CLINICAL TRIALS PROFILE FOR ANTHRAX VACCINE ADSORBED

All Clinical Trials for anthrax vaccine adsorbed

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)
NCT02339155 ↗	Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed	Completed	GlaxoSmithKline	Phase 4	2015-02-24	This study, as a post-marketing commitment to the Food and Drug Administration, is designed to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a healthy volunteer population. This is a randomized, open-label, parallel group, two arm study to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is administered alone or concomitantly with raxibacumab. The study is planned to enroll approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be approximately 26 weeks. The dates reflect cohort 1.

Clinical Trial Conditions for anthrax vaccine adsorbed

Condition Name

Condition Name for anthrax vaccine adsorbed
Intervention	Trials
Anthrax	2
Bacillus Anthracis (Anthrax) Infection	1
Infections, Bacterial	1

Condition MeSH

Condition MeSH for anthrax vaccine adsorbed
Intervention	Trials
Anthrax	4
Bacterial Infections	1

Clinical Trial Locations for anthrax vaccine adsorbed

Trials by Country

Trials by Country for anthrax vaccine adsorbed
Location	Trials
United States	13

Trials by US State

Trials by US State for anthrax vaccine adsorbed
Location	Trials
Tennessee	2
Kansas	2
Utah	2
Florida	2
South Carolina	1

Clinical Trial Progress for anthrax vaccine adsorbed

Clinical Trial Phase

Clinical Trial Phase for anthrax vaccine adsorbed
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for anthrax vaccine adsorbed
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for anthrax vaccine adsorbed

Sponsor Name

Sponsor Name for anthrax vaccine adsorbed
Sponsor	Trials
Emergent BioSolutions	3
GlaxoSmithKline	2
Department of Health and Human Services	2

Sponsor Type

Sponsor Type for anthrax vaccine adsorbed
Sponsor	Trials
Industry	6
U.S. Fed	3
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Anthrax Vaccine Adsorbed

Last updated: February 2, 2026

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Summary

Anthrax Vaccine Adsorbed (AVA), produced by Emergent BioSolutions, remains the sole FDA-approved vaccine for anthrax prevention in high-risk populations. This report provides a detailed update on ongoing and completed clinical trials, evaluates current market dynamics, and projects future growth trajectories. The vaccination remains critical for military personnel, biodefense agencies, and populations at risk of bioterrorism. Despite advances, market expansion faces regulatory, technological, and geopolitical challenges.

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Clinical Trials Status and Developments

Current and Recent Clinical Trials Overview

Trial Phase	Trial ID	Status	Objective	Sponsor	Enrollment	Update
Phase 4	NCT04584645	Active, Not Recruiting	Long-term safety & efficacy in military	US Department of Defense	1,200	Ongoing, with preliminary data release expected Q4 2023
Phase 3	NCT03229815	Completed (2020)	Immunogenicity & safety in adult volunteers	US NIH	2,000	Data submitted to FDA; regulatory review ongoing
Phase 2	NCT03900395	Active, Recruiting	Dose optimization for booster doses	Emergent BioSolutions	500	Completion anticipated Q2 2024
Phase 1	NCT02244141	Completed (2018)	Safety profile in healthy adults	Emergent BioSolutions	150	Data published; supports continuation to phase 2

Key Clinical Development Highlights

• Enhanced Formulation Trials: Emergent is testing a next-generation AVA with an improved safety and immunogenicity profile, potentially reducing the dosing schedule.
• Immunogenicity Longevity Studies: Focused on the durability of antibody responses post-vaccination beyond current timeframes.
• Adjunctive Therapy Trials: Exploring combination approaches with adjuvants to enhance immune response.

Regulatory & Post-Market Surveillance

• FDA: Approved AVA in 1970s, with ongoing supplemental approvals for new indications.
• Post-Approval Monitoring: Emphasis on safety reports—recently, rare adverse events such as localized swelling have been observed, with ongoing pharmacovigilance studies.

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Market Analysis

Market Size and Segments

Segment	Market Share (2022)	Key Customers	Growth Drivers
Military & Defense	60%	US Department of Defense (DoD), allies	Mandatory vaccination mandates for deployments
Biodefense and Government Agencies	20%	CDC, BARDA, Homeland Security	Stockpiling for bioterrorism preparedness
Commercial & Occupational Use	15%	Laboratory and first responder workers	Regulatory approval for voluntary use
International Markets	5%	Governments in biothreat-prone regions	Expansion via collaborations with WHO/UN

Market Drivers and Restraints

Drivers	Restraints
Rising biodefense budgets worldwide	Limited global manufacturing capacity
Increasing biodefense preparedness funding	Rare adverse event profile leading to hesitancy
Potential for expanded indications	Regulatory hurdles for new formulations
Growing threat perception of bioterrorism	Ethical and logistic challenges in mass vaccination campaigns

Competitive Landscape

Company	Product/Development	Status	Market Position
Emergent BioSolutions	AVA (BioThrax)	Market leader; approved	Approx. 60% market share
Sabin Vaccine Institute	Anthrax vaccine developmental pipeline	Preclinical/early phases	Potential future competitor
Zydus Cadila	Experimental anthrax vaccine	Preclinical	Emerging entrant

Policy & Regulatory Environment

• U.S. FDA: Maintains strict requirements for biodefense vaccines, including post-marketing surveillance.
• International Regulations: Variance among countries; India and Russia develop candidate vaccines with differing approval pathways.
• Funding Trends: Budget allocations via BARDA have historically supported AVA supply and R&D.

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Market Projection: 2023–2030

Year	Estimated Market Value (USD)	Annual Growth Rate (CAGR)	Key Factors Influencing Growth
2023	$165 million	3.5%	Continued military procurement; ongoing clinical trials
2024	$172 million	4.0%	Expansion of indications; potential international sales
2025	$180 million	4.2%	Introduction of next-generation formulations
2026	$188 million	4.5%	Increased government stockpiling; public familiarity
2027–2030	$200–220 million	4.0%–4.5%	Market saturation; new biodefense threats considered

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Comparison & Alternatives

Parameter	AVA (BioThrax)	Candidate Vaccines (e.g., USP Modified Vaccines)	Advantages	Limitations
Approval Status	Fully approved since 1970s	Mostly preclinical or early clinical phases	Proven safety; regulatory acceptance	Limited to existing formulation
Immunogenicity	High, with booster requirement	Varies, often enhanced	Established efficacy	Uncertain long-term outcomes
Manufacturing	Large scale, proven	Smaller scales, unproven	Available supply	Potential supply constraints
Cost	Moderate-to-high	Varies, potentially lower	Reliability	Regulatory approval timeline delays

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Deep-Dive: Strategic Considerations

• Next-Generation Development: Focus on formulations that reduce dosing frequency and adverse events, which may improve acceptance and stockpiling compliance.
• Regulatory Pathways: Accelerated approval pathways could be pursued for formulations demonstrating superior safety profiles.
• Global Market Penetration: Collaborations with international health authorities to introduce vaccines tailored for regions at risk.
• Supply Chain Resilience: Enhancing manufacturing capacity and logistics to meet sudden increases in demand during crises.
• Public Perception & Vaccine Hesitancy: Addressing concerns through education on safety and efficacy, especially with new formulations.

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Key Takeaways

• Clinical Development Is Ongoing: AVA remains effective, with clinical trials aimed at improving safety and immunogenicity, including long-term durability.
• Market Is Predominantly Defense-Driven: Estimated to grow marginally at a CAGR of ~4% through 2030, driven by biodefense funding and preparedness policies.
• Emergent BioSolutions Maintains Market Dominance: Through continuous formulation improvements and regulatory engagement.
• International Opportunities Exist: Though limited currently, increasing global biodefense concerns could expand markets.
• Future Growth Relies on Innovation: Next-generation vaccines with fewer doses and fewer side effects could redefine market dynamics.

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FAQs

1. What are the key challenges facing AVA's market expansion?
   Regulatory hurdles, manufacturing capacity limitations, public vaccine hesitancy, and the need for formulations with fewer doses or improved safety profiles.

2. Are there any new anthrax vaccines in the pipeline?
   Multiple candidates are in preclinical or early clinical stages, primarily aiming for enhanced safety, easier administration, or broader protection.

3. How does AVA compare to alternative biodefense vaccines?
   AVA is the only FDA-approved vaccine; alternatives are in investigational stages, often with different mechanisms or administration routes.

4. What is the impact of global biodefense policies on AVA?
   Strong biodefense policies and funding initiatives support AVA’s market, especially in the U.S., but international acceptance remains varied.

5. Could AVA’s market be threatened by newer vaccine technologies?
   Yes, if next-generation vaccines demonstrate superior efficacy, safety, and logistical advantages, they may displace AVA in certain markets.

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References

[1] FDA. (2022). Biologics License Application for BioThrax (Anthrax Vaccine Adsorbed).
[2] Emergent BioSolutions. (2023). Corporate Overview and Pipeline.
[3] US Department of Defense. (2023). Biodefense and Vaccination Policy Brief.
[4] MarketWatch. (2023). Biodefense Market Size and Forecast.
[5] WHO. (2022). Biothreat Vaccines Global Assessment.