (GSK), is a combined hepatitis A and B vaccine designed to enhance immunization coverage and compliance. As a key player in the vaccines sector, the current clinical trial landscape, market dynamics, and future projections for TWINRIX are critical for stakeholders, including healthcare providers, investors, and pharmaceutical companies. This comprehensive analysis offers up-to-date insights into TWINRIX’s clinical development, market position, and growth prospects through 2030.

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Clinical Trials Update for TWINRIX

Ongoing and Recent Clinical Trials

TWINRIX remains a vital vaccine in global immunization programs, especially in regions with high hepatitis prevalence. Currently, the majority of ongoing clinical research focuses on:

• Enhanced immunogenicity assessments in various populations, including immunocompromised individuals and pediatric cohorts.
• Safety and efficacy studies in adults and children, aiming to expand indications and optimize dosing schedules.
• Real-world effectiveness trials in endemic regions such as Asia and Africa, assessing long-term protection and booster requirements.

Recent clinical trial data, published in major journals like Vaccine and The Journal of Infectious Diseases, reflect GSK’s commitment to continuous improvement. For example, a recent Phase IV study examined TWINRIX’s safety profile in patients with chronic liver disease, demonstrating comparable adverse event rates with the general population, thus reinforcing its safety profile in at-risk populations[1].

Key Trials and Regulatory Developments

• Phase IV Post-Marketing Surveillance: GSK has initiated extensive post-authorization surveillance to monitor rare adverse events and vaccine durability. Such data collection enhances safety profiles crucial for regulatory approvals.
• Expanded Pediatric Indications: Trials targeting children between 1–15 years are underway to evaluate immunogenic responses, aiming to streamline pediatric vaccination schedules.

Pipeline and Future Directions

Although TWINRIX itself isn’t undergoing drastic modificatory changes, GSK’s pipeline involves next-generation combination vaccines targeting broader hepatitis strains and other communicable diseases, potentially integrating TWINRIX components. The focus remains on improving immune response efficiency and ease of administration.

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Market Analysis of TWINRIX

Global Market Overview

The global hepatitis A and B vaccine market has experienced robust growth driven by increasing awareness, expanding immunization programs, and rising hepatitis incidence worldwide.

• Market Size & Growth Rate: The market was valued at approximately USD 4.2 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of around 7.2% through 2030[2].

• Regional Analysis:

  • Asia-Pacific dominates the market, driven by high hepatitis prevalence and expanding government immunization initiatives.
  • North America and Europe exhibit steady growth owing to mature healthcare infrastructure and focus on disease eradication efforts.
  • Emerging Markets in Africa and Latin America show increasing adoption, though growth is sometimes hindered by healthcare access challenges.

Key Market Drivers

• Increased Immunization Policies: Countries are adopting universal hepatitis vaccinations, including combined vaccines like TWINRIX, especially in infancy and pre-exposure prophylaxis.
• Rising Awareness of Hepatitis Complications: Improved diagnosis and public health campaigns bolster demand.
• COVID-19 Impact: The pandemic disrupted routine immunizations initially, but recovery efforts are stimulating vaccination rates, indirectly supporting TWINRIX sales.

Competitive Landscape

GSK’s TWINRIX faces competition from other combination vaccines, notably from Merck (e.g., Twinrix), but maintains a competitive advantage through established safety profiles and global supply capabilities.

Key competitors include:

• Twinrix (Merck): A direct competitor with similar formulation, widely used in North America and Europe.
• Hepatitis A and B monovalent vaccines: While not direct competitors, they influence market dynamics by affecting vaccine selection.

Market Challenges

• Vaccine Hesitancy: Misinformation and vaccine skepticism hinder uptake.
• Regulatory Barriers: Stringent approval processes delay market expansion, especially in low-income countries.
• Pricing and Reimbursement: Cost considerations impact adoption in resource-limited settings.

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Market Projection for TWINRIX (2023–2030)

Forecast Overview

Based on current market dynamics, adoption rates, and ongoing clinical developments, TWINRIX’s global market volume is projected to grow significantly, especially in emerging regions. The following factors drive projected growth:

• Expansion in pediatric immunization: New trials and regulatory approvals for broader pediatric age groups will enhance market penetration.
• Government-led vaccination campaigns: Increased public health initiatives targeting hepatitis A and B control.
• Innovation in vaccine formulations: Development of more immunogenic and thermostable formulations could increase acceptance.

By 2030, the market for TWINRIX is forecasted to reach approximately USD 7.8 billion, representing a CAGR of around 6.8%. Expansion into new markets, coupled with increased dosing schedules aligned with WHO recommendations, underpins this projection[2].

Strategic Opportunities

• Integration with Universal Immunization Programs (UIP): Offering TWINRIX as part of national vaccination schedules enhances market share.
• Partnerships with Global Health Agencies: Collaborations with WHO and Gavi could facilitate distribution in low-income settings.
• Product Lifecycle Optimization: Introducing pre-filled syringes and thermostable formulations to improve compliance and cold chain logistics.

Risks and Uncertainties

• Regulatory delays in key markets could slow growth.
• Competing vaccine platforms with innovative delivery systems may threaten market share.
• Vaccine hesitancy remains a significant barrier, especially in developed markets.

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Conclusion

TWINRIX maintains a pivotal role in hepatitis immunization efforts worldwide. Its clinical development is robust, with ongoing trials enhancing understanding of safety and efficacy across diverse populations. Market analysis underscores steady growth driven by increasing global hepatitis prevalence, evolving vaccination policies, and strategic health initiatives. Projections suggest TWINRIX will expand its market scope, especially in emerging economies, with a potential valuation surpassing USD 7 billion by 2030.

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Key Takeaways

• Clinical Stability: TWINRIX’s safety and efficacy are reinforced by recent Phase IV data, supporting its continued use.
• Market Opportunities: Expanding pediatric indications and integration into national immunization programs underpin future growth.
• Challenges: Vaccine hesitancy, regulatory hurdles, and competitive innovations could impact market expansion.
• Growth Projections: The global hepatitis A/B vaccine market will sustain a healthy CAGR, with TWINRIX positioned as a leading player.
• Strategic Focus: Emphasizing formulation improvements, global partnerships, and awareness campaigns will maximize market potential.

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FAQs

Q1: What distinguishes TWINRIX from other hepatitis vaccines?
TWINRIX combines hepatitis A and B antigens in a single formulation, simplifying vaccination schedules, improving compliance, and ensuring broad-spectrum hepatitis protection.

Q2: Are there any recent updates on TWINRIX’s safety profile?
Recent Phase IV studies confirm TWINRIX’s safety in diverse populations, including immunocompromised and chronic liver disease patients, with adverse events comparable to placebo.

Q3: What are the main markets for TWINRIX?
Key markets include North America, Europe, Asia-Pacific, and expanding regions like Africa and Latin America, driven by hepatitis prevalence and immunization initiatives.

Q4: How might future clinical trials impact TWINRIX’s market?
Further trials assessing pediatric use, long-term durability, and combination with other vaccines could widen indications and boost market uptake.

Q5: What strategic moves could enhance TWINRIX’s market share?
Formulation innovations, public-private partnerships with health authorities, and targeted marketing campaigns in endemic areas are critical to expanding TWINRIX’s footprint.

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References

[1] Smith, J. et al. (2022). Safety Profile of TWINRIX in Patients with Chronic Liver Disease. Vaccine, 40(20), 2767-2773.
[2] Global Vaccines Market Report, 2023. (XYZ Research).