CLINICAL TRIALS PROFILE FOR RABIES IMMUNE GLOBULIN (HUMAN)

All Clinical Trials for rabies immune globulin (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02564471 ↗	Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.	Completed	Kansas State University	Phase 4	2016-11-11	This is an exploratory trial to evaluate the effect of antimalarial drugs on the immune response generated by rabies vaccine when administered for post-exposure prophylaxis. This study will use the FDA approved post-exposure prophylaxis vaccine regimen (without rabies immune globulin) in the presence or absence of an FDA-approved malaria chemoprophylaxis regimen.
NCT02564471 ↗	Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.	Completed	Walter Reed Army Institute of Research (WRAIR)	Phase 4	2016-11-11	This is an exploratory trial to evaluate the effect of antimalarial drugs on the immune response generated by rabies vaccine when administered for post-exposure prophylaxis. This study will use the FDA approved post-exposure prophylaxis vaccine regimen (without rabies immune globulin) in the presence or absence of an FDA-approved malaria chemoprophylaxis regimen.
NCT02564471 ↗	Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.	Completed	State University of New York - Upstate Medical University	Phase 4	2016-11-11	This is an exploratory trial to evaluate the effect of antimalarial drugs on the immune response generated by rabies vaccine when administered for post-exposure prophylaxis. This study will use the FDA approved post-exposure prophylaxis vaccine regimen (without rabies immune globulin) in the presence or absence of an FDA-approved malaria chemoprophylaxis regimen.
NCT02040090 ↗	Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects	Completed	Kamada, Ltd.	Phase 2/Phase 3	2013-04-01	The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in comparison with Human rabies immune globulin (HRIG) comparator product. 2. To assess whether KamRAB interferes with the development of self active antibodies when given simultaneously with active rabies vaccine, as compared to the HRIG comparator product, also given in conjunction with the active rabies vaccine.

Clinical Trial Conditions for rabies immune globulin (human)

Condition Name

Condition Name for rabies immune globulin (human)
Intervention	Trials
Rabies	2

Condition MeSH

Condition MeSH for rabies immune globulin (human)
Intervention	Trials
Rabies	2

Clinical Trial Locations for rabies immune globulin (human)

Trials by Country

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

Trials by US State

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−

Trials by US State for rabies immune globulin (human)
Location	Trials
New York	1
Minnesota	1

Clinical Trial Progress for rabies immune globulin (human)

Clinical Trial Phase

Clinical Trial Phase for rabies immune globulin (human)
Clinical Trial Phase	Trials
Phase 4	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for rabies immune globulin (human)
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for rabies immune globulin (human)

Sponsor Name

Sponsor Name for rabies immune globulin (human)
Sponsor	Trials
Kansas State University	1
Walter Reed Army Institute of Research (WRAIR)	1
State University of New York - Upstate Medical University	1

Sponsor Type

Sponsor Type for rabies immune globulin (human)
Sponsor	Trials
Other	2
U.S. Fed	1
Industry	1

Rabies Immune Globulin (Human): Clinical Trials, Market Analysis, and Projections

Introduction to Rabies Immune Globulin (HRIG)

Rabies immune globulin (HRIG) is a crucial component in the postexposure prophylaxis (PEP) of rabies, providing immediate passive immunity against the rabies virus. Here, we will delve into recent clinical trials, market analysis, and future projections for HRIG.

Clinical Trials and Efficacy

HyperRAB Clinical Studies

HyperRAB, a high-potency HRIG produced by Grifols, has been extensively studied. In clinical trials, HyperRAB demonstrated a substantial increase in antirabies virus antibody concentrations over a 21-day period, with peak values achieved during this time. The study involved administering a single intramuscular (IM) dose of HyperRAB to eligible subjects, followed by repeated measurements of rabies virus antibody concentrations at various time points. This interim protection is essential until the host immune response to the rabies vaccine produces definitive protective titers of neutralizing rabies antibody[1].

Kamada's HRIG Trials

Kamada Ltd. conducted a pivotal Phase 2/3 clinical trial for their human rabies immune globulin (KamRAB™ or KedRAB™). The trial, involving 118 healthy subjects, evaluated the pharmacokinetic parameters of anti-rabies IgG levels and assessed whether Kamada's IgG interferes with the development of self-active antibodies. The results showed that Kamada's IgG met the primary endpoint of non-inferiority with a difference of -1.8% between the two therapies, and it was safe and well-tolerated with no drug-related serious adverse events[3].

Combination with Rabies Vaccines

Studies have also focused on the combination of HRIG with rabies vaccines. For instance, a phase III trial compared the immunogenicity and safety of a next-generation Vero rabies vaccine (PVRV-NG2) with licensed purified Vero rabies vaccine (PVRV) in a simulated PEP regimen. The trial included concomitant administration of HRIG at day 0 and showed that PVRV-NG2 elicited immune responses consistent with those of licensed vaccines, with higher geometric mean titers and fewer adverse reactions[4].

Safety and Tolerability

Adverse Reactions

Clinical trials and post-marketing studies have generally shown that HRIG is well-tolerated. A prospective post-marketing study involving 4496 patients in a canine rabies endemic region reported only three subjects with adverse reactions, such as redness and itching at the injection sites. None of the patients died during the 18-month follow-up period[5].

HyperRAB Safety Profile

HyperRAB has a robust safety profile, with clinical efficacy data supporting its use. The safety assessments and laboratory tests performed during the clinical study of HyperRAB did not reveal significant adverse events, further reinforcing its safety[1].

Market Analysis

Current Market Size and Growth

The global Human Rabies Immunoglobulin (IM) market was valued at US$ 315 million in 2023 and is expected to reach US$ 396 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 3.2% during the forecast period 2024-2030. This growth is driven by increasing awareness of rabies prevention, advancements in healthcare infrastructure, and the expanding need for effective postexposure treatments[2].

Key Players

The market is dominated by several key players, including CSL Behring, Grifols, Sanofi, Sichuan Yuanda Shuyang, Tiantan Bio, Kamada, CBPO, Shuanglin Bio, Weiguang Bio, Shanghai RAAS, Bharat Serum, and VINS. These companies are investing in research and development to improve the efficacy and availability of HRIG products[2].

Market Segmentation

By Type

The market is segmented into two main types: Equine Rabies Immune Globulin (ERIG) and Human Rabies Immune Globulin (HRIG). HRIG is preferred due to its lower risk of adverse reactions compared to ERIG[2].

By Application

HRIG is primarily used for Category II and Category III exposures, which are the most severe types of exposures to potentially rabid animals. The application in these categories underscores the critical role of HRIG in preventing rabies[2].

Future Projections

Increasing Demand

The demand for HRIG is expected to rise due to the ongoing need for effective rabies prevention, especially in regions where rabies is endemic. The growth in healthcare infrastructure and the increasing awareness about the importance of postexposure prophylaxis will drive the market forward[2].

Technological Advancements

Advancements in technology, such as the development of next-generation vaccines and more potent HRIG formulations like HyperRAB, will continue to improve the efficacy and safety of rabies treatments. These advancements are likely to attract more investment and drive innovation in the market[1][4].

Conclusion

Rabies immune globulin (HRIG) remains a vital component in the fight against rabies, providing immediate protection against this fatal disease. Clinical trials have consistently shown the efficacy and safety of HRIG products, such as HyperRAB and Kamada's HRIG. The market for HRIG is growing steadily, driven by increasing demand and technological advancements. As healthcare infrastructure improves and awareness about rabies prevention increases, the future looks promising for HRIG.

Key Takeaways

• Efficacy and Safety: HRIG has been proven to be effective and safe in clinical trials.
• Market Growth: The global HRIG market is expected to grow at a CAGR of 3.2% from 2024 to 2030.
• Key Players: Major companies like Grifols, Kamada, and CSL Behring are leading the market.
• Technological Advancements: Next-generation vaccines and potent HRIG formulations are improving treatment outcomes.
• Increasing Demand: Growing awareness and healthcare infrastructure are driving the demand for HRIG.

FAQs

Q: What is the primary role of HRIG in rabies treatment?

A: HRIG provides immediate passive immunity against the rabies virus, offering interim protection until the host immune response to the rabies vaccine produces definitive protective titers.

Q: Which companies are major players in the HRIG market?

A: Key players include CSL Behring, Grifols, Sanofi, Kamada, and several others.

Q: What is the expected market size of HRIG by 2030?

A: The global HRIG market is expected to reach US$ 396 million by 2030.

Q: How safe is HRIG?

A: Clinical trials and post-marketing studies have shown that HRIG is generally well-tolerated with minimal adverse reactions.

Q: What are the main types of HRIG?

A: The main types are Equine Rabies Immune Globulin (ERIG) and Human Rabies Immune Globulin (HRIG), with HRIG being preferred due to its lower risk of adverse reactions.

Sources

1. HyperRAB Postexposure Treatment for Rabies | Official Site. HyperRAB.
2. Human Rabies Immunoglobulin (IM) Market Size - Valuates Reports. Valuates Reports.
3. Kamada's Human Rabies Immune Globulin Successfully Meets Primary Endpoint in U.S. Pivotal Phase 2/3 Clinical Trial as a Post-Exposure Treatment. Kamada.
4. Randomized Controlled Trial of the Immunogenicity and Safety of a Serum-Free, Highly Purified Vero Rabies Vaccine–Next Generation (PVRV-NG2). Oxford Academic.
5. A Study of Human Rabies Immune Globulin Manufactured by the Thai Red Cross Society. PubMed.