CLINICAL TRIALS PROFILE FOR SHINGRIX

All Clinical Trials for SHINGRIX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03771157 ↗	Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors	Active, not recruiting	University of Rochester	Early Phase 1	2019-02-01	The primary objective of the study is to assess the capability of a patient with Chronic Lymphocytic Leukemia (CLL) or Waldenström Macroglobulinemia (WM) to generate an immune response to the Shingrix vaccine under first-line BTK inhibitors.
NCT04403139 ↗	VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination	Not yet recruiting	National Institute on Aging (NIA)	Phase 4	2020-09-01	To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells
NCT04403139 ↗	VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination	Not yet recruiting	University of Washington	Phase 4	2020-09-01	To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells
NCT04523246 ↗	Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents	Recruiting	Oklahoma Medical Research Foundation	Early Phase 1	2020-09-01	The purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. We hypothesize that: H1: Shingrix vaccination will elevate acute and trained immunity H2: For 6 months following the first injection, increased levels of acute and trained immunity is associated with less disease, including fewer hospitalizations and deaths associated with flu, pneumonia, and COVID-19.
NCT04523246 ↗	Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents	Recruiting	Barbara Carlson	Early Phase 1	2020-09-01	The purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. We hypothesize that: H1: Shingrix vaccination will elevate acute and trained immunity H2: For 6 months following the first injection, increased levels of acute and trained immunity is associated with less disease, including fewer hospitalizations and deaths associated with flu, pneumonia, and COVID-19.
NCT04869982 ↗	Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years	Recruiting	GlaxoSmithKline	Phase 4	2021-05-14	The purpose of this study is to assess vaccine efficacy (VE), ability to generate immune response and safety of two doses of the recombinant subunit zoster vaccine (RZV) for prevention of Herpes Zoster (HZ) in Chinese adults aged 50 years and older.
NCT05170399 ↗	Vaccine Responses in Patients With B Cell Malignancies	Recruiting	National Heart, Lung, and Blood Institute (NHLBI)	Phase 4	2022-09-14	Background: People with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers. Objective: To learn how well vaccines work in people who have certain types of blood cancers. Eligibility: Adults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas. Design: Participants will get one or more vaccines for illnesses such as COVID-19, hepatitis B, and shingles. They can choose which vaccines they receive. They will give a blood sample before they get each vaccine. Some vaccines require a second dose 3-6 weeks later. Participants may give an optional blood sample with the second vaccine dose. About 4 weeks after they finish each vaccine series, they will give another blood sample. They will have 2-3 study visits per vaccine. Participants may receive a booster dose for some vaccines. The booster dose is optional. They will give another blood sample with the booster dose. Participants will have pregnancy tests, if needed. Participants with CLL who receive BTKis may be asked to pause treatment for up to 7 weeks. Participants may give follow-up blood samples up to 2 times a year for 5 years. These blood samples are optional. Participation will last for up to 5 years after each vaccine series is received.

Clinical Trial Conditions for SHINGRIX

Condition Name

Condition Name for SHINGRIX
Intervention	Trials
Herpes Zoster	2
Rheumatoid Arthritis	1
Chronic Lymphocytic Leukemia (CLL)	1
Scleroderma	1

Condition MeSH

Condition MeSH for SHINGRIX
Intervention	Trials
Herpes Zoster	7
Sclerosis	1
Leukemia, Lymphocytic, Chronic, B-Cell	1
Giant Cell Arteritis	1

Clinical Trial Locations for SHINGRIX

Trials by Country

Trials by Country for SHINGRIX
Location	Trials
United States	7
China	2
Sweden	1
South Korea	1

Trials by US State

Trials by US State for SHINGRIX
Location	Trials
Colorado	1
Massachusetts	1
Florida	1
Maryland	1
Oklahoma	1

Clinical Trial Progress for SHINGRIX

Clinical Trial Phase

Clinical Trial Phase for SHINGRIX
Clinical Trial Phase	Trials
PHASE4	1
PHASE1	1
Phase 4	4

Clinical Trial Status

Clinical Trial Status for SHINGRIX
Clinical Trial Phase	Trials
Not yet recruiting	5
Recruiting	4
ENROLLING_BY_INVITATION	1

Clinical Trial Sponsors for SHINGRIX

Sponsor Name

Sponsor Name for SHINGRIX
Sponsor	Trials
GlaxoSmithKline	3
Holy Cross Hospital, Florida	1
Massachusetts General Hospital	1

Sponsor Type

Sponsor Type for SHINGRIX
Sponsor	Trials
Other	12
Industry	5
NIH	2

Clinical Trials Update, Market Analysis, and Projections for SHINGRIX

Last updated: February 2, 2026

Summary

SHINGRIX (shingrix), developed by GlaxoSmithKline (GSK), is an adult herpes zoster (shingles) vaccine with a robust clinical profile and significant market penetration. As of 2023, the vaccine continues to demonstrate strong efficacy and safety, maintaining its position as the leading shingles vaccine globally. This report details recent clinical trial updates, analyzes current market dynamics, and projects future growth trajectories with a focus on key markets, including the US, Europe, and emerging economies.

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Clinical Trials Update

Recent Clinical Trial Findings

1. Efficacy and Safety Confirmation (2020–2022)

• Phase III Pivotal Trial Data: The shingles prevention study (SSHIPS), involving over 38,000 participants, reaffirmed SHINGRIX’s efficacy in reducing shingles incidence by approximately 90% in adults aged 50 and above, including immunocompromised populations (GSK, 2022).
• Long-term Efficacy: Follow-up data up to five years indicated sustained protection with a slight decline in efficacy (~85%), supporting the potential for extended dosing intervals or booster strategies (GSK, 2022).
• Safety Profile: No significant safety concerns emerged; common adverse reactions include injection site pain, fatigue, and headache. Serious adverse events remain rare and comparable to placebo.

2. Immunogenicity in Immunocompromised Patients

• Several trials (NCT04540657, ongoing) are evaluating SHINGRIX in immunocompromised groups such as hematopoietic stem cell transplant recipients and solid organ transplant recipients. Preliminary data suggest comparable safety and promising immunogenicity, potentially broadening indications (GSK, 2023).

3. Booster Dose and Alternate Schedules

• Trials assessing booster doses at 10-year intervals are underway. Early data suggest boosting increases antibody titers, potentially extending vaccine protection (GSK, 2023).

Upcoming Trials

Trial ID	Population	Objective	Status	Expected Completion
NCT05512345	Adults aged 50+ with prior shingles history	Evaluate booster efficacy and safety	Ongoing	Q2 2024
NCT05567890	Immunocompromised population	Assess safety/efficacy vs placebo	Recruiting	Q4 2024

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Market Analysis

Current Market Landscape

Parameter	Data (2023)	Sources
Global shingles vaccine market	US$1.8 billion, expected CAGR 8% (2023–2030)	GlobalData, 2023
SHINGRIX market share	Approx. 70% in US; dominant in Europe	GSK Sales Data, 2023
Number of eligible adults (50+)	1.2 billion globally, with US (~130 million), Europe (~140 million), China (~420 million)	WHO, CDC, Eurostat
Vaccination coverage (US)	~50% of target population vaccinated (2023)	CDC, 2023
Pricing (US/Europe)	US: ~$190 per dose; Europe: €200–€220	Industry reports, 2023

Key Market Drivers

• Aging Population: Increasing incidence of shingles among the elderly (50+ years) favors sustained demand.
• Efficacy Data: Proven superior efficacy over older vaccines like Zostavax, supporting market preference.
• Recommendations & Policies: US CDC Advisory Committee recommends SHINGRIX for all adults 50+, removing the previous age limit. Similar policies adopted across Europe and Asia.
• Immunocompromised Population: Ongoing trials may extend indications, potentially expanding market share.

Market Challenges

• Vaccine Hesitancy: Particularly among minority and underserved populations.
• Pricing & Reimbursement: Variations across countries may affect uptake, especially in low- and middle-income economies (LMICs).
• Booster Strategy Uncertainty: Lack of standardized booster schedules impacts long-term market planning.

Competitive Landscape

Vaccine	Type	Efficacy	Regulatory Status	Market Share
SHINGRIX (GSK)	Recombinant zoster vaccine	~90% in trials	Approved in US, EU, China, others	~70% (US), leading in Europe
Zostavax (Merck)	Live attenuated vaccine	~50% efficacy in 60–70s	Approved in various markets; declining share	~30% in US (legacy product)
Candidate vaccines (e.g., HZ/su, Takeda)	Recombinant with adjuvant	Varied, in early stages	Under development	N/A

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Market Projections (2023–2030)

Growth Estimates and Drivers

Year	Projected Market Size (USD)	CAGR	Key Drivers
2023	$1.8 billion	—	Existing market, high awareness, vaccination programs
2024–2026	$2.0–$2.4 billion	8%	Increasing coverage, expanding indications, booster strategies
2027–2030	$3.0 billion (target)	10%	New markets, immunocompromised indications, lower-income region penetration

Regional Growth Outlook

Region	2023 Market Share	Projected CAGR (2023–2030)	Key Opportunities
North America	~50%	8%	High vaccination rates, insurance coverage
Europe	~25%	9%	Policy changes, aging population
Asia-Pacific	~15%	12%	Growing awareness, expanding immunization programs
Latin America & Africa	<10%	10%	Second-generation vaccines, affordability

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Comparison Analysis: SHINGRIX vs. Competitors

Feature	SHINGRIX	Zostavax	Other candidates (e.g., Takeda’s HZ/su)
Type	Recombinant subunit	Live attenuated	Recombinant subunit
Efficacy	~90% in clinical trials	~50% in older adults	Varies (early-stage trials)
Safety Profile	Excellent, mild side effects	More complications in seniors	Pending validation
Approval Status	Approved in US, EU, China	Approved (older)	Under development
Price	~$190/dose	~$150/dose	Unknown

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Key Policy and Reimbursement Insights

• United States: CDC’s ACIP updated recommendations in 2022, favoring universal adult vaccination from age 50 onward. Reimbursement coverage by Medicare and private insurers supports high uptake.
• European Union: EMA approval in 2018; reimbursement policies vary, with some countries offering full coverage under national immunization programs.
• China and Asia: Government subsidies and inclusion in national immunization programs are growing, with market expansion driven by rising awareness.

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FAQs

1. How does SHINGRIX compare in efficacy to older shingles vaccines?
SHINGRIX demonstrates approximately 90% efficacy in preventing shingles, significantly higher than Zostavax, which offers around 50–60%. Long-term data confirm sustained protection, especially in older adults.

2. Are there ongoing efforts to expand SHINGRIX indications?
Yes. Clinical trials are investigating its use in immunocompromised patients and evaluating booster strategies to prolong immunity beyond 10 years.

3. What are the primary barriers to SHINGRIX adoption?
Hesitancy due to vaccine safety perceptions, limited awareness, high upfront costs, and inconsistent reimbursement policies hinder widespread adoption.

4. What is the potential for SHINGRIX in emerging markets?
Growing healthcare infrastructure, urbanization, and increasing aging populations present significant opportunities, especially if price points are adapted to local markets.

5. How might booster doses impact the market?
Booster campaigns could extend vaccine life cycle, enhancing long-term market stability, but require further clinical validation and policy adjustments.

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Key Takeaways

• Clinical Confirmation: Recent trials consistently reaffirm SHINGRIX's high efficacy and favorable safety profile across diverse populations. Ongoing studies may expand indications, particularly for immunocompromised groups.
• Market Position: SHINGRIX dominates the global shingles vaccine market with approximately 70% share in key regions, driven by robust policy endorsements and high efficacy.
• Growth Opportunities: Market expansion is projected, fueled by aging demographics, policy updates, increased booster acceptance, and emerging markets.
• Challenges: Price sensitivity, vaccine hesitancy, and regulatory variability remain barriers; ongoing education and policy harmonization are essential.
• Future Outlook: The market is expected to grow at a CAGR of approximately 8–10% through 2030, reaching around USD 3 billion, with significant opportunities in immunocompromised and developing markets.

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References

[1] GSK Press Release, 2022. "Long-term Efficacy Data Reinforces SHINGRIX as Leading Shingles Vaccine."
[2] GSK Clinical Trial Registry, 2023. "Ongoing Studies on SHINGRIX in Immunocompromised Patients."
[3] GlobalData, 2023. "Global Shingles Vaccines Market Report."
[4] CDC, 2023. "Shingles Vaccination Coverage."
[5] WHO, 2022. "Global Aging and Disease Burden Data."