CLINICAL TRIALS PROFILE FOR RABIES VACCINE

All Clinical Trials for rabies vaccine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02374814 ↗	Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis	Completed	Walter Reed Army Institute of Research (WRAIR)	Phase 4	2015-03-24	The purpose of this study is to compare the effectiveness of a two dose versus a three dose schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.
NCT02374814 ↗	Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis	Completed	State University of New York - Upstate Medical University	Phase 4	2015-03-24	The purpose of this study is to compare the effectiveness of a two dose versus a three dose schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.
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.
NCT01165645 ↗	Lopinavir and Ritonavir in Improving Immune Response to Vaccines in Patients With Complete Remission Following A Bone Marrow Transplant for Hodgkin Lymphoma	Withdrawn	Mayo Clinic	N/A	2010-11-01	RATIONALE: HIV protease inhibitors, including Lopinavir/Ritonavir have intrinsic anti-apoptotic properties in addition to their anti-viral effect on HIV. This anti-apoptotic effect may boost the immune system to help the body create a better immune response to vaccines. PURPOSE: This randomized clinical trial studies giving lopinavir and ritonavir together in improving immune response to vaccines in patients with complete remission following a bone marrow transplant for Hodgkin lymphoma.
NCT00740090 ↗	Malaria Vaccine for Children in Mali	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2008-08-11	This study will evaluate the safety and immune response of children to an experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by certain kinds of mosquitoes. It affects at least 300 million people worldwide each year, with more than 1 million deaths, mostly among children less than 5 years of age in sub-Saharan Africa. Malaria is the leading cause of death and illness among the general population of Mali in West Africa. Increasing drug resistance to P. falciparum and widespread resistance of mosquitoes to pesticides are reducing the ability to control the disease through these strategies. AMA1 C1 is made from a synthetic protein similar to a P. falciparum protein. It is combined with Alhydrogel and CPG 7909, substances added to vaccines to make them work better. Children between 1 and 4 years of age who live in Bancoumana, Mali, and are in general good health may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants are randomly assigned to receive three injections (shots) of either AMA1-C1 or a control rabies inactivated vaccine called Imovax® (Registered Trademark). The shots are given in the thigh muscle on study days 0, 56 and 180. After each shot, participants are observed in the clinic for 30 minutes. They return to the clinic for a physical examination six or seven times between each shot and then four more times over a 9-month period after the last shot. Blood samples are drawn at several of these visits to check for side effects of the vaccine and to measure the response to it. The total duration of the study is 21 months. ...
NCT00100646 ↗	Anti-HIV Treatment Interruptions in HIV Infected Adults in South Africa	Completed	The Wistar Institute	N/A	2007-03-01	HIV infected people often must take anti-HIV drugs for long periods, leading to long-term drug exposure and toxicity. Interruptions in anti-HIV therapy, also known as structured treatment interruptions (STIs), may have few negative health effects and may be helpful to the overall long-term health of HIV-infected people. The purpose of this study is to determine if sequential short-term STIs of antiretroviral therapy (ART) in HIV infected individuals in a resource-constrained environment can retain the immune reconstitution benefits of continuous treatment while potentially lessening rates of toxicity associated with continuous therapy strategies and at the same time, lessen costs associated with ART.
NCT00031070 ↗	Increasing HAART-Induced Immune Restoration With Cyclosporine	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	The purpose of this study is to see if cyclosporine, taken when a patient begins highly active antiretroviral therapy (HAART), increases the number of CD4 T-cells (blood cells that fight infection) in a patient's blood. This study also will explore the safety of briefly giving cyclosporine to patients starting HAART.

Clinical Trial Conditions for rabies vaccine

Condition Name

Condition Name for rabies vaccine
Intervention	Trials
Rabies	4
HIV Infections	2
Healthy	1
Stage I Adult Hodgkin Lymphoma	1

Condition MeSH

Condition MeSH for rabies vaccine
Intervention	Trials
Rabies	11
HIV Infections	2
Diarrhea	1
Lymphoma	1

Clinical Trial Locations for rabies vaccine

Trials by Country

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Trials by Country for rabies vaccine
Location	Trials
United States	23
Mali	1
China	1
South Africa	1
Bangladesh	1

Trials by US State

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−

Trials by US State for rabies vaccine
Location	Trials
Minnesota	4
New York	3
North Carolina	2
Maryland	2
Florida	2

Clinical Trial Progress for rabies vaccine

Clinical Trial Phase

Clinical Trial Phase for rabies vaccine
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for rabies vaccine
Clinical Trial Phase	Trials
Completed	10
Active, not recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for rabies vaccine

Sponsor Name

Sponsor Name for rabies vaccine
Sponsor	Trials
Kamada, Ltd.	2
Walter Reed Army Institute of Research (WRAIR)	2
State University of New York - Upstate Medical University	2

Sponsor Type

Sponsor Type for rabies vaccine
Sponsor	Trials
Other	14
Industry	6
U.S. Fed	2

Rabies Vaccine: Clinical Trials, Market Analysis, and Projections

Introduction to Rabies and the Need for Vaccines

Rabies is a deadly viral disease that affects the nervous system of mammals, including humans. It is primarily transmitted through the bite of an infected animal, and if left untreated, it is almost always fatal. The development and advancement of rabies vaccines are crucial in the global fight against this disease.

Recent Clinical Trials and Developments

Jefferson Rabies Virus-based Vaccine

A significant development in the field of rabies vaccines comes from researchers at Thomas Jefferson University, the University of Maryland Baltimore, and collaborators. A rabies virus-based vaccine, supported by a $30 million contract from the NIH/NIAID, has shown promising results in preclinical animal models. This vaccine, which has been in development for over a decade, is set to enter its first human study in November 2024. The study published in npj Vaccines on August 9, 2024, indicates that the vaccine effectively prevents severe cases of the disease and death in non-human primates[1].

PIKA Rabies Vaccine by YS Biopharma

YS Biopharma has announced positive interim results from the pivotal Phase 3 clinical trial of their PIKA Rabies Vaccine. This vaccine utilizes YS Biopharma’s proprietary PIKA adjuvant technology to produce a more robust immune response in a shorter timeframe compared to existing vaccines. The trial, involving 4,500 participants from the Philippines and Pakistan, has met its primary endpoints and shows potential for achieving the WHO’s goal of a one-week rabies vaccine regimen. This could significantly improve treatment compliance and outcomes[3].

ChAdOx2 RabG Vaccine by University of Oxford

Researchers at the University of Oxford have reported promising results from a Phase 1 clinical trial of their single-shot rabies vaccine, ChAdOx2 RabG. This vaccine, based on the ChAdOx2 vector (a weakened version of a common cold virus), has shown strong safety and immune response data. The trial, conducted at the University of Oxford, analyzed levels of rabies neutralizing antibodies and supports further development of this approach. A Phase Ib/II clinical trial in Tanzania is also ongoing, with results expected later this year[4].

Market Analysis and Projections

Human Rabies Vaccine Market

The human rabies vaccine market is expected to grow significantly in the coming years. Here are some key points:

• Market Size and Growth: The market is estimated to reach $970 million by 2025, growing at a CAGR of 6% from 2019 to 2025. The Vero Cells Rabies vaccine segment holds the highest revenue and market share due to its feasibility and wider application[2].
• Geographical Distribution: North America holds the largest market share, accounting for 30% of the revenue, driven by advancements in the healthcare sector[2].
• Driving Factors: Growing awareness about rabies prevention, government support, and educational initiatives are key drivers of the market. However, lack of resources and adequate vaccine supply in developing nations hinder market growth in these regions[2].

Veterinary Rabies Vaccine Market

The veterinary rabies vaccine market is also seeing substantial growth:

• Market Size and Growth: The global veterinary rabies vaccines market was estimated at $785.0 million in 2024 and is anticipated to grow at a CAGR of 5.9% from 2025 to 2030, reaching $1.10 billion by 2030[5].
• Geographical Distribution: North America dominates the market with over 38% share, driven by a large pet population and mandatory rabies vaccination measures[5].
• Driving Factors: Increasing government initiatives to eradicate animal rabies, rising awareness of zoonotic diseases, and growing pet ownership rates are driving the market. Mass dog vaccination campaigns and wildlife rabies-eradication bait programs also contribute to market growth[5].

Key Players in the Market

Both the human and veterinary rabies vaccine markets have several key players:

• Human Market: Companies like YS Biopharma, with their PIKA Rabies Vaccine, and researchers from institutions like Thomas Jefferson University and the University of Oxford are making significant contributions[1][3][4].
• Veterinary Market: Major players include Merck & Co. (MSD Animal Health), Indian Immunologicals Ltd, Boehringer Ingelheim International GmbH (Animal Health), Zoetis, Virbac, and others[5].

Challenges and Opportunities

Challenges

• Resource Constraints: Lack of resources and adequate vaccine supply in developing nations remain significant challenges for both human and veterinary rabies vaccine markets[2][5].
• Compliance and Treatment Regimens: The long and inconvenient treatment regimens of existing rabies vaccines can lead to poor compliance, highlighting the need for shorter, more efficient regimens like the PIKA Rabies Vaccine[3].

Opportunities

• Advanced Technologies: The use of modern vaccine technologies, such as the ChAdOx2 vector and PIKA adjuvant technology, offers opportunities for more effective and quicker immune responses[3][4].
• Government Initiatives: Increasing government initiatives to eradicate rabies and rising awareness about zoonotic diseases present opportunities for market growth and expansion[2][5].

Future Outlook

The future of rabies vaccines looks promising with ongoing clinical trials and advancements in technology. Here are some key takeaways:

• Clinical Trials: Ongoing and upcoming clinical trials, such as those for the Jefferson Rabies Virus-based Vaccine and the ChAdOx2 RabG Vaccine, are expected to provide further insights into the efficacy and safety of new vaccine candidates[1][4].
• Market Growth: Both the human and veterinary rabies vaccine markets are projected to grow significantly, driven by increasing awareness, government initiatives, and technological advancements[2][5].

Key Takeaways

• Advanced Vaccine Technologies: New vaccine candidates using modern technologies like PIKA adjuvant and ChAdOx2 vector are showing promising results.
• Market Growth: The human and veterinary rabies vaccine markets are expected to grow at CAGRs of 6% and 5.9%, respectively.
• Government Support: Increasing government initiatives and educational programs are driving market growth.
• Resource Challenges: Developing nations face challenges due to lack of resources and adequate vaccine supply.
• Compliance Improvement: Shorter treatment regimens could improve compliance and treatment outcomes.

FAQs

What are the latest developments in rabies vaccine clinical trials?

The latest developments include the entry of a Jefferson Rabies Virus-based Vaccine into its first human study, positive interim results from the PIKA Rabies Vaccine Phase 3 trial, and promising data from the ChAdOx2 RabG single-shot vaccine Phase 1 trial[1][3][4].

How is the market for rabies vaccines projected to grow?

The human rabies vaccine market is projected to reach $970 million by 2025, growing at a CAGR of 6%, while the veterinary rabies vaccine market is expected to reach $1.10 billion by 2030, growing at a CAGR of 5.9%[2][5].

What are the key factors driving the growth of the rabies vaccine market?

Key factors include growing awareness about rabies prevention, government support, educational initiatives, and increasing pet ownership rates. For the veterinary market, mass dog vaccination campaigns and wildlife rabies-eradication bait programs also play a significant role[2][5].

Which companies are major players in the rabies vaccine market?

Major players in the human market include YS Biopharma and researchers from institutions like Thomas Jefferson University and the University of Oxford. In the veterinary market, companies like Merck & Co., Indian Immunologicals Ltd, and Boehringer Ingelheim International GmbH are prominent[1][3][4][5].

What challenges do developing nations face in accessing rabies vaccines?

Developing nations face challenges due to lack of resources and adequate vaccine supply, which hinders market growth and access to these critical vaccines[2][5].

Sources

1. Jefferson Rabies Virus-based Vaccine Enters First Human Study in 2024. Jefferson University.
2. Rabies Vaccine Market - Forecast(2024 - 2030). IndustryARC.
3. YS Biopharma Announces Positive Interim Results of Pivotal Phase 3 Clinical Study of PIKA Rabies Vaccine. BioSpace.
4. First clinical trial data for new rabies vaccine candidate demonstrates promising immune response. University of Oxford.
5. Rabies Veterinary Vaccines Market | Industry Report, 2030. Grand View Research.