CLINICAL TRIALS PROFILE FOR RABAVERT

All Clinical Trials for RABAVERT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03264157 ↗	Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects	Completed	Bio Products Laboratory	Phase 2/Phase 3	2017-12-08	A prospective, randomized, blinded, parallel-group, non-inferiority, phase II/III study of the safety and effectiveness of simulated post-exposure prophylaxis with BPL HRIG with co-administration of active rabies vaccine in healthy subjects.
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.
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 RABAVERT

Condition Name

Condition Name for RABAVERT
Intervention	Trials
Rabies	2
Healthy	1
Virus Diseases	1

Condition MeSH

Condition MeSH for RABAVERT
Intervention	Trials
Rabies	4
Virus Diseases	1

Clinical Trial Locations for RABAVERT

Trials by Country

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Trials by Country for RABAVERT
Location	Trials
United States	8

Trials by US State

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−

Trials by US State for RABAVERT
Location	Trials
New York	3
Maryland	1
Kansas	1
Florida	1
North Carolina	1

Clinical Trial Progress for RABAVERT

Clinical Trial Phase

Clinical Trial Phase for RABAVERT
Clinical Trial Phase	Trials
Phase 4	2
Phase 2/Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for RABAVERT
Clinical Trial Phase	Trials
Completed	3
Active, not recruiting	1

Clinical Trial Sponsors for RABAVERT

Sponsor Name

Sponsor Name for RABAVERT
Sponsor	Trials
Walter Reed Army Institute of Research (WRAIR)	2
State University of New York - Upstate Medical University	2
Kansas State University	1

Sponsor Type

Sponsor Type for RABAVERT
Sponsor	Trials
Other	4
U.S. Fed	2
Industry	1

RABAVERT: Clinical Trials, Market Analysis, and Projections

Introduction to RABAVERT

RABAVERT is a rabies vaccine developed to prevent rabies, a deadly viral disease. Here, we will delve into the clinical trials, market analysis, and future projections for this vaccine.

Clinical Trials Overview

Immunogenicity and Safety

Clinical trials for RABAVERT have demonstrated its efficacy and safety. The vaccine has been evaluated in various studies conducted in different countries, including the US, UK, Croatia, and Thailand.

• Preexposure Vaccination: Studies have shown that RABAVERT, when administered according to the recommended schedule (Days 0, 7, and 21 or 0, 7, and 28), achieves protective antibody titers in all subjects. For instance, in US studies involving 101 subjects, all attained antibody titers greater than 0.5 IU/mL by Day 28[4].

• Booster Doses: The vaccine's ability to boost previously immunized subjects has been evaluated in several trials. In a Thailand study, preexposure booster doses resulted in enhanced antibody titers from geometric mean titers (GMTs) of 1.91 to 23.66 IU/mL on Day 30[4].

• Persistence of Antibody: Long-term studies have indicated that neutralizing antibody titers remain above the protective threshold even two years after immunization. A UK trial found that all sera tested had titers greater than 0.5 IU/mL two years post-immunization[4].

Comparison with Other Vaccines

While RABAVERT has shown promising results, it is essential to compare it with other rabies vaccines. For example, the University of Oxford's new single-shot rabies vaccine, ChAdOx2 RabG, has also demonstrated strong immune responses and long-term protection, highlighting the ongoing innovation in rabies vaccine technology[1].

Market Analysis

Global Market Size and Growth

The global rabies vaccine market, which includes RABAVERT, is projected to grow significantly in the coming years.

• Current Market Size: As of 2018, the rabies vaccine market size was estimated at $635.6 million. By 2025, it is expected to reach $970 million, growing at a CAGR of 6% during the forecast period of 2019-2025[2].

• Regional Market Share: North America holds the largest market share, accounting for 30% of the revenue, primarily due to the advanced healthcare sector in this region. Other significant markets include Europe, APAC, and South America[2].

Product Segments and Key Players

• Vero Cells Rabies Vaccine: This segment has the highest revenue and market share due to its feasibility and wider application. Companies like GlaxoSmithKline (GSK) and Bharat Biotech are key players in this market. For instance, GSK's Chiron Behring Vaccines unit was divested to Bharat Biotech, enhancing their product portfolio and availability[2].

• Government Initiatives and Awareness: Growing awareness about rabies prevention and government support are driving the market growth. However, lack of resources and adequate vaccine supply in developing nations remain significant challenges[2].

Market Projections

Future Growth and Trends

• Forecasted Market Size: By 2025, the rabies vaccine market is expected to reach $970 million. The market is anticipated to continue growing, driven by increasing awareness and government initiatives[2].

• Regional Expansion: The market is expected to expand in regions like APAC and Africa, where rabies is more prevalent. Ongoing and future clinical trials, such as the Phase Ib/II trial of ChAdOx2 RabG in Tanzania, will play a crucial role in this expansion[1].

Challenges and Opportunities

• Resource Constraints: Despite the growth, the market faces challenges such as lack of resources and inadequate vaccine supply in developing countries. Addressing these issues will be crucial for further market expansion[2].

• Innovative Technologies: The development of new vaccine technologies, such as the single-shot ChAdOx2 RabG vaccine, presents opportunities for more affordable and efficient rabies vaccination programs[1].

Key Takeaways

• Clinical Efficacy: RABAVERT has demonstrated strong immunogenicity and safety in clinical trials.
• Market Growth: The global rabies vaccine market is projected to grow significantly, driven by increasing awareness and government initiatives.
• Regional Expansion: The market is expected to expand in regions with high rabies prevalence.
• Challenges: Resource constraints in developing countries remain a significant challenge.
• Opportunities: Innovative vaccine technologies offer potential for more affordable and efficient vaccination programs.

FAQs

1. What are the key findings from the clinical trials of RABAVERT?

The clinical trials of RABAVERT have shown that the vaccine achieves protective antibody titers in all subjects when administered according to the recommended schedule. It also effectively boosts antibody levels in previously immunized individuals and maintains long-term protection[4].

2. How does RABAVERT compare with other rabies vaccines in terms of market share?

RABAVERT is part of the Vero Cells Rabies vaccine segment, which has the highest revenue and market share due to its feasibility and wider application. However, new vaccines like ChAdOx2 RabG are emerging and could potentially alter market dynamics[1][2].

3. What are the main drivers of the global rabies vaccine market?

The main drivers include growing awareness about rabies prevention, government support, and increasing initiatives to eradicate rabies, especially in developing countries[2].

4. What are the challenges faced by the rabies vaccine market?

The market faces challenges such as lack of resources and inadequate vaccine supply in developing nations, which hinder market growth in these regions[2].

5. What are the future projections for the rabies vaccine market?

The market is expected to reach $970 million by 2025 and continue growing, driven by increasing awareness and government initiatives. Regional expansion, especially in APAC and Africa, is also anticipated[2].

Cited Sources

1. University of Oxford: "First clinical trial data for new rabies vaccine candidate demonstrates promising immune response and safety" - July 27, 2022.
2. IndustryARC: "Rabies Vaccine Market - Forecast(2024 - 2030)".
3. ClinicalTrialsArena: "Most significant clinical trials of 2023" - December 27, 2023.
4. FDA: "Package Insert - RabAvert" - FDA.
5. Grand View Research: "Rabies Veterinary Vaccines Market | Industry Report, 2030".