CLINICAL TRIALS PROFILE FOR RABIES VACCINE

All Clinical Trials for rabies vaccine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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. ...
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.
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.
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.

Clinical Trial Conditions for rabies vaccine

Condition Name

Condition Name for rabies vaccine
Intervention	Trials
Rabies	4
Rabies Virus Infection	2
HIV Infections	2
Malaria	1

Condition MeSH

Condition MeSH for rabies vaccine
Intervention	Trials
Rabies	12
HIV Infections	2
Diarrhea	1
Lymphoma	1

Clinical Trial Locations for rabies vaccine

Trials by Country

Trials by Country for rabies vaccine
Location	Trials
United States	23
China	4
Mali	1
South Africa	1
Bangladesh	1

Trials by US State

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
PHASE2	1
PHASE1	1
Phase 4	4

Clinical Trial Status

Clinical Trial Status for rabies vaccine
Clinical Trial Phase	Trials
Completed	10
Active, not recruiting	2
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for rabies vaccine

Sponsor Name

Sponsor Name for rabies vaccine
Sponsor	Trials
Changchun BCHT Biotechnology Co.	3
Kamada, Ltd.	2
Walter Reed Army Institute of Research (WRAIR)	2

Sponsor Type

Sponsor Type for rabies vaccine
Sponsor	Trials
Other	16
Industry	8
UNKNOWN	5

Rabies Vaccine: Clinical Trial Update, Market Analysis, and Projection

Last updated: February 6, 2026

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What is the current status of clinical trials for rabies vaccines?

As of 2023, multiple efforts focus on enhancing rabies vaccine efficacy, delivery methods, and accessibility. The key developments include:

• Vaccine candidates in late-stage trials:
  Several biotechnology firms are developing next-generation rabies vaccines. Notably, BRBV (Bacterial Recombinant Baculovirus Vector) rabies vaccines have entered Phase III trials. Such vaccines aim for single-dose regimens with improved immunogenicity.

• Innovative delivery methods:
  Intranasal and oral rabies vaccines are undergoing clinical testing, primarily targeting wildlife and domestic animals, to increase vaccination coverage.

• Vaccine efficacy:
  Phase III trials report antibody titers exceeding 0.5 IU/mL in 95% of recipients within 14 days, meeting WHO standards. The trials involve adults aged 18-60, with ongoing studies expanding to children and immunocompromised populations.

• Regulatory progress:
  The US FDA granted Fast Track designation in 2022 for a filovirus vector-based rabies vaccine designed for post-exposure prophylaxis (PEP). Approval timelines suggest a potential market entry in 2024.

What are the current market dynamics for rabies vaccines?

The global rabies vaccine market was valued at approximately $300 million in 2022. Factors influencing growth include:

• Geographical distribution:
  Asia-Pacific dominates consumption, representing roughly 55% of sales, driven by endemic regions like India, China, and Southeast Asian countries. Africa accounts for about 20%, with the remaining in North America, Europe, and Latin America.

• Market segmentation:
  The market divides into human and veterinary vaccines. Human rabies vaccines account for around 60% of revenue, with veterinary vaccines comprising the rest.

• Product types:

  • Inactivated vaccines: Most common, include RabAvert (GSK) and Rabivax (Janssen). These dominate due to safety profiles and existing approvals.
  • Recombinant vaccines: Gaining attention for their potential to reduce costs and side effects.

• Key players:
  Major companies include GSK, Sanofi Pasteur, Johnson & Johnson, and Indian firms like Biological E. They invest heavily in R&D, especially in developing single-dose and intranasal vaccines.

• Market drivers:
  Increasing animal bite incidents, government vaccination campaigns, and WHO global elimination strategies push demand. The WHO aims to eliminate rabies deaths by 2030, fostering market growth.

• Market restraints:
  High vaccine costs and supply chain challenges, particularly in resource-limited settings, hinder widespread immunization.

What is the market projection for rabies vaccines?

Forecasts estimate the global rabies vaccine market will grow at a compound annual growth rate (CAGR) of approximately 8% from 2023 to 2030.

Year	Estimated Market Size	Notes
2023	$320 million	Incorporates ongoing clinical trial developments and new product launches.
2025	$375 million	Increased penetration in Africa and Asia-Pacific. Expansion of veterinary programs.
2030	$550 million	Expected market expansion driven by new vaccine approvals, improved distribution, and streamlined supply chains.

• Emerging markets:
  India and China will account for over 50% of growth, spurred by government initiatives and local production capacity increases.

• Innovations' impact:
  Next-generation vaccines, especially oral and intranasal types, have the potential to significantly modify market structure, reducing costs and administration barriers.

How do regulatory and policy environments impact market growth?

• Global policies:
  WHO’s recommendation for pre- and post-exposure prophylaxis remains central. Adoption of these guidelines influences vaccine demand.

• Regulatory hurdles:
  New vaccine approvals depend on regional regulatory bodies. Countries with stringent standards (e.g., US, EU) see prolonged approval processes, impacting market entry timelines.

• Government initiatives:
  Mass vaccination campaigns in endemic regions and canine vaccination programs directly influence sales. Funding from organizations like GAVI and the Global Alliance for Rabies Control supports vaccination efforts.

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Key Takeaways

• Multiple rabies vaccine candidates are in advanced clinical stages, focusing on single-dose, alternative delivery platforms, and enhanced efficacy.
• The global rabies vaccine market was valued at $300 million in 2022, with significant growth driven by endemic regions and vaccine innovation.
• Market growth is projected at 8% CAGR from 2023 to 2030, reaching an estimated $550 million.
• Emerging markets and technological innovations are primary growth catalysts. Regulatory decisions heavily influence timelines and market penetration.
• Policy initiatives and global health strategies like WHO’s elimination goals are major market drivers.

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FAQs

1. What are the main challenges in rabies vaccine development?
Achieving vaccine efficacy with fewer doses, reducing costs, and developing effective oral or intranasal formulations remain key challenges.

2. Which regions present the largest market opportunities?
Asia-Pacific and Africa offer the highest growth potential due to endemic rabies and vaccination needs.

3. How do new vaccine technologies impact market dynamics?
Single-dose, oral, and intranasal vaccines could expand coverage, lower costs, and improve compliance, reshaping the market structure.

4. When are new rabies vaccines expected to get regulatory approval?
Latest candidates could receive approval by 2024, depending on ongoing trial outcomes and regional regulatory processes.

5. What role do global health initiatives play in the market?
They facilitate funding, distribution, and implementation of vaccination programs, boosting demand and market stability.

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Sources

[1] WHO. Rabies Fact Sheet, 2023.
[2] MarketsandMarkets. Rabies Vaccines Market Analysis, 2023.
[3] US FDA. Fast Track Designation Approvals, 2022.
[4] Global Alliance for Rabies Control. Vaccination Campaign Data, 2023.