CLINICAL TRIALS PROFILE FOR ZOSTER VACCINE RECOMBINANT, ADJUVANTED

All Clinical Trials for zoster vaccine recombinant, adjuvanted

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.
NCT05775718 ↗	Shingrix In Recipients of Allogeneic Transplants	Not yet recruiting	GlaxoSmithKline	Phase 2	2023-12-01	This research is designed to determine if the adjuvanted recombinant glycoprotein E (gE) herpes zoster (HZ) vaccine (Shingrix) has acceptable immunogenicity and safety in people who have undergone allogeneic stem cell transplant (allo-SCT). Specifically, it will determine the effect of the interval after transplantation on the immune response and if an additional dose of vaccine is needed to improve the vaccine-induced responses.
NCT05775718 ↗	Shingrix In Recipients of Allogeneic Transplants	Not yet recruiting	University of Colorado, Denver	Phase 2	2023-12-01	This research is designed to determine if the adjuvanted recombinant glycoprotein E (gE) herpes zoster (HZ) vaccine (Shingrix) has acceptable immunogenicity and safety in people who have undergone allogeneic stem cell transplant (allo-SCT). Specifically, it will determine the effect of the interval after transplantation on the immune response and if an additional dose of vaccine is needed to improve the vaccine-induced responses.

Clinical Trial Conditions for zoster vaccine recombinant, adjuvanted

Condition Name

Condition Name for zoster vaccine recombinant, adjuvanted
Intervention	Trials
Stem Cell Transplant	1
Waldenstrom Macroglobulinemia (WM)	1
Bone Marrow Transplant	1
Chronic Lymphocytic Leukemia (CLL)	1

Condition MeSH

Condition MeSH for zoster vaccine recombinant, adjuvanted
Intervention	Trials
Leukemia	1
Herpes Zoster	1
Waldenstrom Macroglobulinemia	1
Leukemia, Lymphoid	1

Clinical Trial Locations for zoster vaccine recombinant, adjuvanted

Trials by Country

Trials by Country for zoster vaccine recombinant, adjuvanted
Location	Trials
United States	2

Trials by US State

Trials by US State for zoster vaccine recombinant, adjuvanted
Location	Trials
Colorado	1
New York	1

Clinical Trial Progress for zoster vaccine recombinant, adjuvanted

Clinical Trial Phase

Clinical Trial Phase for zoster vaccine recombinant, adjuvanted
Clinical Trial Phase	Trials
Phase 2	1
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for zoster vaccine recombinant, adjuvanted
Clinical Trial Phase	Trials
Not yet recruiting	1
Active, not recruiting	1

Clinical Trial Sponsors for zoster vaccine recombinant, adjuvanted

Sponsor Name

Sponsor Name for zoster vaccine recombinant, adjuvanted
Sponsor	Trials
University of Rochester	1
GlaxoSmithKline	1
University of Colorado, Denver	1

Sponsor Type

Sponsor Type for zoster vaccine recombinant, adjuvanted
Sponsor	Trials
Other	2
Industry	1

Zoster Vaccine Recombinant, Adjuvanted: Clinical Trials Update, Market Analysis, and Projections

Last updated: March 9, 2026

What is the current status of clinical trials for the recombinant, adjuvanted shingles vaccine?

The recombinant, adjuvanted zoster vaccine, commercially known as Shingrix, is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as of 2017 and 2018, respectively. It is indicated for the prevention of herpes zoster and postherpetic neuralgia in adults aged 50 and older.

Key Clinical Trials:

• Pivotal trials (ZOE-50 and ZOE-70) included over 38,000 participants.
• Efficacy: 97.2% in adults aged 50-59, and 91.3% in those aged 70-79.
• Duration of protection: At least 4 years with significant immune response sustained.
• Safety: Mainly local and mild systemic adverse reactions; rare cases of Guillain-Barré syndrome reported.

Ongoing Studies:

• Extended follow-up to assess long-term efficacy.
• Phase 4 post-marketing surveillance evaluating rare adverse events.
• Trials assessing booster doses in immunocompromised populations.

How does the market for zoster vaccines look currently?

The global herpes zoster vaccine market was valued at approximately USD 850 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 12% through 2030.

Market Drivers:

• Aging population: Forecasted to reach 1.5 billion individuals aged 60+ by 2030.
• Increasing awareness: Physicians recommend vaccination for older adults.
• Product dominance: Shingrix holds over 90% market share in the U.S.

Geographical Distribution:

Region	Market Share (2022)	Growth Factors
North America	65%	High vaccination rates, supportive policies
Europe	20%	Growing awareness, expanding approval
Asia-Pacific	10%	Emerging markets, rising healthcare spending
Rest of World	5%	Limited access, nascent immunization programs

Competitive Landscape:

• Only marketed product: Shingrix (GSK).
• Upcoming competitors: Live attenuated vaccine (Zostavax, discontinued in some markets).
• R&D pipeline: Limited; focus remains on booster doses and formulations for immunocompromised.

What are the projections for market growth and future adoption?

The market is expected to reach USD 1.75 billion by 2030, reflecting steady growth driven by demographic trends and vaccination policies.

Factors Influencing Growth:

• New approvals in countries with low current coverage.
• Expansion of indications: Potential for use in immunocompromised populations.
• Pricing: Premium pricing for newer formulations; affordability impacts adoption.

Barriers to Market Expansion:

• Cost: Higher price point compared to live vaccines (USD 150-200 per dose).
• Vaccine acceptance: Vaccine hesitancy among older populations.
• Supply chain logistics: Cold chain requirements complicate distribution.

Potential Market Share Opportunities:

• Immunocompromised adults not adequately protected by live vaccines.
• Booster doses for sustaining immunity in aging populations.

Summary of key data points

Aspect	Details
Clinical trial efficacy	91.3-97.2% in preventing herpes zoster
FDA approval year	2017
EMA approval year	2018
Market size (2022)	USD 850 million
Projected market size (2030)	USD 1.75 billion
CAGR (2023–2030)	12%

Key Takeaways

• The recombinant, adjuvanted zoster vaccine is well-established, with pivotal trials confirming high efficacy.
• Market growth is robust, driven by aging demographics and policy shifts promoting vaccination.
• Limited competitors and ongoing research retain Shingrix's market dominance.
• Price and logistical barriers could delay broader adoption, especially in emerging markets.
• Expansion into immunocompromised populations presents future growth avenues.

FAQs

1. Is the vaccine effective in immunocompromised individuals?
The vaccine is authorized for immunocompromised adults over 18, with studies indicating comparable efficacy in such populations.

2. How long does immunity last after vaccination?
Data up to 4 years shows sustained immune response; longer-term efficacy ongoing to be determined.

3. What are the main safety concerns?
Generally well tolerated. Rare adverse events include Guillain-Barré syndrome; serious reactions are infrequent.

4. Will the vaccine be recommended for younger adults?
Current approvals focus on adults aged 50 and older, as efficacy in younger groups has not been established.

5. Are there plans to develop a live attenuated variant?
Most development focuses on booster formulations and formulations suitable for immunocompromised populations, rather than live vaccines.

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References

[1] GlaxoSmithKline. (2022). Shingrix product information.
[2] U.S. Food and Drug Administration. (2017). Herpes zoster vaccine (Shingrix) approval notices.
[3] European Medicines Agency. (2018). Summary of product characteristics for Shingrix.
[4] Market Research Future. (2023). Herpes zoster vaccine market analysis.