CLINICAL TRIALS PROFILE FOR ERVEBO

All Clinical Trials for ERVEBO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04822376 ↗	Prophylaxis Vaccine Antibodies Ebola	Not yet recruiting	ANRS, Emerging Infectious Diseases	Phase 2	2021-10-17	- Three measures are currently being implemented to control Ebola outbreaks: - Monitoring of contacts - Isolation and treatment of sick people - Vaccination of the population in high-risk areas. - In contacts with high viral exposure and therefore a high risk of incubation and rapid expression of infection, the r-VSV-ZEBOV vaccine does not provide adequate protection because vaccine antibody production is effective 6 to 10 days after administration. - Specific monoclonal antibodies (Mab) from the Regeneron and mAb114 research specialties have been shown to be effective in reducing mortality in patients with Ebola virus disease (EVD). - Their use in a single parenteral administration and good tolerability make them candidates for use in post-exposure prophylaxis (PEP) in individuals at high risk of viral exposure. - A comprehensive strategy for the protection of high-risk contacts must therefore be implemented, including the vaccine and the Mabs, to ensure both immediate and prolonged protection. Indeed, the efficacy of the vaccine is likely to be diminished when co-administered with Mabs, as both strategies share the same viral target (the GP envelope glycoprotein) and the vaccine is replicative (and therefore may be inhibited by Mabs). PROVAE aim to evaluate the effectiveness of a comprehensive strategy to prevent transmission of MVE in contacts at high risk of infection, including (i) post-exposure prophylaxis with Mabs and (ii) vaccination with r-VSV-ZEBOV.
NCT04990466 ↗	Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine.	Not yet recruiting	Brilife Georgia	Phase 2/Phase 3	2021-09-30	IIBR-100 (VSV-ΔG) is a self-propagating live virus vaccine that contains the spike protein of the Wuhan wild-type SARS-CoV-2 virus. Preclinical and phase 1/2 trials have demonstrated no safety signals of concern and have further demonstrated immunologic response that approximates the response seen in convalescent individuals. The purpose of this phase 2b/3 trial is to document the non-inferiority of IIBR-100 vs. an already-approved vaccine for COVID-19.
NCT04990466 ↗	Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine.	Not yet recruiting	Cromos	Phase 2/Phase 3	2021-09-30	IIBR-100 (VSV-ΔG) is a self-propagating live virus vaccine that contains the spike protein of the Wuhan wild-type SARS-CoV-2 virus. Preclinical and phase 1/2 trials have demonstrated no safety signals of concern and have further demonstrated immunologic response that approximates the response seen in convalescent individuals. The purpose of this phase 2b/3 trial is to document the non-inferiority of IIBR-100 vs. an already-approved vaccine for COVID-19.
NCT04990466 ↗	Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine.	Not yet recruiting	Iqvia Pty Ltd	Phase 2/Phase 3	2021-09-30	IIBR-100 (VSV-ΔG) is a self-propagating live virus vaccine that contains the spike protein of the Wuhan wild-type SARS-CoV-2 virus. Preclinical and phase 1/2 trials have demonstrated no safety signals of concern and have further demonstrated immunologic response that approximates the response seen in convalescent individuals. The purpose of this phase 2b/3 trial is to document the non-inferiority of IIBR-100 vs. an already-approved vaccine for COVID-19.
NCT04990466 ↗	Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine.	Not yet recruiting	Israel Institute for Biological Research	Phase 2/Phase 3	2021-09-30	IIBR-100 (VSV-ΔG) is a self-propagating live virus vaccine that contains the spike protein of the Wuhan wild-type SARS-CoV-2 virus. Preclinical and phase 1/2 trials have demonstrated no safety signals of concern and have further demonstrated immunologic response that approximates the response seen in convalescent individuals. The purpose of this phase 2b/3 trial is to document the non-inferiority of IIBR-100 vs. an already-approved vaccine for COVID-19.

Clinical Trial Conditions for ERVEBO

Condition Name

Condition Name for ERVEBO
Intervention	Trials
Ebola Virus Disease	3
COVID-19	1

Condition MeSH

Condition MeSH for ERVEBO
Intervention	Trials
Virus Diseases	3
Hemorrhagic Fever, Ebola	3
COVID-19	1

Clinical Trial Locations for ERVEBO

Trials by Country

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Trials by Country for ERVEBO
Location	Trials
Guinea	2
Congo, The Democratic Republic of the	1

Clinical Trial Progress for ERVEBO

Clinical Trial Phase

Clinical Trial Phase for ERVEBO
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for ERVEBO
Clinical Trial Phase	Trials
Not yet recruiting	4

Clinical Trial Sponsors for ERVEBO

Sponsor Name

Sponsor Name for ERVEBO
Sponsor	Trials
ANRS, Emerging Infectious Diseases	2
Alliance for International Medical Action	1
Clinical and Operational Research Alliance (CORAL)	1

Sponsor Type

Sponsor Type for ERVEBO
Sponsor	Trials
Other	14
Industry	2

ERVEBO: The Groundbreaking Ebola Vaccine

Introduction to ERVEBO

ERVEBO, developed by Merck, is the world's first approved Ebola vaccine, marking a significant milestone in the fight against the deadly Ebola virus. This vaccine has been instrumental in controlling outbreaks and protecting individuals at high risk of exposure.

Clinical Trials and Efficacy

Approval and Clinical Evidence

ERVEBO was approved by the European Commission in 2019 and later by the U.S. FDA in December 2019 for active immunization against disease caused by Zaire ebolavirus in individuals 18 years of age and older[4][5].

The efficacy of ERVEBO was established through several clinical trials, most notably the Ebola Ça Suffit trial conducted during the 2014-2016 outbreak in Guinea. This open-label, randomized cluster (ring) vaccination study involved 3,537 contacts and contacts of contacts of individuals with laboratory-confirmed Ebola virus disease (EVD). The results showed that immediate vaccination significantly reduced the incidence of EVD compared to delayed vaccination[1].

Pediatric Use

Recent clinical trials have expanded the use of ERVEBO to the pediatric population. The Phase 2, randomized, double-blind, placebo-controlled study (V920-016 or PREVAC) evaluated the safety and immunogenicity of ERVEBO in individuals 12 months of age and older. The study found non-inferior immune responses in pediatric participants compared to adults and a similar safety profile, leading to FDA approval for use in this age group[4].

Safety Profile

Clinical trials have demonstrated that ERVEBO is generally safe and well-tolerated. Common adverse events include injection site pain, arthralgia (joint pain), and arthritis (joint swelling), which are mostly mild to moderate in intensity and resolve within days to weeks. No new safety signals were observed in the pediatric study, and no participants withdrew from the study due to adverse events[1][4].

Booster Dose Studies

INOVIO has conducted a Phase 1b clinical trial using INO-4201 as a booster for individuals who previously received ERVEBO. The trial showed that INO-4201 was well-tolerated and boosted humoral responses in 100% of treated participants, indicating potential for DNA medicines as part of global medical countermeasures against infectious diseases[3].

Market Analysis

Market Size and Growth

The Ebola virus vaccine market, driven significantly by ERVEBO, is projected to experience substantial growth. In 2022, the market size was approximately USD 4.4 million and is estimated to grow at a compound annual growth rate (CAGR) of 32.6% to reach USD 71 million by 2032[2].

Market Segmentation

The market is segmented by strain type, with the vesicular stomatitis virus (rVSV) segment, which includes ERVEBO, accounting for 53.9% of the market share in 2022. This segment is expected to witness robust growth due to the established safety profile and advantages of the rVSV strain, such as rapid production capabilities and single-dose administration[2].

End-Use Segmentation

The end-use categories include hospitals, clinics, and ambulatory surgical centers. Hospitals accounted for the largest market revenue in 2022, driven by the availability of skilled medical professionals and advanced healthcare infrastructure. This segment is expected to continue driving market growth due to the convenience and accessibility it offers for vaccination[2].

Regional Market

The U.S. Ebola virus vaccine market accounted for over 52.3% of the market share in 2022 and is anticipated to grow significantly. Factors contributing to this growth include the increasing prevalence of zoonotic diseases, advanced healthcare infrastructure, and rising government investments in preventive healthcare and outbreak control[2].

Market Projections

Growing Incidence of Zoonotic Diseases

The increasing incidence of zoonotic diseases globally is a key driver for the Ebola virus vaccine market. According to the World Health Organization (WHO), around 60% of known infectious diseases and over 75% of emerging infectious diseases are zoonotic in origin, which is expected to boost market progression[2].

Public Health Initiatives

Public health initiatives to prevent and control Ebola outbreaks have led to increased investments in vaccine development and procurement. This trend is expected to continue, fostering market growth as more countries and organizations invest in Ebola vaccine research and distribution[2].

Technological Advancements

Advancements in vaccine technology, such as the use of viral vectors like rVSV, have improved the efficacy and safety of Ebola vaccines. These technological advancements are expected to further drive the market as they offer rapid production capabilities and scalable solutions[2].

Key Players and Strategies

Major market players in the Ebola virus vaccine industry include Merck, INOVIO, and Johnson & Johnson, among others. These companies adopt various strategies such as collaborations, acquisitions, mergers, and partnerships to sustain market competition and expand their global footprint[2].

Conclusion

ERVEBO has revolutionized the fight against Ebola, offering a safe and effective vaccine that has been instrumental in controlling outbreaks. With ongoing clinical trials expanding its use to pediatric populations and booster dose studies, ERVEBO continues to be a cornerstone in Ebola prevention.

Key Takeaways

• Clinical Efficacy: ERVEBO has been proven effective in preventing EVD through multiple clinical trials.
• Safety Profile: The vaccine is generally safe and well-tolerated, with common adverse events being mild to moderate.
• Market Growth: The Ebola virus vaccine market is projected to grow significantly, driven by the increasing incidence of zoonotic diseases and public health initiatives.
• Technological Advancements: The use of rVSV as a vector has improved vaccine efficacy and safety.
• Public Health Impact: ERVEBO has been crucial in controlling Ebola outbreaks, particularly in regions like the Democratic Republic of Congo.

FAQs

What is ERVEBO and how does it work?

ERVEBO is a replication-competent, live, attenuated recombinant vesicular stomatitis virus (rVSV) vaccine that contains the gene for the Zaire ebolavirus Kikwit strain glycoprotein. It works by triggering an immune response in vaccinated individuals to prevent EVD.

Who is eligible to receive ERVEBO?

ERVEBO is approved for individuals 12 months of age and older who are at risk of exposure to Zaire ebolavirus. This includes healthcare workers, laboratory personnel, and others with occupational exposure risks.

What are the common side effects of ERVEBO?

Common side effects include injection site pain, arthralgia (joint pain), and arthritis (joint swelling), which are mostly mild to moderate in intensity.

How effective is ERVEBO in preventing Ebola?

ERVEBO has been shown to be highly effective in preventing EVD, with clinical trials demonstrating significant reduction in the incidence of EVD among vaccinated individuals.

Is ERVEBO available globally?

While ERVEBO is approved in several regions, including Europe and the U.S., its availability can vary globally. It is often used under compassionate use programs in areas with active Ebola outbreaks.

Sources

1. CDC: Ervebo® (Ebola Zaire Vaccine, Live) Booster Dose for Individuals with Prior Ebola Vaccination History[1].
2. Global Market Insights: Ebola Virus Vaccine Market Size – Analysis Report, 2032[2].
3. INOVIO: INOVIO Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights[3].
4. FDA: Clinical Review Memo - ERVEBO[4].
5. BioSpace: Merck's Ervebo is the World's First Approved Ebola Vaccine[5].