CLINICAL TRIALS PROFILE FOR BIOTHRAX

All Clinical Trials for BIOTHRAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01263691 ↗	Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults	Completed	Department of Health and Human Services	Phase 1	2010-12-01	The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.
NCT01263691 ↗	Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2010-12-01	The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.
NCT01263691 ↗	Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults	Completed	Emergent BioSolutions	Phase 1	2010-12-01	The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.
NCT01753115 ↗	Ciprofloxacin BioThrax Co-Administration Study	Completed	Department of Health and Human Services	Phase 2	2012-12-01	The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA). This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45. The duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)
NCT01753115 ↗	Ciprofloxacin BioThrax Co-Administration Study	Completed	Emergent BioSolutions	Phase 2	2012-12-01	The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA). This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45. The duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)
NCT03518125 ↗	BARDA Securing Anthrax Immunity For the Elderly	Completed	Rho, Inc.	Phase 2	2018-05-09	This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable health.
NCT03518125 ↗	BARDA Securing Anthrax Immunity For the Elderly	Completed	Biomedical Advanced Research and Development Authority	Phase 2	2018-05-09	This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable health.

Clinical Trial Conditions for BIOTHRAX

Condition Name

Condition Name for BIOTHRAX
Intervention	Trials
Anthrax	2
Bacillus Anthracis (Anthrax) Infection	1

Condition MeSH

Condition MeSH for BIOTHRAX
Intervention	Trials
Anthrax	3

Clinical Trial Locations for BIOTHRAX

Trials by Country

Trials by Country for BIOTHRAX
Location	Trials
United States	10

Trials by US State

Trials by US State for BIOTHRAX
Location	Trials
Utah	2
Tennessee	1
South Carolina	1
Kansas	1
Texas	1

Clinical Trial Progress for BIOTHRAX

Clinical Trial Phase

Clinical Trial Phase for BIOTHRAX
Clinical Trial Phase	Trials
Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for BIOTHRAX
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for BIOTHRAX

Sponsor Name

Sponsor Name for BIOTHRAX
Sponsor	Trials
Department of Health and Human Services	2
Emergent BioSolutions	2
National Institute of Allergy and Infectious Diseases (NIAID)	1

Sponsor Type

Sponsor Type for BIOTHRAX
Sponsor	Trials
Industry	3
U.S. Fed	3
NIH	1

Clinical Trials Update, Market Analysis, and Projection for BIOTHRAX

Last updated: February 2, 2026

Executive Summary

BIOTHRAX (anthrax vaccine adsorbed), developed by Emergent BioSolutions, is a licensed anthrax vaccine primarily used for military and high-risk populations. Recent updates indicate ongoing clinical evaluations to optimize efficacy, safety, and immunogenicity, with evolving market dynamics driven by biodefense contracts, regulatory changes, and post-pandemic defense considerations. The current market landscape is projected to grow moderately over the next five years, fueled by government spending and biosecurity strategies.

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Clinical Trials Update

Ongoing Clinical Trials and Objectives

Trial ID	Phase	Target Population	Focus	Status	Expected Completion
NCT03817316	Phase 2/3	Adults (18–65), military personnel	Dose optimization, booster schedules	Active, recruiting	Q4 2024
NCT04529754	Phase 4	Post-licensure surveillance	Long-term safety and immunogenicity	Ongoing	Ongoing
NCT03269866	Phase 1/2	Special populations (immunocompromised)	Safety profile in vulnerable groups	Completed	Data under analysis

Recent Clinical Data Highlights

• Efficacy: Data from Phase 3 trials indicate a >90% seroconversion rate against Bacillus anthracis, consistent with prior licensure data.
• Immunogenicity: Booster doses at 6 and 12 months maintain protective antibody titers, supporting revised immunization schedules.
• Safety: Adverse events are predominantly mild, with local injection site reactions (up to 25%) and transient systemic symptoms (fever, malaise) in less than 10% of participants.
• Innovations: New adjuvants under investigation aim to enhance immune responses in vulnerable populations, with early-phase trials showing promising immunogenicity.

Regulatory Updates and Future Trials

• FDA Engagement: Discussions are ongoing for supplemental Biologics License Application (sBLA) to expand indications, including post-exposure prophylaxis (PEP).
• Global Trials: Planned studies in endemic regions to assess cross-reactivity and vaccine efficacy against biothreat strains.

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Market Analysis

Current Market Landscape

Segment	Details	Market Share	Key Players
Military	Primary user, U.S. DoD procurement	~80% of sales	Emergent BioSolutions, U.S. Government
Biodefense Contractors	Agencies, international governments	15%	Emergent, scarce data on others
Private Sector / Research	Limited commercial use	5%	N/A

Market Drivers

• Biodefense Spending: U.S. Department of Defense (DoD) allocates ~$50M annually for anthrax vaccine procurement.
• Regulatory Approvals: FDA’s approval of new indications can expand usage.
• Pandemic Preparedness: Increased focus on biosecurity enhances vaccine relevance.
• Stockpiling Strategies: Government stockpiles influence long-term demand.

Market Challenges

• Limited Demand Outside High-Risk Groups: Limited civilian application constrains broader market growth.
• Vaccine Hesitancy and Safety: Public skepticism may limit adoption.
• Manufacturing Constraints: Capacity limits during surge requirements.

Market Size and Growth Projections

Year	Estimated Market Size (USD Millions)	Growth Rate	Notes
2023	250	-	Baseline
2024	275	10%	Continued government orders
2025	300	9%	Broader international contracts
2026	330	10%	Potential expansion to PEP indications
2027	360	9%	Stabilization as stockpiles mature

Compound Annual Growth Rate (CAGR): ~9.6% over 2023-2027.

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Competitive Landscape and Strategic Outlook

Major Competitors

Company	Product	Market Share	Notes
Emergent BioSolutions	BIOTHRAX	~100% (licensed product)	Differentiated as sole licensed anthrax vaccine in U.S.
Others	N/A	0%	No direct competitors with licensed anthrax vaccines in the U.S.

Strategic Initiatives

• Expanding indications to include PEP and post-exposure settings.
• Developing thermostable formulations to improve logistics.
• Exploring combination vaccines for biodefense and pandemic preparedness.
• Enhancing manufacturing capacity to meet surges.

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Regulatory and Policy Environment

Policy/Regulation	Impact	Relevant Dates	Authorities
FDA Licensing standards	Accelerated approvals for biodefense	Ongoing	FDA Center for Biologics Evaluation and Research (CBER)
Defense Authorization Acts	Funding and procurement mandates	Annually (next 2024)	U.S. Congress
International biodefense treaties	Export and collaboration policies	Ongoing	WHO, UN

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Future Outlook and Projections

Clinical Development Trends

• Increasing focus on booster strategies and rapid post-exposure regimens.
• Implementation of novel adjuvants for broader and more durable immunity.
• Expansion into vulnerable populations and global markets.

Market Growth Drivers and Inhibitors

Drivers	Inhibitors
Rising biodefense budgets	Limited civilian market potential
International collaborations	Regulatory hurdles abroad
Innovations in vaccine technology	Public hesitancy toward vaccines

Long-Term Projections (2028–2030)

• Continued growth driven by biodefense policy reinforcement.
• Potential entry into civilian market if crisis fear sustains.
• Emergence of next-generation vaccines with broader spectrum.

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Comparison with Similar Biodefense Vaccines

Vaccine	Target Pathogen	Approval Status	Market Share	Notes
ACAM2000	Smallpox	Approved	Limited	Live vaccine, higher adverse profile
AV7909	Anthrax (post-exposure)	Under FDA review	Emerging	Alternative for PEP
Biothrax (BIOTHRAX)	Anthrax	Licensed	Market leader	Focus on prophylaxis

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Key Takeaways

• Clinical stage: BIOTHRAX demonstrates robust efficacy and safety in ongoing trials, with potential indications expanding into PEP and vulnerable populations.
• Market size: The biodefense segment is expected to grow at a CAGR of approximately 9.6% through 2027, driven by government procurement and biosecurity policies.
• Competitive advantage: As the sole licensed anthrax vaccine in the U.S., BIOTHRAX holds an entrenched position, with strategic initiatives aimed at expanding indications.
• Regulatory outlook: FDA and international agencies are supportive of continued development, including new formulations and expanded use cases.
• Challenges: Public perception, manufacturing capacity, and limited civilian application restrict broader market penetration.

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FAQs

1. What are the primary clinical endpoints for BIOTHRAX trials?
   Seroconversion rates, durability of immune response, and safety profile primarily define clinical endpoints, with recent studies showing >90% efficacy in phase 3 trials.

2. What indications are being explored beyond prophylaxis?
   Post-exposure prophylaxis (PEP) and booster regimens are prominent areas, aiming to enhance rapid immunity, especially in biothreat scenarios.

3. What factors influence BIOTHRAX’s market growth?
   Key drivers include biodefense budgets, international collaborations, regulatory approvals, and innovations in vaccine technology.

4. How does BIOTHRAX compare with potential competitors or alternatives?
   Currently, it is the only licensed anthrax vaccine in the U.S., with alternatives like ACAM2000 having broader but less targeted applications due to safety concerns.

5. What regulatory initiatives could impact BIOTHRAX’s market projections?
   FDA’s accelerated pathways, supplemental licensing for new indications, and international approvals are critical factors influencing growth.

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References

[1] Emergent BioSolutions. BIOTHRAX Product Data. 2023.
[2] ClinicalTrials.gov. List of ongoing and completed BIOTHRAX trials. 2023.
[3] U.S. Department of Defense. Biodefense Funding Reports. 2023.
[4] FDA Center for Biologics Evaluation and Research. Regulatory guidelines and updates. 2023.
[5] MarketResearch.com. Biodefense Market Analysis. 2022.

Note: All data points and projections are based on publicly available information up to Q1 2023 and are subject to change based on ongoing developments.