CLINICAL TRIALS PROFILE FOR ZOSTER VACCINE LIVE

All Clinical Trials for zoster vaccine live

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01474720 ↗	Zostavax in Systemic Lupus Erythematosus	Completed	Oklahoma Medical Research Foundation	Phase 1	2011-11-01	Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk for the development of shingles, a painful reactivation of the varicella zoster virus that causes chicken pox. The investigators propose to study the immune response to commercially available Zostavax vaccine (shingles vaccine) in adult patients with SLE who have minimal disease activity and are on mild immunosuppressant medications, and to compare the immune response to that seen in healthy people following vaccination. Acceptable immunosuppressive drugs permitted in the study are those felt to be safe according to Centers for Disease Control guidelines. Ten healthy people and 10 SLE patients (all over 50 years of age) will be recruited to receive a single, standard dose of Zostavax. Blood samples and physical examination will be performed prior to injection, then 2,6,and 12 weeks following vaccination. All participants will receive active vaccine, there is no placebo group.
NCT01506661 ↗	Safety of Zostavax Vaccination in Rheumatoid Arthritis	Completed	Oklahoma Medical Research Foundation	Phase 1	2012-01-01	Herpes Zoster (shingles) is caused by reactivation of latent varicella zoster virus (VZV) that usually occurs decades following initial exposure. The risk of developing shingles increases with age. Shingles presents as a painful, itchy blistering rash that usually involves a single portion of the skin and lasts about 7-10 days. The risk of developing shingles increases with age in healthy people, and has been shown in some studies to be increased in people with rheumatoid arthritis and other autoimmune diseases. Zostavax, a live-attenuated vaccine against the varicella zoster virus, was first approved by the FDA for the prevention of Shingles among people 60 years and older, and is now approved for use in people aged 50 years and older. Because rheumatoid arthritis and some of the medications used to treat rheumatoid arthritis can impair the body's immune system, it is not known how much of an immune response can be generated in people with rheumatoid arthritis. The goals of this study are to measure the immune response after standard vaccination with Zostavax in people with rheumatoid arthritis in comparison to people with healthy immune systems. All participants will be 50 years old or older, and subjects with rheumatoid arthritis will not be eligible if they are taking certain biologic medications, including TNF inhibitors (Etanercept or Adalimumab). Ten healthy subjects and 10 subjects with rheumatoid arthritis will all receive a single vaccination with Zostavax, then will be followed for 12 weeks to assess the immune response and for the development of local rash or other potential side effects.
NCT01623596 ↗	Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.	Completed	Novartis Pharmaceuticals	Phase 4	2012-06-08	A 12 month study where 852 patients with relapsing remitting MS will be randomized 1:1 to fingolimod or approved disease modifying therapy. Patients will be be treatment naive or have only been treated with one class of DMT (Interferon beta preparation or glatiramer acetate) . Patients will be able to switch to different treatment for safety, efficacy, tolerability or convenience during the study. Primary objective is to evaluate efficacy of fingolimod by assessing patients retention on treatment. Secondary objectives are to compare reasons for discontinuation, adverse events, cognitive impairment, medication satisfaction and change in brain volume measured by MRI.

Clinical Trial Conditions for zoster vaccine live

Condition Name

Condition Name for zoster vaccine live
Intervention	Trials
Herpes Zoster	7
Rheumatoid Arthritis	5
Psoriasis	3

Condition MeSH

Condition MeSH for zoster vaccine live
Intervention	Trials
Herpes Zoster	14
Arthritis	6
Arthritis, Rheumatoid	5

Clinical Trial Locations for zoster vaccine live

Trials by Country

Trials by Country for zoster vaccine live
Location	Trials
United States	138
United Kingdom	15
Canada	14
Mexico	12
Australia	8

Trials by US State

Trials by US State for zoster vaccine live
Location	Trials
New York	8
Florida	7
California	6
Washington	6
Texas	6

Clinical Trial Progress for zoster vaccine live

Clinical Trial Phase

Clinical Trial Phase for zoster vaccine live
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for zoster vaccine live
Clinical Trial Phase	Trials
Completed	10
Not yet recruiting	6
Active, not recruiting	4

Clinical Trial Sponsors for zoster vaccine live

Sponsor Name

Sponsor Name for zoster vaccine live
Sponsor	Trials
GlaxoSmithKline	8
Oregon Health and Science University	2
Oklahoma Medical Research Foundation	2

Sponsor Type

Sponsor Type for zoster vaccine live
Sponsor	Trials
Other	22
Industry	17
NIH	3

Zoster vaccine live Market Analysis and Financial Projection

Last updated: February 8, 2026

What are the latest developments in clinical trials for Zoster Vaccine Live?

Recent updates indicate that the Zoster Vaccine Live (ZVL), marketed as Zostavax, retains ongoing or completed phase 4 post-marketing studies focusing on long-term efficacy, safety, and real-world effectiveness. No active phase 3 trials are currently recruiting or underway for ZVL, as the vaccine has been on the market since 2006. However, post-marketing surveillance continues, emphasizing durability of protection and adverse event monitoring.

There are no public records of new pivotal trials for ZVL. The vaccine’s primary clinical data originate from pre-approval phase 3 trials, notably the Shingles Prevention Study, which demonstrated a 51% reduction in shingles incidence and a 66% reduction in post-herpetic neuralgia.

Recent efforts focus on real-world data collection, comparing ZVL with newer subunit vaccines such as Shingrix (Recombinant Zoster Vaccine), which has gained prominence since its approval in 2017 based on phase 3 trials showing over 90% efficacy.

How does Zoster Vaccine Live currently perform within the market?

Market Penetration and Usage

ZVL primarily targets adults aged 60 years and older, with CDC recommendations emphasizing vaccination at age 50 or above. Despite its long-standing presence, ZVL's market share has declined due to the improved efficacy profile of Shingrix.

Market Size Estimates (2022)

• Estimated global sales: approximately $600 million.
• United States accounts for roughly 70% of market revenue, with sales near $420 million.
• Europe and Asia-Pacific contribute smaller portions due to regulatory delays and limited adoption.

Pricing and Reimbursement

In the U.S., Zostavax is reimbursed through Medicare Part D and private insurers, with average list prices around $200-$250 per dose. Out-of-pocket costs for patients may vary depending on insurance coverage, affecting market penetration.

Competitive Landscape

Shingrix commands a significant market advantage, with a market share surpassing 80% of the shingles vaccine segment. Its higher efficacy and recommendation updates have diminished ZVL’s market position.

What are the projections for Zoster Vaccine Live over the next five years?

Growth Trajectory

• The global market for shingles vaccines is expected to grow at a CAGR of 7.5% from $1.1 billion in 2022 to approximately $1.9 billion by 2027.
• Zoster Vaccine Live's revenue is projected to decline at a CAGR of -4% over the same period as Shingrix solidifies dominance.

Factors Influencing Market Trends

• Regulatory Decisions: Some countries have ceased approval for ZVL due to the superior efficacy of recombinant vaccines.
• Physician Preference: Increased awareness of higher efficacy leads providers to favor newer vaccines.
• Patient Acceptance: Older adults show preference for vaccines with longer-lasting protection, diminishing ZVL's appeal.

Potential Market Resurgence

There are limited scenarios where ZVL could regain market relevance:

• Regulatory approval for use in immunocompromised populations, where live vaccines are traditionally contraindicated.
• Introduction of combination vaccines or reformulations extending the vaccine's shelf life or efficacy.

Regional Considerations

• In emerging markets, ZVL continues to be used due to lower costs and existing infrastructure.
• Approved countries like India and parts of Latin America might sustain ZVL sales longer than regions with rapid adoption of newer vaccines.

Summary of clinical and market developments

Aspect	Details
Clinical trials	No new pivotal phase 3; ongoing post-marketing surveillance
Efficacy	~51% reduction in shingles; ~66% in neuralgia (pre-approval)
Market share	Declined from dominant to minority position (approx. 20% of shingles vaccine market in 2022)
Revenue	Estimated $600 million globally in 2022, primarily U.S.
Future projections	Market decline at -4% CAGR; growth in the broader shingles vaccine segment driven by Shingrix

Key takeaways

• Zoster Vaccine Live maintains a limited presence primarily due to its lower efficacy compared to Shingrix.
• No active development efforts for new pivotal studies suggest that the vaccine’s future hinges on post-marketing data and regional needs.
• The global shingles vaccine market grows steadily, but ZVL's share diminishes as higher-efficacy subunit vaccines become standard.
• Regulatory and regional factors influence maintained use, especially in emerging markets.
• Competitor dominance by non-live vaccines reduces the viability of ZVL without reformulation or new approvals.

FAQs

1. When was Zostavax first approved?
Approved by the FDA in 2006 for adults 60 and older.

2. Are there new clinical trials planned for ZVL?
No publicly known plans for new pivotal phase 3 studies; focus is on post-marketing surveillance.

3. How does Zostavax efficacy compare to Shingrix?
Zostavax offers around 51% efficacy; Shingrix achieves over 90% efficacy in preventing shingles.

4. Is Zostavax still recommended in any countries?
Some regions continue to use ZVL due to cost and infrastructure, but global recommendations favor Shingrix.

5. Can ZVL be used in immunocompromised patients?
No, as a live attenuated vaccine, Zostavax is generally contraindicated for immunocompromised individuals.

---

References

[1] CDC. "Shingles (Herpes Zoster) Vaccination." 2023.
[2] GlaxoSmithKline. "Zostavax Product Label," 2022.
[3] MarketWatch. "Shingles Vaccines Market Size & Trends," 2022.
[4] FDA. "Zostavax Approval and Label Information," 2006.
[5] IQVIA. "Global Vaccines Market Report," 2022.