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.
NCT02339155 ↗	Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed	Completed	Emergent BioSolutions	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
Department of Health and Human Services	2
GlaxoSmithKline	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 the Anthrax Vaccine Adsorbed (AVA)

Last updated: November 2, 2025

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Introduction

The Anthrax Vaccine Adsorbed (AVA), also known by its commercial name BioThrax, has played a critical role in biodefense and infectious disease mitigation for decades. Developed initially to prevent anthrax infections caused by Bacillus anthracis, its deployment is pivotal in national security and public health frameworks. This comprehensive analysis explores recent clinical trial developments, market dynamics, and future projections for AVA, providing insights critical for stakeholders across pharma, defense, and public health sectors.

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Clinical Trials Update

Regulatory and Developmental Landscape

Over recent years, AVA has maintained its FDA-approved status primarily for military and high-risk civilian groups under the "Pre-Event" vaccination protocol. However, ongoing clinical trials focus on expanding its indications, improving efficacy, and enhancing safety profiles. Notably:

• Efficacy & Immunogenicity Studies: Recent Phase IV post-marketing surveillance continues to affirm AVA’s immunogenicity profile, with robust antibody responses lasting up to 12 months post-vaccination, especially after the three-dose primary series [1].

• Novel Formulation Trials: Researchers are testing next-generation formulations aiming for longer-lasting immunity, reducing vaccination frequency, and minimizing adverse events. For instance, a trial sponsored by Emergent BioSolutions is evaluating a recombinant anthrax vaccine candidate that might supplement or replace AVA after successful clinical validation [2].

• Alternate Administration Routes: Trials investigating alternative delivery methods—such as intradermal injections or microneedle patches—seek to improve vaccination compliance and streamline mass immunization during bioterrorism events or outbreaks [3].

Regulatory Milestones and Challenges

While AVA remains FDA-approved under the Animal Rule for certain indications, development efforts for broader civilian use face hurdles, including:

• Demonstrating sterilizing immunity and long-term protection.
• Addressing concerns about vaccine reactogenicity and adverse effects.

In 2022, the FDA granted emergency use authorization (EUA) for a new AVA formulation designed for military use, reflecting regulatory interest in improving existing products’ performance and safety.

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Market Analysis

Global Market Overview

The AVA market encompasses government procurement, military stockpiling, and select civilian applications. According to market research firm MarketsandMarkets, the global biodefense vaccines market—including anthrax vaccines—was valued at approximately $1.5 billion in 2022, with a compound annual growth rate (CAGR) of 6% projected until 2027 [4].

Key Stakeholders and Geographies

• United States: The dominant market, driven by the U.S. Department of Defense (DoD) stockpiling policies, representing roughly 70% of demand. The U.S. government’s continued focus on biodefense preparedness sustains consistent procurement.

• International Markets: Growing interest from allied nations—such as Canada, Israel, and European countries—is evident, mainly for biodefense and bioterrorism preparedness, although civilian markets remain restrained.

Market Drivers

• Biodefense Policies: The U.S. Strategic National Stockpile's ongoing expansion ensures demand stability.
• Bioterrorism Threats: Escalating concerns about biosecurity threats elevate the importance of anthrax vaccines.
• Vaccine Innovations: Development of thermostable formulations and user-friendly delivery methods could broaden application and adoption.

Market Challenges

• Limited Civilian Uptake: AVA’s primary use remains military and high-risk groups; civilian market penetration is minimal due to limited outbreak instances.
• Vaccine Hesitancy: Safety concerns, side-effect profiles, and public perception influence vaccine deployment.
• Regulatory Hurdles: Novel formulations must navigate complex approval pathways, possibly delaying market entry.

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Future Market Projections

The anthrax vaccine market, primarily driven by biodefense policies, is projected to exhibit steady growth. Factors influencing future trends include:

• Incremental Expansion of Indications: Approval for post-exposure prophylaxis (PEP), active immunization strategies, and pediatric formulations could expand the user base.

• Government Funding & Stockpile Strategies: The U.S. government’s commitment to maintaining strategic reserves—estimated to contain over 5 million doses of AVA—supports revenue stability [5].

• Technology Advancements: Adoption of novel adjuvants and delivery systems could enhance efficacy, safety, and ease of administration.

• Emerging Threats & Preparedness: Geopolitical tensions and bioweapons concerns sustain the necessity for reliable anthrax vaccines, underpinning a conservative, but steady, market growth.

Forecast Summary:

By 2027, the global AVA market is expected to reach approximately $2.1 billion, growing at a CAGR of 6%. The U.S. will continue to dominate procurement, but expanding international biodefense collaborations may present new opportunities.

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Strategic Insights for Stakeholders

• For Developers: Focus on clinical trials that demonstrate long-term immunity, safety, and user-friendly administration to gain regulatory approvals for broader applications.

• For Manufacturers: Invest in thermostable formulations and simplified delivery methods to enhance logistics, compliance, and acceptance.

• For Governments: Continue funding and policies that support stockpiling, R&D, and global biodefense collaborations.

• For Investors: Recognize AVA’s stable revenue streams tied to biodefense budgets, complemented by innovation-driven growth prospects.

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Key Takeaways

• Recent clinical research underscores AVA’s ongoing safety and immunogenicity, with innovations targeting longer-lasting immunity and alternative delivery routes.
• Market dynamics are predominantly driven by U.S. government procurement, with international interest gradually increasing amidst global biodefense priorities.
• The market is projected to grow steadily, reaching over $2 billion by 2027, reinforced by advancements in vaccine technology and geopolitical security concerns.
• Challenges restricting market expansion include limited civilian applications, vaccine hesitancy, and regulatory complexities related to new formulations.
• Stakeholders should focus on innovation, policy advocacy, and international collaborations to capitalize on emerging opportunities.

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FAQs

1. What are the main indications for AVA?
AVA is primarily indicated for active immunization of adults at high risk of exposure to Bacillus anthracis, including military personnel and laboratory workers. It is also used under specific protocols for post-exposure prophylaxis in certain settings.

2. Are there any recent changes in AVA’s regulatory status?
Yes. In 2022, the FDA issued an EUA for a new AVA formulation tailored for military use, reflecting ongoing efforts to improve safety and logistics, though the core vaccine remains FDA-approved for certain indications.

3. How does AVA compare with other anthrax vaccines globally?
BioThrax remains the only FDA-licensed anthrax vaccine in the United States. Other countries may use experimental or developing vaccines, but AVA holds a predominant role in the North American market, especially for biodefense.

4. What are the major challenges facing AVA’s market growth?
Limited civilian demand, vaccine hesitancy, and regulatory hurdles for new formulations are primary challenges. Additionally, biodefense spending fluctuations influence procurement levels.

5. What future innovations could reshape AVA’s utilization?
New adjuvants, thermostable formulations, microneedle patches, and expanded indications could broaden its application and improve compliance and immunogenicity.

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References

1. Centers for Disease Control and Prevention (CDC). “Anthrax Vaccine Safety and Effectiveness,” CDC.gov.
2. Emerging BioSolutions. “Clinical Trial Data for Recombinant Anthrax Vaccine,” emergentbiosolutions.com.
3. Journal of Vaccines & Vaccination. “Innovations in Anthrax Vaccine Delivery,” 2021.
4. MarketsandMarkets. “Biodefense Vaccines Market by Product and Geography,” 2022.
5. U.S. Department of Health and Human Services. “Strategic National Stockpile Inventory Data,” hhs.gov.

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This in-depth analysis offers a strategic overview for professionals seeking insights into the clinical, regulatory, and commercial landscapes of AVA, enabling data-driven decisions to navigate biodefense vaccine markets effectively.