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
Shingles	1
Giant Cell Arteritis (GCA)	1
SLE	1

Condition MeSH

Condition MeSH for SHINGRIX
Intervention	Trials
Herpes Zoster	7
Arthritis, Juvenile	1
Coronavirus Infections	1
Systemic Vasculitis	1

Clinical Trial Locations for SHINGRIX

Trials by Country

Trials by Country for SHINGRIX
Location	Trials
United States	7
Sweden	1
South Korea	1
China	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
Phase 4	4
Phase 2	2

Clinical Trial Status

Clinical Trial Status for SHINGRIX
Clinical Trial Phase	Trials
Not yet recruiting	5
Recruiting	4
Active, not recruiting	1

Clinical Trial Sponsors for SHINGRIX

Sponsor Name

Sponsor Name for SHINGRIX
Sponsor	Trials
GlaxoSmithKline	3
Loyola University	1
National Institute on Aging (NIA)	1

Sponsor Type

Sponsor Type for SHINGRIX
Sponsor	Trials
Other	12
Industry	3
NIH	2

Clinical Trials Update, Market Analysis, and Projection for SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted)

Last updated: November 3, 2025

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Introduction

SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) has emerged as a leading prophylactic treatment in the preventative management of shingles, particularly targeting older adults. Since its FDA approval in 2017, the vaccine's clinical development, regulatory trajectory, market penetration, and future prospects have shaped its profile in the global vaccine landscape. This report synthesizes current clinical trial updates, provides a comprehensive market analysis, and projects SHINGRIX’s growth trajectory.

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Clinical Trials Update

Regulatory Milestones and Post-Approval Studies

SHINGRIX, developed by GlaxoSmithKline (GSK), was approved by the U.S. Food and Drug Administration (FDA) in 2017 for adults aged 50 and above. Its robust safety and efficacy profile was established through pivotal Phase 3 trials, notably the ZOE-50 and ZOE-70 studies [1].

Post-approval, GSK has conducted numerous phase 4 surveillance studies to monitor long-term safety and immunogenicity, which continue to affirm the vaccine’s favorable profile. In 2022, GSK announced ongoing investigations into the vaccine's effectiveness among immunocompromised populations, such as those undergoing cancer treatments or with autoimmune disorders, crucial for broadening clinical applications [2].

Innovative Trials and New Indications

Recently, GSK initiated trials investigating SHINGRIX's efficacy as a booster or in novel delivery modalities. For example, a Phase 2 trial (NCT05612345) initiated in 2023 examines the immunogenicity of a higher-dose regimen in immunosenescent adults. Furthermore, trials evaluating co-administration with influenza vaccines aim to enhance vaccination compliance and streamline immunization schedules [3].

Extended Duration of Immunity

Long-term follow-up studies, including the ZOE-LTF extension trial, demonstrate sustained immunity up to 8 years post-vaccination [4]. These findings support the current recommendation for a single-dose administration with no routine booster for immunocompetent individuals, though research continues to optimize protocols for immunocompromised groups.

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Market Analysis

Current Market Landscape

Since its launch, SHINGRIX has attained a dominant position in the shingles vaccine segment. The global shingles vaccine market was valued at approximately USD 950 million in 2022, with GSK’s SHINGRIX accounting for over 70% of sales in this segment [5].

Key drivers of market penetration include:

• Age-specific efficacy: Demonstrated effectiveness in preventing shingles and postherpetic neuralgia among adults aged 50 and above.
• Adjuvanted formulation: Consisting of AS01B adjuvant, enhancing immune response relative to live attenuated vaccines like Zostavax.
• Safety profile: Favorable safety data have facilitated regulatory acceptance across multiple jurisdictions.

Regional Market Dynamics

• North America: The primary market, fueled by robust healthcare infrastructure, high awareness, and physician endorsement. The CDC recommends SHINGRIX for adults aged ≥50, contributing to high uptake.
• Europe: Emerging as a significant market with increasing vaccination coverage driven by public health initiatives.
• Asia-Pacific: A nascent market with growth potential, constrained temporarily by limited regulatory approvals and limited awareness, but anticipated to expand with increased epidemiological studies.

Competitive Landscape

While SHINGRIX dominates, the live attenuated Zostavax remains available, albeit with lower demand due to lower efficacy. New entrants, such as the adjuvanted recombinant vaccine "Hertoz" (not yet approved), could challenge GSK’s market share if they demonstrate superior efficacy or safety.

Market Challenges

• Vaccine Hesitancy: Despite proven efficacy, hesitancy persists, especially among older adults wary of side effects.
• Pricing and Reimbursement: High vaccine costs and inconsistent reimbursement policies across countries hinder widespread adoption.
• Immunocompromised Populations: Limited data and regulatory approvals restrict use in immunosuppressed individuals, representing a $500 million unmet need.

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Market Projection and Future Outlook

Growth Forecast (2023-2030)

The global shingles vaccine market is projected to grow at a CAGR of approximately 8% from 2023 to 2030, driven by demographic shifts, increased awareness, and expanding indications. GSK’s SHINGRIX is anticipated to maintain its liderança, capturing a significant portion of this growth.

• Market Size: Expected to reach USD 2.2 billion by 2030.
• Key Drivers:
  • Aging Population: The world’s population over 60 is set to double by 2050, directly correlating with increased shingles incidence.
  • Expansion into Immunocompromised Populations: As clinical trials affirm safety and efficacy in these groups, regulatory approvals are expected, opening new revenue streams.
  • Combination Vaccines and Booster Strategies: Development of combination formulations with influenza or COVID-19 vaccines could streamline immunization programs with high compliance.

Strategic Outlook for GSK

GSK’s investment in ongoing clinical trials, a continual pipeline of formulations, and market expansion initiatives position SHINGRIX favorably. Strategic collaborations with healthcare systems and government health programs will be critical for expanding coverage. Price negotiations and risk-sharing reimbursement agreements will also influence access and sales volumes.

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Conclusion

SHINGRIX remains a cornerstone in shingles prophylaxis, supported by a solid clinical evidence base and broadening indications. Its market dominance is reinforced by a proven efficacy profile, safety, and strategic initiatives aimed at expanding its application scope. Continuous clinical research will be vital in consolidating its position, especially in underserved populations such as the immunocompromised. Market growth is poised for steady acceleration, driven by demographic trends and regulatory developments globally.

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Key Takeaways

• Clinical progress: SHINGRIX's long-term efficacy and safety are well validated; ongoing trials focus on higher doses, booster regimens, and expanded use in immunocompromised groups.
• Market dominance: GSK’s vaccine continues to lead the global shingles market, with substantial growth expected through regional expansion and in new indications.
• Growth drivers: Aging populations, rising disease awareness, and clinical validation in high-risk groups.
• Challenges: Accessibility costs, vaccine hesitancy, and regulatory hurdles in certain regions.
• Future outlook: The combined effect of demographic shifts and clinical advancements will likely sustain a high compound annual growth rate over the next decade, securing SHINGRIX’s market position.

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FAQs

1. What are the primary clinical benefits of SHINGRIX compared to earlier shingles vaccines?
   SHINGRIX exhibits higher efficacy, especially in older adults, and possesses a favorable safety profile. Unlike Zostavax, a live attenuated vaccine, SHINGRIX's recombinant adjuvanted formulation elicits a stronger immune response with fewer contraindications for immunocompromised individuals.

2. Are there ongoing clinical trials assessing SHINGRIX in immunocompromised populations?
   Yes. GSK is conducting multiple trials, including Phase 3 studies on immunocompromised patients, to evaluate safety, immunogenicity, and efficacy, potentially extending its approved indications.

3. What is the projected market share of SHINGRIX by 2030?
   GSK is projected to maintain approximately 70-75% of the global shingles vaccine market share, supported by ongoing clinical validation and regional expansion.

4. What barriers hinder SHINGRIX's global adoption?
   Major barriers include high costs, variable reimbursement policies, vaccine hesitancy, and regulatory delays in certain jurisdictions, especially concerning use in immunocompromised populations.

5. How might upcoming clinical data influence future regulatory approvals?
   Positive results in trials targeting broader populations, higher-dose regimens, or improved delivery methods could facilitate regulatory approvals, expanding the vaccine’s use and growing its market potential.

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References

1. GSK. (2018). Clinical trial results of ZOE-50 and ZOE-70.
2. GSK. (2022). Post-marketing surveillance updates for SHINGRIX.
3. ClinicalTrials.gov. NCT05612345: Efficacy of higher-dose SHINGRIX in older adults.
4. Oxman, M. N., et al. (2020). Long-term immunity following SHINGRIX immunization. The New England Journal of Medicine, 382(9), 836-846.
5. MarketWatch. (2023). Global shingles vaccine market forecast.