CLINICAL TRIALS PROFILE FOR VACCINIA IMMUNE GLOBULIN INTRAVENOUS (HUMAN)

All Clinical Trials for vaccinia immune globulin intravenous (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00081835 ↗	Evaluation and Treatment of Eye Complications of Vaccinia Vaccination	Completed	National Eye Institute (NEI)	Phase 2	2004-04-19	This study will evaluate patients with eye complications related to vaccination against smallpox to learn more about these conditions. Vaccinia vaccination has been used for more than 100 years for preventing smallpox. A small number of people who receive the vaccination (less than 1 in 1,000) develop complications, sometimes in their eyes. This usually results from the accidental transfer of the infection from the vaccination site to the face or eyes, perhaps by touching the vaccination area and then the face or eyelids before washing the hands. The study will also examine whether an experimental treatment called NP-016 vaccinia immune globulin can reduce corneal scarring that is sometimes associated with serious vaccinia complications and can impair vision. Children and adults with keratitis, severe conjunctivitis, or blepharitis following exposure to vaccinia vaccination may be eligible for this study. Children must weigh at least 10 kg. Participants undergo the following tests and procedures at enrollment, with some tests repeated at scheduled study visits: 1. Medical history and physical examination 2. Infectious disease consultation 3. Complete eye evaluation including: - Fundus photography to examine the back of the eye - dilation of the pupils with eye drops to examine and photograph the back of the eye - Slit lamp biomicroscopy - evaluation of the front part of the eye with a slit lamp microscope - Eye pressure measurements - Eye swab to look for vaccinia virus or other causes of disease 4. Blood tests 5. Photographs and documentation of eye and skin lesions 6. Vaccinia diagnostic tests, such as skin or mucosa scrapings; blood, throat, or urine cultures; and tissue biopsies, if needed Patients begin treatment with standard medications for their eye disease, such as trifluridine (Viroptic® (Registered Trademark)) anti-viral eye drops. Patients whose condition becomes serious are offered additional treatment with intravenous (through a vein) infusions of either VIG or placebo (salt water solution with no active drug) and are randomly assigned to one or the other treatment group. All patients continue standard-of-care treatment as well. Follow-up visits at the NIH eye clinic are scheduled as required by the patient's condition. Patients with mild complications who are taking only standard medications may need to be seen only 1 month after the initial visit and then 6 months and 12 months later. Patients with more serious conditions who qualify for VIG or placebo treatments may be seen daily for a week, then once a week for the rest of the first month, and then at 6 months and 12 months, unless more frequent treatment or observation is required.
NCT01556347 ↗	Multi-Drug Desensitization Protocol for Heart Transplant Candidates	Terminated	Providence Health & Services	Phase 2	2012-07-01	Background: Patients may develop antibodies (human leukocyte antigen [HLA] alloantibodies) to other human tissues via pregnancy, transfusions or previous transplantation, which limits the ability to find an acceptable donor heart for transplantation. Such patients are at high risk for antibody mediated rejection, graft failure, and acute rejection (i.e. death). For successful transplantation, patients must receive organs from donors who lack the HLA antigens that correspond to their alloantibody specificities. No successful desensitization strategy currently exists. Purpose: To determine if desensitization by deletion of immunologic memory with a multi-drug approach including anti-T and B cell therapies and anti-plasma cell therapy can effectively eliminate or significantly reduce alloantibody levels and permit highly sensitized patients to obtain a heart transplant. This therapy is anticipated to remove immunologic memory and will require re-immunization.

Clinical Trial Conditions for vaccinia immune globulin intravenous (human)

Condition Name

Condition Name for vaccinia immune globulin intravenous (human)
Intervention	Trials
Heart Transplantation	1
Vaccinia	1

Condition MeSH

Condition MeSH for vaccinia immune globulin intravenous (human)
Intervention	Trials
Vaccinia	1

Clinical Trial Locations for vaccinia immune globulin intravenous (human)

Trials by Country

Trials by Country for vaccinia immune globulin intravenous (human)
Location	Trials
United States	2

Trials by US State

Trials by US State for vaccinia immune globulin intravenous (human)
Location	Trials
Washington	1
Maryland	1

Clinical Trial Progress for vaccinia immune globulin intravenous (human)

Clinical Trial Phase

Clinical Trial Phase for vaccinia immune globulin intravenous (human)
Clinical Trial Phase	Trials
Phase 2	2

Clinical Trial Status

Clinical Trial Status for vaccinia immune globulin intravenous (human)
Clinical Trial Phase	Trials
Completed	1
Terminated	1

Clinical Trial Sponsors for vaccinia immune globulin intravenous (human)

Sponsor Name

Sponsor Name for vaccinia immune globulin intravenous (human)
Sponsor	Trials
National Eye Institute (NEI)	1
Providence Health & Services	1

Sponsor Type

Sponsor Type for vaccinia immune globulin intravenous (human)
Sponsor	Trials
NIH	1
Other	1

Clinical Trials Update, Market Analysis, and Projection for Vaccinia Immune Globulin Intravenous (Human)

Last updated: November 4, 2025

Introduction

Vaccinia immune globulin intravenous (human) (VIGIV) is a licensed immunoglobulin used primarily for the treatment of complications arising from vaccinia virus vaccination, notably in immunization programs, and in some cases, for orthopoxvirus infections. As a critical biotherapeutic, VIGIV's market trajectory is influenced by emergent infectious threats, regulatory shifts, and ongoing clinical research. This analysis explores the latest updates in clinical trials, current market dynamics, and future projections, providing insight into strategic considerations for stakeholders.

Clinical Trials Update

Regulatory and Clinical Development Status

VIGIV remains an established therapy, with its primary indication being post-exposure prophylaxis and treatment of severe vaccinia virus infections. It holds FDA approval under the Public Health Emergency framework for treating smallpox vaccine complications, notably in immunocompromised or immunosuppressed individuals.

Recent years have seen limited new clinical trials specifically targeting VIGIV, reflecting its mature regulatory status. Instead, research has pivoted toward exploring expanded indications, novel delivery methods, and comparative efficacy with emerging monoclonal antibody therapies against orthopoxviruses.

Emerging Investigations and Clinical Trials

Despite limited ongoing randomized controlled trials (RCTs), some studies are noteworthy:

• Orthopoxvirus Therapeutic Research: A 2021 clinical trial (NCT04522955) evaluated monoclonal antibodies against orthopoxviruses, indirectly impacting VIGIV's positioning by exploring alternatives and combination therapies.

• Prophylaxis and Treatment in Specific Populations: Investigations into VIGIV's safety and efficacy in immunosuppressed populations remain ongoing, although these trials are often observational in nature, limiting impact on regulatory status.

Impact of Zoonotic and Biothreat Concerns

With the resurgence of interest in orthopoxvirus therapies driven by potential bioweapons use and outbreaks like monkeypox, the clinical landscape shows heightened attention. Governments and defense agencies are particularly interested in ensuring availability, prompting governmental funding for stockpile augmentation rather than new clinical trials.

Regulatory Developments

The FDA’s recent guidance emphasizes preparedness for biothreat agents, including vaccinia virus. The continued stockpiling and emergency use authorizations (EUAs) sustain VIGIV's role, although new indications are pending, reflecting a cautious approach due to the maturity of current clinical evidence.

Market Analysis

Market Size and Segmentation

The global market for vaccinia immune globulin intravenous (VIGIV) was valued at approximately USD 200 million in 2022, with projections forecasting steady growth at a compound annual growth rate (CAGR) of 4–5% through 2030 [1].

Key factors influencing market size include:

• Biodefense and Public Health Policies: Governments stockpile VIGIV as part of biodefense protocols, influencing procurement volumes.
• Off-label and Expanded Indications: Limited, with primary use still centered on vaccinia-related complications.
• Monkeypox Outbreaks: The recent global rise in monkeypox cases has spurred interest in orthopoxvirus-related therapies, including VIGIV, though the supply chain faces strain due to increased demand.

Competitive Landscape

VIGIV is primarily supplied by large biopharmaceutical companies, notably Emergent BioSolutions, Inc., which holds FDA approval and maintains manufacturing capacity for pandemic preparedness. Its monopolistic position limits price competition but underscores supply chain vulnerability.

Emerging monoclonal antibodies targeting orthopoxviruses could disrupt VIGIV's market share, especially if clinical evidence demonstrates superior efficacy or safety profiles.

Pricing and Reimbursement

Price points for VIGIV typically range from USD 3,500 to USD 5,000 per treatment dose, depending on volume and regional factors [2]. Reimbursement is mainly through government health agencies, given its role as a bioterrorism countermeasure, which stabilizes revenue streams but limits market expansion into broader commercial settings.

Regulatory and Supply Chain Challenges

Global supply constraints and regulatory hurdles hinder rapid scale-up during surges in demand, exemplified during recent monkeypox outbreaks. Ensuring sustainable manufacturing capacity and regulatory harmonization remains a critical market challenge.

Future Market Projections

Growth Drivers

• Biodefense Policies: Continued government investments in biodefense EPR (Emergency Preparedness and Response) bolster market stability.
• Emerging Zoonoses: Increased research on orthopoxvirus infections, including monkeypox, may catalyze demand, especially for post-exposure prophylaxis.
• Stockpile Expansion: Governments globally are maintaining and expanding strategic reserves of VIGIV, with potential procurement contracts extending into the next decade.

Constraints and Risks

• Alternatives Development: The advent of monoclonal antibodies and synthetic biologics could diminish VIGIV's prominence.
• Regulatory Limitations: Future approvals for new indications or expanded use cases depend on costly, lengthy trials, with limited pipeline activity.
• Supply Scarcity: Manufacturing complexities and dependency on plasma sources could impede supply chain expansion.

Projection Summary

By 2030, the market for VIGIV is projected to reach USD 250–275 million, driven by steady government contracts and possibly expanded indications owing to orthopoxvirus outbreaks. The growth rate may be tempered by competition from targeted monoclonal antibodies and alternative therapies, alongside supply chain considerations.

Strategic Implications

For stakeholders, maintaining supply chain robustness, engaging in research collaborations, and monitoring biothreat developments are essential to capitalize on the evolving demand landscape. Diversifying therapeutic options and advocating for regulatory flexibility can mitigate risks and unlock new market segments.

Key Takeaways

• Mature Market with Stable Demand: VIGIV remains the primary therapeutic for vaccinia virus complications, with stability driven by biodefense programs and outbreak preparedness, rather than novel clinical indications.

• Heightened Demand from Emerging Infectious Diseases: Recent monkeypox outbreaks have renewed focus on orthopoxvirus therapeutics; however, supply constraints pose challenges.

• Increasing Competition from Monoclonal Antibodies: Emerging biologics targeting orthopoxviruses may overtake VIGIV in certain indications, emphasizing the need for ongoing clinical research.

• Supply Chain and Manufacturing Priorities: Capacity-building and strategic stockpiling underpin future market stability amid unpredictable outbreak patterns.

• Regulatory and Policy Environment: Supportive policies, including EUAs and funding, bolster market resilience but require vigilance for evolving regulations, especially regarding expanded indications.

FAQs

1. What are the primary indications for vaccinia immune globulin intravenous (VIGIV)?
VIGIV is primarily indicated for the treatment and post-exposure prophylaxis of complications arising from vaccinia virus vaccination, particularly in immunocompromised individuals or those with severe vaccine-related adverse effects [1].

2. How could upcoming clinical trials impact VIGIV’s market positioning?
While current trials are limited, ongoing research into monoclonal antibodies and expanded indications could challenge VIGIV's dominance, especially if new therapies demonstrate superior efficacy or safety [3].

3. What role do government stockpiles play in VIGIV’s market?
Government procurement and stockpile maintenance are central to VIGIV’s demand, especially due to its classification as a biodefense countermeasure, thus providing a stable revenue base for manufacturers [2].

4. How might emerging threats like monkeypox influence VIGIV demand?
Outbreaks of monkeypox amplify interest in orthopoxvirus therapeutics. Although VIGIV is not specifically approved for monkeypox, increased usage for post-exposure prophylaxis could elevate demand temporarily, constrained by supply availability.

5. What are the main challenges facing VIGIV’s future market growth?
Key challenges include supply chain limitations, competition from monoclonal antibody therapies, regulatory hurdles for new indications, and the need for ongoing clinical research to expand its therapeutic scope.

References

[1] U.S. Food and Drug Administration. VIGIV (Vaccinia Immune Globulin Intravenous).
[2] MarketWatch. Vaccinia Immune Globulin Market Size, Share & Trends Analysis Report. 2022.
[3] Bell, D., et al. "Orthopoxvirus therapeutics: emerging monoclonal antibodies and future prospects." Journal of Infectious Diseases, 2021.