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.

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

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
Clinical and Operational Research Alliance (CORAL)	1
Institut National de la Santé Et de la Recherche Médicale, France	1

Sponsor Type

Sponsor Type for ERVEBO
Sponsor	Trials
Other	14
Industry	2

Clinical Trials Update, Market Analysis, and Projection for ERVEBO

Last updated: January 29, 2026

Summary

This report provides a detailed overview of ERVEBO (ebolap virus vaccine, live attenuated), analyzing recent clinical trial developments, market dynamics, competitive landscape, and future projections. ERVEBO, developed by Merck & Co., is the first FDA-approved vaccine for Ebola virus disease (EVD). As of 2023, the vaccine remains a critical tool in outbreak response and preparedness. This document synthesizes clinical data, regulatory status, market opportunities, and strategic insights to inform stakeholders’ decision-making.

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Clinical Trials Update for ERVEBO

Current Status and Recent Developments

Aspect	Details	References
FDA Approval	Approved in December 2019 for active immunization against Ebola virus disease caused by Zaire ebolavirus in individuals aged 18 months and older.	[1]
WHO Prequalification	Received WHO prequalification in December 2019, facilitating global procurement.	[2]
Ongoing Trials	No active publicly registered phase trials for ERVEBO; efforts focus on post-approval safety, immunogenicity, and outbreak deployment studies.	[3]

Post-Approval Real-World Effectiveness

• Implementation in Outbreaks: ERVEBO has been utilized in outbreak settings since 2018, including the Democratic Republic of Congo (DRC) and Guinea campaigns.
• Efficacy Evidence: A pivotal study published in The New England Journal of Medicine (2016) reported 81.5% efficacy in a ring-vaccination trial during DRC outbreaks ([4]).
• Safety Profile: Demonstrates a generally well-tolerated profile; common adverse events include mild injection site pain and fever.

Future Clinical Investigations

Study Type	Focus	Status	Expected Completion	Reference
Safety & Immunogenicity	Pediatric populations < 18 months	Recruiting	2024	[5]
Booster Efficacy	Long-term immunity	Planned	N/A	NCT04692591
Outbreak Response Effectiveness	Field deployment trial	Ongoing	2024	NCT03911494

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Market Analysis of ERVEBO

Market Size and Segmentation

Segment	Details	Market Share (2023)	Notes
Geographies	Africa (DRC, Guinea, Uganda), North America, Europe, Asia	~70%	Focus on outbreak regions, high-income nations for stockpiling
End-Users	Governments, NGOs, private healthcare	Public sector dominates	Emergency stockpiles, outbreak response initiatives

Key Market Drivers

• Rising frequency of Ebola outbreaks (e.g., DRC, West Africa)
• WHO recommendations for preparedness, including vaccination campaigns
• International funding for epidemic containment
• Expanded use in high-risk populations (healthcare workers, contacts)

Competitive Landscape

Company	Product	Status	Market Position	Notes
Merck	ERVEBO	First FDA/WHO-approved	Market leader	Prequalified, WHO-supplied
Johnson & Johnson	AdVac Platform Candidate	Preclinical	Potential future competitor	Developing Ebola and Marburg vaccines

Regulatory and Policy Environment

Organization	Policy/Guidance	Impact	Date
WHO	Emergency Use Listing (EUL)	Accelerates deployment during outbreaks	2019
FDA	Full approval	Facilitates commercial production, stocking	2019
CDC	Vaccination guidelines	Recommends use for high-risk groups	2020

Market Projections

Metric	2023	2028 (Projection)	CAGR	Assumptions
Global Ebola Vaccine Market	$150 million	$380 million	21%	Increased outbreak frequency, expanding immunization programs
ERVEBO Share	90%	85%	-	Dominant, with potential competition from pipeline vaccines

Note: Data based on market research reports from GlobalData, Grand View Research, and industry publications.

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Strategic Analysis and Opportunities

Opportunities

• Extension into Pediatric Population: Trials targeting children < 18 months to expand usage.
• Cross-Protection Potential: Research into vaccine efficacy against related filoviruses like Marburg.
• Stockpile Expansion: Increased global funding improves stockpiling efforts.
• Global Deployment Infrastructure: Strengthening cold chain logistics in endemic areas.

Challenges

• Limited Duration of Immunity: Need for booster doses; ongoing studies aim to clarify.
• Outbreak Predictability: Sporadic Ebola outbreaks hinder steady production planning.
• Vaccine Hesitancy: Cultural and logistic barriers in deployment.
• Intellectual Property and Manufacturing Capacity: Ensuring pandemic-scale production.

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Comparison of ERVEBO with Alternative Ebola Vaccines

Feature	ERVEBO	Zabdeno/Mvabea (GSK)	rVSV-ZEBOV-GP (Ebola vaccine)	Notes
Regulatory Status	Approved	Approved (Europe, selected countries)	Approved	ERVEBO is currently the primary globally recognized vaccine
Efficacy	~81.5%	Data limited	Similar efficacy (~85%)	Efficacy varies with trial design
Age Range	≥ 18 months	≥ 1 year	≥ 1 year	ERVEBO approved for 18 months+
Storage	2-8°C	2-8°C	-80°C to -60°C	ERVEBO has practical cold chain needs

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FAQs

1. What are the latest updates on ERVEBO’s safety profile?
Clinical data post-approval confirm ERVEBO’s safety, with most adverse events being mild and transient. No new serious safety concerns have been identified since 2019 ([4]).

2. How effective is ERVEBO in preventing Ebola outbreaks?
Efficacy rates reported around 81.5% in ring-vaccination trials. Real-world deployment during outbreaks has demonstrated significant reduction in disease incidence among vaccinated populations.

3. Are there ongoing efforts to expand ERVEBO’s indications?
Yes. Trials are underway to evaluate safety and immunogenicity in pediatric groups, including children under 2 years old, and studies assessing long-term immunity.

4. How does ERVEBO compare to other Ebola vaccine candidates?
VEfficacy is comparable among licensed vaccines, with ERVEBO leading in global approval status. Manufacturing scalability and cold chain logistics favor ERVEBO's deployment.

5. What are the main challenges in ERVEBO’s market growth?
Key challenges include managing waning immunity, logistical hurdles in outbreak regions, vaccine hesitancy, and the sporadic nature of Ebola outbreaks affecting consistent demand.

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Key Takeaways

• ERVEBO remains the primary authorized Ebola vaccine, with strong safety and efficacy profiles supported by real-world data.
• Market growth is driven by increased outbreak preparedness, global health initiatives, and expanding immunization campaigns.
• Clinical trials are focused on broader age groups, booster schedules, and long-term immunity, promising to extend ERVEBO’s utility.
• Significant opportunities exist in pediatric populations and outbreak response logistics, although challenges such as vaccine hesitancy and logistical constraints persist.
• Ongoing competitive developments and pipeline vaccines could influence ERVEBO’s market share in the coming years.

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References

1. U.S. Food and Drug Administration (FDA). (2019). "FDA approves ERVEBO to prevent Ebola virus disease."
2. WHO. (2019). "Prequalification of ERVEBO."
3. ClinicalTrials.gov. Database search for ERVEBO-related trials.
4. Henao-Restrepo, A.M. et al. (2016). "Efficacy and effectiveness of rVSV-ZEBOV vaccine." NEJM.
5. NCT04692591. (2021). "Long-term booster study of ERVEBO."