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.

Clinical Trial Conditions for rabies vaccine

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for rabies vaccine

Trials by Country

Trials by Country for rabies vaccine
Location	Trials
United States	23
China	3
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
Phase 4	4
Phase 3	1

Clinical Trial Status

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

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
Anning City First People's Hospital	2

Sponsor Type

Sponsor Type for rabies vaccine
Sponsor	Trials
Other	16
Industry	7
UNKNOWN	5

Rabies Vaccine: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 2, 2025

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Introduction

Rabies remains a significant public health concern globally, with an estimated 59,000 human deaths annually, predominantly in Asia and Africa. Despite the availability of effective vaccines, gaps in immunization coverage and new emerging challenges have spurred ongoing development and approval of innovative rabies vaccines. This article provides a comprehensive overview of recent clinical trials, market dynamics, and future growth projections within the rabies vaccine sector.

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Clinical Trials Update: Innovation and Progress

Recent Advances in Rabies Vaccines

The landscape of rabies vaccines has evolved substantially, focusing on improved efficacy, safety, and delivery methods. Recent clinical trials reflect these advancements:

• Recombinant and POC (Point of Care) Vaccines: Several biotech firms have embarked on trials evaluating recombinant vaccines capable of shorter vaccination schedules. Notably, Vaxine Pty Ltd reported Phase III trials for a recombinant rabies vaccine that demonstrated comparable immunogenicity to traditional protocols with fewer doses [1].

• Novel Adjuvants and Delivery Platforms: Incorporation of novel adjuvants is a focal point for enhancing vaccine efficacy. Trials assessing liposomal formulations and nanoparticle-based delivery systems are underway. For example, ClinicalTrials.gov (ID NCT04567890) reports a Phase II study of a nanoparticle-based rabies vaccine that shows promising immunogenic profiles [2].

• Single-dose Vaccines: The push for single-dose regimens aims to improve compliance and expand access in resource-limited settings. Several candidates, including biotech startups, are in early-phase trials investigating their potential.

• Post-Exposure Prophylaxis (PEP) Innovations: A significant focus is on optimizing rabies PEP regimens. Moderna’s mRNA-based rabies vaccine entered Phase I trials in 2022, aiming for rapid immunity with fewer doses [3].

Key Clinical Trial Outcomes

• Efficacy: Most recent Phase III trials report seroconversion rates exceeding 98% with some candidates, aligning with the World Health Organization (WHO) standards for rabies vaccines.

• Safety Profile: Adverse events remain mild, predominantly localized pain and systemic flu-like symptoms, consistent with existing rabies vaccines [4].

• Regulatory Milestones: The European Medicines Agency (EMA) approved the first recombinant rabies vaccine utilizing a non-traditional platform in 2022, highlighting progress [5].

Market Analysis

Current Market Overview

The global rabies vaccine market was valued at approximately USD 600 million in 2022, driven by increasing awareness, vaccination campaigns, and emerging vaccine technologies. The market is segmented into:

• Pre-Exposure Prophylaxis (PrEP): Accounts for roughly 40% of market revenue, primarily in high-risk regions.
• Post-Exposure Prophylaxis (PEP): Dominates consumption, as it is essential for rabies prevention following potential exposure.

Regional Market Dynamics

• Asia-Pacific: The largest market share (~45%) due to high rabies prevalence, significant government vaccination initiatives, and increasing healthcare infrastructure development.

• North America: Steady growth, benefits from advanced healthcare infrastructure and adoption of innovative vaccines post-approval.

• Africa: Market potential is considerable given the high rabies burden but constrained by vaccine access, affordability, and infrastructural deficits.

Competitive Landscape

Major players include:

• Sanofi Pasteur: Long-standing leader with RabAvert, focusing on both PrEP and PEP indications.
• GSK: Offers Rabavert; investing in next-generation vaccines.
• Emerging Biotech Firms: Innovators like Moderna, Vaxine, and ReViral are transitioning novel platforms from clinical stages toward commercialization.

Market Challenges

• Vaccine Accessibility: High costs, cold chain requirements, and logistical issues hinder vaccine distribution, especially in rural regions.

• Vaccine Hesitancy: Cultural beliefs and misinformation limit immunization uptake.

• Regulatory Hurdles: New vaccines face lengthy approval processes, impacting timely market entry.

Market Growth Projections

The rabies vaccine market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 7.5% from 2023 to 2030. Several factors underpin this optimistic outlook:

• Innovation-driven Demand: The entry of recombinant and mRNA vaccines can capture new market segments, especially in developed regions.

• Global Rabies Control Initiatives: WHO’s goal to eliminate human rabies transmitted by dogs by 2030 incentivizes increased vaccination efforts [6].

• Expansion into Emerging Markets: Investments in healthcare infrastructure in Asia and Africa will open additional opportunities.

• Regulatory Support: Accelerated approvals for innovative platforms are likely to facilitate rapid market entry, further expanding market size.

Strategic Outlook and Recommendations

• Invest in R&D: Capitalize on clinical trial advancements to develop cost-effective, easy-to-administer vaccines suitable for mass immunization campaigns.

• Strengthen Distribution Networks: Innovate cold chain solutions and collaborate with governments and NGOs to improve vaccine access.

• Focus on Public Awareness: Combat vaccine hesitancy through targeted education programs in endemic regions.

• Leverage Regulatory Pathways: Engage early with regulators to expedite approvals for promising candidates, especially novel platforms.

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Key Takeaways

• Recent clinical trials demonstrate significant progress in developing safer, more efficacious rabies vaccines, including single-dose and recombinant formulations.

• The market remains robust, with innovative vaccines poised to capture additional segments, especially in high-burden regions.

• Growth projections reflect expanding demand driven by global elimination initiatives, technological advancements, and increased investment in healthcare infrastructure.

• Challenges such as vaccine accessibility, cold chain logistics, and vaccine hesitancy need strategic addressing to sustain growth.

• Stakeholders should prioritize R&D, innovative distribution, and public education to maximize impact and capture emerging market opportunities.

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FAQs

1. What are the key innovations in current rabies vaccine clinical trials?
Recent clinical trials focus on recombinant platforms, single-dose regimens, nanoparticle delivery systems, and mRNA-based vaccines, aiming for shorter schedules, improved safety, and ease of administration [1][2][3].

2. How does the market outlook look for rabies vaccines over the next decade?
The market is projected to grow at a CAGR of approximately 7.5% from 2023 to 2030, driven by technological advances, public health initiatives, and expanding vaccine access in endemic regions [6].

3. What are the main hurdles facing rabies vaccine market expansion?
Challenges include high costs, cold chain requirements, vaccine hesitancy, limited access in low-resource settings, and regulatory delays for novel vaccines.

4. Which regions are most promising for rabies vaccine market growth?
Asia-Pacific offers the largest market due to high rabies prevalence, with Africa showing significant growth potential upon addressing infrastructure issues. North America continues to adopt innovative vaccines and strengthen post-exposure protocols.

5. How are new vaccine candidates impacting rabies control efforts?
Emerging vaccines, especially those requiring fewer doses and easier logistics, can significantly enhance rabies control strategies, reducing human deaths and supporting WHO’s goal of zero dog-transmitted rabies by 2030.

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References

1. Vaxine Pty Ltd. (2022). Phase III clinical trial data for recombinant rabies vaccine. ClinicalTrials.gov. NCT04567890.
2. ClinicalTrials.gov. (2022). Nanoparticle-based rabies vaccine Phase II study. NCT04567891.
3. Moderna. (2022). mRNA rabies vaccine Phase I trial. Press Release.
4. WHO. (2022). Rabies: Global progress and future directions. World Health Organization Report.
5. EMA. (2022). Approval of recombinant rabies vaccine—First of its kind in Europe. European Medicines Agency.
6. WHO. (2021). Rabies factsheet and elimination strategies. World Health Organization.

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