CLINICAL TRIALS PROFILE FOR HEPATITIS B IMMUNE GLOBULIN (HUMAN)

All Clinical Trials for hepatitis b immune globulin (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000580 ↗	Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1975-11-01	To evaluate whether hepatitis B immune globulin with a high level of antibody against the hepatitis B antigen would be capable of interrupting maternal-fetal transmission of hepatitis B virus, the single most important route of hepatitis spread in the entire Third World.
NCT00006630 ↗	Vaccinia Immune Globulin in Treating or Preventing Vaccinal Infection	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to follow responses to treatment with vaccinia immune globulin (VIG) for safety and clinical benefit [during HIV vaccine research]. VIG is purified from human blood and used to treat serious infections of the vaccinia (smallpox vaccine) virus or similar viruses. It is the only treatment available for those viruses. The only available supply of VIG has developed a discoloration over time and therefore is considered an investigational new drug by the FDA. This study will allow it to be used for intramuscular injection in a controlled setting for people who may need it [during HIV vaccine research].
NCT00031291 ↗	Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin	Completed	National Institutes of Health Clinical Center (CC)		2002-02-01	This protocol is a joint project of the National Institutes of Health, the Centers for Disease Control and the United States Army Medical Research Institute for Infectious Diseases. It is designed to collect plasma from healthy employees of the Department of Defense who have been vaccinated against anthrax. The collected plasma will be pooled to make an anthrax-fighting antibody solution called anthrax immune globulin intravenous (AIGIV). This solution will be used for: - Animal experiments to test its effectiveness in preventing the development of anthrax after inhalation exposure; - Treating people severely ill with anthrax who are not improving with standard antibiotic therapy; and - Treating people exposed to spores of the bacteria that cause anthrax to try to prevent development of the disease. Healthy volunteers between 18 and 65 years of age who have received at least four doses of the anthrax vaccine and who meet the criteria for blood donors may be eligible to participate in this study. Volunteers will be recruited from Department of Defense civilian and military employees. Candidates will be screened with an interview and blood tests. Participants will undergo the following procedures: - Have a health history screen for donating plasma - Measurement of heart rate, blood pressure and temperature - Fingerstick to check hemoglobin level - Blood tests for HIV, hepatitis B and C, syphilis and other infectious diseases - Blood test for anthrax antibody levels - Plasmapheresis to collect blood plasma (the liquid part of the blood) In plasmapheresis, whole blood is drawn through a needle placed in an arm vein. The blood flows into a cell separator machine, where it is spun to separate the plasma from the blood cells. The plasma is collected in a plastic bag in the machine, while the rest of the blood is returned to the donor through the needle in the arm. During the procedure, the donor is given a blood thinner called citrate to prevent the blood from clotting while it is in the cell separator machine. The procedure lasts from 60 to 90 minutes. Only a small fraction of the body's total plasma is removed, and it is quickly replaced by the body with no long-term health effects. Participants may be requested to donate plasma as often as every 3 to 4 days or as infrequently as once a month for a maximum of six donations.
NCT00059267 ↗	Prevention of Recurrent Hepatitis B After Liver Transplantation	Completed	University of Michigan		2001-03-01	Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance. Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage. Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it may be possible to tailor the preventive therapy according to the risk. The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation.
NCT00059267 ↗	Prevention of Recurrent Hepatitis B After Liver Transplantation	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)		2001-03-01	Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance. Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage. Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it may be possible to tailor the preventive therapy according to the risk. The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation.

Clinical Trial Conditions for hepatitis b immune globulin (human)

Condition Name

Condition Name for hepatitis b immune globulin (human)
Intervention	Trials
Hepatitis B	9
Liver Transplantation	4
Hepatitis B, Chronic	2
Chronic Hepatitis B	2

Condition MeSH

Condition MeSH for hepatitis b immune globulin (human)
Intervention	Trials
Hepatitis B	15
Hepatitis	14
Hepatitis A	13
Hepatitis B, Chronic	6

Clinical Trial Locations for hepatitis b immune globulin (human)

Trials by Country

Trials by Country for hepatitis b immune globulin (human)
Location	Trials
United States	12
China	9
Thailand	6
Spain	2
Nepal	2

Trials by US State

Trials by US State for hepatitis b immune globulin (human)
Location	Trials
Maryland	3
Virginia	1
Pennsylvania	1
Ohio	1
North Carolina	1

Clinical Trial Progress for hepatitis b immune globulin (human)

Clinical Trial Phase

Clinical Trial Phase for hepatitis b immune globulin (human)
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	3
Phase 3	4

Clinical Trial Status

Clinical Trial Status for hepatitis b immune globulin (human)
Clinical Trial Phase	Trials
Completed	10
Recruiting	6
Unknown status	2

Clinical Trial Sponsors for hepatitis b immune globulin (human)

Sponsor Name

Sponsor Name for hepatitis b immune globulin (human)
Sponsor	Trials
Instituto Grifols, S.A.	3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2
National Heart, Lung, and Blood Institute (NHLBI)	2

Sponsor Type

Sponsor Type for hepatitis b immune globulin (human)
Sponsor	Trials
Other	18
Industry	7
NIH	7

Clinical Trials Update, Market Analysis, and Projection for Hepatitis B Immune Globulin (Human)

Last updated: November 15, 2025

Introduction

Hepatitis B immune globulin (HBIG), a serum-derived immunoglobulin, serves as a critical post-exposure prophylactic agent against hepatitis B virus (HBV) infection. Given the persistent burden of HBV worldwide—estimated at over 296 million chronic infections globally—advancements in therapeutics such as HBIG are vital. This analysis synthesizes recent clinical trials, global market dynamics, and future prospects for HBIG (human), providing key insights for stakeholders.

Clinical Trials Update

Recent clinical trials focus primarily on optimizing HBIG efficacy, safety, and delivery methods, while simultaneously exploring recombinant alternatives that could transcend limitations of plasma-derived products.

Current Clinical Trials

• Efficacy and Safety in Post-Exposure Prophylaxis: Multiple ongoing trials evaluate the administration of HBIG in conjunction with hepatitis B vaccination, especially in high-risk populations such as healthcare workers, infants born to HBV-infected mothers, and individuals exposed via occupational or accidental routes. These studies aim to refine dosage regimens and administration timing, with preliminary data indicating improved seroprotection rates when HBIG is administered within 24 hours post-exposure (clinical trial identifiers: NCT04596366, NCT04944588)[1].

• Recombinant and Monoclonal Antibody Development: Recognizing limitations in plasma-derived HBIG, including supply constraints and batch variability, pharmaceutical companies are investigating recombinant monoclonal antibodies targeting the HBV surface antigen (HBsAg). Recent trials trial these monoclonals for prophylactic efficacy and cost-effectiveness (e.g., NCT04625741). Early-phase results suggest promising neutralization capabilities comparable to traditional HBIG.

• Combination Therapies: Trials explore integrating HBIG with antiviral agents such as tenofovir or entecavir to improve management of chronic HBV infections. These studies focus on reducing viral load and preventing reactivation, with initial outcomes demonstrating synergistic effects.

Regulatory and Developmental Trends

While plasma-based HBIG remains the standard of care, regulatory agencies are increasingly endorsing recombinant approaches. The U.S. FDA has approved several monoclonal antibody candidates in early development stages, indicating a shifting landscape toward more standardized, scalable options (FDA, 2022).

Market Analysis

Global Market Landscape

The global HBIG market was valued at approximately USD 850 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4.2% through 2030[2].

Key Market Drivers

• Rising HBV Prevalence: Despite vaccination efforts, HBV remains endemic in many regions, particularly Sub-Saharan Africa and Southeast Asia. Continued high prevalence sustains demand for HBIG in post-exposure settings.

• Vaccination Gaps and Perinatal Transmission: Gaps in immunization programs and high rates of vertical transmission bolster the need for effective prophylactic agents like HBIG, especially in developing countries.

• Expanding Indications: Growing evidence supports HBIG’s use in liver transplant recipients and high-risk patients, further broadening the market.

Regional Market Dynamics

• North America & Europe: Mature markets characterized by high awareness, established infrastructure, and preference for plasma-derived products. However, growing interest in recombinant alternatives is expected to influence future market shares.

• Asia-Pacific: Fastest-growing region due to high HBV endemicity, expanding healthcare infrastructure, and increasing vaccination rates. Countries like India and China represent lucrative markets, potentially accounting for over 50% of global demand by 2030.

Market Challenges

• Supply Constraints: Dependence on plasma donation poses limited scalability, especially during global events affecting donors.

• Pricing and Cost: High manufacturing costs and logistics impact affordability, particularly in low-resource settings.

• Regulatory Hurdles: Approval pathways for recombinant products are complex, potentially delaying market entry.

Competitive Landscape

Major players include GlaxoSmithKline (GSK), Sanofi, and China-based companies like Wuhan Institute of Biological Products, which possess existing plasma-derived HBIG products[3]. The race to develop recombinant and monoclonal alternatives is intensifying, with several candidates entering clinical phases.

Market Projections and Future Outlook

The HBIG market is poised for moderate growth, driven by demand in both prophylactic and therapeutic niches. The emergence of recombinant monoclonal antibodies may disrupt traditional plasma-based products.

• Recombinant HBIG: Expected to capture a significant share by 2030. Advantages include standardized production, reduced batch variability, and improved safety profiles.

• Market Penetration: While plasma-derived HBIG will maintain prominence in emerging markets due to cost constraints, developed regions might shift toward recombinant options as costs decline and approval processes expedite.

• Innovative Delivery Platforms: Advances in nanotechnology and sustained-release formulations hold potential for enhancing patient compliance and reducing dosing frequency.

Long-term Projections

By 2030, the market is likely to witness a dual-product ecosystem: established plasma-derived HBIG supplemented or replaced by recombinant and monoclonal alternatives. The global market could reach USD 1.2 billion, with Asia-Pacific accounting for nearly half of sales.

Key Takeaways

• Continuous clinical trials focus on enhancing HBIG efficacy, safety, and exploring recombinant alternatives, which promise scalability and batch consistency advantages.

• The global HBIG market is expanding steadily, driven by high HBV endemicity, vaccination gaps, and the need for effective prophylaxis.

• Increasing adoption of recombinant monoclonal antibodies is anticipated, especially in developed markets, potentially transforming the therapeutic landscape.

• Supply chain, manufacturing costs, and regulatory pathways remain critical barriers, requiring strategic focus for pharmaceutical developers.

• The integration of innovative delivery technologies and combination therapies will shape future market growth and treatment paradigms.

Conclusion

Hepatitis B immune globulin (human) remains an indispensable tool in HBV prophylaxis, with ongoing clinical trials advancing its efficacy profile and alternative forms. Market dynamics are shifting, underpinned by technological innovations and regional epidemiological factors. Stakeholders should monitor the evolving clinical pipeline and regulatory environment to adapt strategies accordingly, ensuring sustained supply, improved patient outcomes, and market competitiveness.

FAQs

1. What are the main limitations of plasma-derived HBIG?
Plasma-derived HBIG faces supply constraints, risk of transfusion-transmitted infections, batch-to-batch variability, and high production costs. These limitations motivate the development of recombinant alternatives.

2. How soon are recombinant monoclonal antibodies expected to replace traditional HBIG?
While early-phase clinical trials show promise, widespread adoption depends on successful regulatory approval, cost competitiveness, and proven efficacy. Likely within the next 5–10 years in developed markets.

3. What is the role of HBIG in current hepatitis B management?
HBIG is primarily used for post-exposure prophylaxis, especially in newborns of HBV-infected mothers and healthcare workers exposed to blood-borne HBV. It is also used in liver transplant settings to prevent reinfection.

4. How does regional variation impact HBIG market development?
High HBV prevalence in regions like Asia-Pacific boosts demand but also presents challenges related to infrastructure and affordability. Developed regions prioritize recombinant products, influencing market segmentation.

5. Are there ongoing efforts to develop oral or alternative delivery forms of HBIG?
Current research mainly targets injectable formulations; oral or alternative delivery methods are not yet advanced but represent potential areas for future innovation to improve compliance.

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Sources:

[1] Clinical trial registries: NCT04596366, NCT04944588, NCT04625741
[2] Market research reports: Global Hepatitis B Immunoglobulin Market, 2022–2030
[3] Industry reports: Major pharmaceutical players and their product pipelines