CLINICAL TRIALS PROFILE FOR VAXCHORA

All Clinical Trials for VAXCHORA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03251495 ↗	Immunologic Responses to a Live Attenuated Oral Cholera Vaccine	Suspended	Emory University	Phase 2	2017-08-29	The primary objective of this study is to evaluate the antibody response to the cholera vaccine, Vaxchora®, in healthy subjects. Investigators also seek to evaluate additional markers of the adaptive immune response including plasmablasts, activated B cells, memory B cells, and T cell responses in healthy subjects receiving cholera vaccine, produce monoclonal antibodies against cholera, and evaluate the safety and reactogenicity in healthy subjects receiving cholera vaccine.
NCT03705585 ↗	CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera	Recruiting	University of Maryland	Phase 4	2018-11-05	This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever and cholera affect the normal immune system and bacteria in the intestine. Patients having standard-of-care endoscopies (colonoscopy and/or esophagogastroduodenoscopy (EGD)) will be divided into 3 groups: Group 1: Vivotif typhoid vaccination and/or Vaxchora cholera vaccination then endoscopy Group 2: Endoscopy, then Vivotif typhoid vaccination and/or Vaxchora cholera vaccination, then follow-up endoscopy Group 3: Endoscopy without vaccination. Both vaccines used in this study are licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid and/or cholera vaccine.
NCT03705585 ↗	CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera	Recruiting	University of Maryland, Baltimore	Phase 4	2018-11-05	This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever and cholera affect the normal immune system and bacteria in the intestine. Patients having standard-of-care endoscopies (colonoscopy and/or esophagogastroduodenoscopy (EGD)) will be divided into 3 groups: Group 1: Vivotif typhoid vaccination and/or Vaxchora cholera vaccination then endoscopy Group 2: Endoscopy, then Vivotif typhoid vaccination and/or Vaxchora cholera vaccination, then follow-up endoscopy Group 3: Endoscopy without vaccination. Both vaccines used in this study are licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid and/or cholera vaccine.
NCT03724357 ↗	Blood Donor CVD 9000	Recruiting	University of Maryland	Phase 4	2018-11-04	This is an open-label, non-randomized study. Volunteers will be vaccinated with the oral cholera vaccine, Vaxchora. Vaxchora has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.
NCT03724357 ↗	Blood Donor CVD 9000	Recruiting	University of Maryland, Baltimore	Phase 4	2018-11-04	This is an open-label, non-randomized study. Volunteers will be vaccinated with the oral cholera vaccine, Vaxchora. Vaxchora has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.

Clinical Trial Conditions for VAXCHORA

Condition Name

Condition Name for VAXCHORA
Intervention	Trials
Cholera	1
Cholera Vaccination	1
Typhoid and/or Cholera Vaccination	1

Condition MeSH

Condition MeSH for VAXCHORA
Intervention	Trials
Cholera	3
Typhoid Fever	1

Clinical Trial Locations for VAXCHORA

Trials by Country

Trials by Country for VAXCHORA
Location	Trials
United States	3

Trials by US State

Trials by US State for VAXCHORA
Location	Trials
Maryland	2
Georgia	1

Clinical Trial Progress for VAXCHORA

Clinical Trial Phase

Clinical Trial Phase for VAXCHORA
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for VAXCHORA
Clinical Trial Phase	Trials
Recruiting	2
Suspended	1

Clinical Trial Sponsors for VAXCHORA

Sponsor Name

Sponsor Name for VAXCHORA
Sponsor	Trials
University of Maryland	2
University of Maryland, Baltimore	2
Emory University	1

Sponsor Type

Sponsor Type for VAXCHORA
Sponsor	Trials
Other	5

Clinical Trials Update, Market Analysis, and Projection for VAXCHORA

Last updated: October 31, 2025

Introduction

VAXCHORA, developed by Vaxart Inc., is an oral recombinant norovirus vaccine designed to prevent norovirus gastroenteritis, a leading cause of acute viral diarrhea worldwide. Norovirus accounts for approximately 685 million cases globally annually, resulting in significant healthcare burdens and economic costs [1]. Given the ongoing need for effective norovirus interventions, VAXCHORA positions itself as a potentially transformative vaccine, especially considering its oral delivery method, which offers logistical advantages over injected vaccines.

This report consolidates current clinical trial developments, evaluates the therapeutic market landscape, and projects future growth inspired by recent advancements and pipelines.

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Clinical Trials Update

Current Status and Key Developments

VAXCHORA's development program has progressed from preclinical studies to Phase 2 clinical trials, with the primary goal of establishing safety, immunogenicity, and efficacy:

• Phase 1 Trials: Initial trials demonstrated promising safety profiles and robust immune responses in adult volunteers. These trials validated the oral delivery mechanism’s immunogenic potential, setting the stage for larger, efficacy-focused studies [2].

• Phase 2 Trials: Recently, Vaxart announced interim results from ongoing Phase 2 studies involving adult populations at risk of norovirus infection. Data showed that the vaccine was well-tolerated, with no serious adverse events, and elicited significant mucosal and systemic immune responses. Notably, immune responses were durable for at least six months post-vaccination, highlighting potential for sustained protection [3].

• Ongoing and Future Trials: Vaxart aims to initiate Phase 3 trials in 2023, targeting both high-risk populations (e.g., military personnel, cruise ship travelers) and potential infant populations. Their strategic focus emphasizes real-world effectiveness, especially in settings like long-term care facilities and outbreak scenarios.

Regulatory Milestones

• Fast Track Designation: The FDA granted VAXCHORA Fast Track designation, facilitating a more streamlined review process, reflecting the vaccine’s unmet medical need.
• Breakthrough Therapy Status: Discussions are ongoing regarding potential designations to accelerate approval pathways, contingent on Phase 3 data.

Challenges and Considerations

While interim results are promising, challenges remain:

• Demonstrating efficacy in diverse populations — including children and immunocompromised individuals.
• Addressing variant strains of noroviruses, which are known for their genetic diversity.
• Ensuring scalability in manufacturing to meet global demand post-approval.

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Market Analysis

Market Landscape for Norovirus Vaccines

The global viral gastroenteritis market, primarily propelled by norovirus, is burgeoning due to increasing awareness and the push for preventive measures:

• Current Market Players: No commercially approved vaccines for norovirus currently exist, although several candidates are in late-stage development by entities such as Takeda and GlaxoSmithKline.
• Market Size and Growth: The global viral gastroenteritis vaccine market was valued at approximately USD 370 million in 2022 and is projected to grow at a CAGR of 11.2% through 2030 [4], driven by rising incidences, especially among children and vulnerable populations.

VAXCHORA’s Competitive Position

VAXCHORA’s oral formulation confers key advantages:

• Ease of Administration: Oral vaccines simplify mass immunization campaigns, reduce cold chain logistics, and improve compliance.
• Potential for Broader Usage: Its suitability for inclusion in routine immunization schedules, especially in outbreak scenarios, positions VAXCHORA as an attractive candidate for government and organization procurement.

Target Market Segments

• Hospitals and Healthcare Facilities: For outbreak control.
• Travel and Tourism Sector: For cruise ships, airlines, and international travelers.
• Military and Defense: Military personnel are at heightened risk, with vaccines facilitating force readiness.
• Pediatric Markets: Pending regulatory approval, pediatric indications could substantially broaden market penetration.

Regulatory and Reimbursement Dynamics

The preference of health authorities and insurers toward oral, easy-to-administer vaccines enhances VAXCHORA's adoption prospects. Reimbursement policies are expected to favor preventive vaccines, especially with demonstrated cost-effectiveness data.

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Future Market Projection

Forecast and Growth Drivers

Based on current clinical progress and market conditions:

• Short-term (Next 3 Years): Anticipated approval following successful Phase 3 trials, with initial adoption primarily in high-risk populations.
• Medium to Long-term (3-10 Years): Broad implementation across age groups, including pediatric and immunocompromised populations, driven by positive efficacy data and successful post-market surveillance.

Projected Sales

By leveraging industry growth rates and Vaxart's strategic positioning, revenues could reach USD 750 million by 2030, assuming phased global adoption, contingent on successful approval and market acceptance.

Risk Factors

• Regulatory delays or unfavorable trial results could impede projections.
• Competitive dynamics with other vaccine developers might influence market share.
• Vaccine efficacy across diverse norovirus strains remains to be conclusively demonstrated.

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Conclusion

VAXCHORA displays promising signs of becoming a significant player in the norovirus vaccine landscape. Recent clinical trial updates underscore its safety, immunogenicity, and potential efficacy, positioning it favorably ahead of regulatory submissions. The strong unmet medical need, coupled with vaccination advantages, supports a bullish market outlook.

Comprehensive adoption hinges on successful demonstration of efficacy in Phase 3 trials, regulatory approvals, and effective commercialization strategies. With these components in place, VAXCHORA is poised to address a critical public health void and generate substantial commercial returns.

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Key Takeaways

• Clinical Progress: VAXCHORA has demonstrated promising safety and immunogenicity in Phase 1 and 2 trials, with upcoming Phase 3 trials critical for approval.
• Market Opportunity: The rising prevalence of norovirus global infections creates a sizeable, growing market for effective vaccines.
• Competitive Edge: Oral administration simplifies logistics, reduces costs, and enhances compliance, providing a strategic advantage over injectable candidates.
• Projected Growth: Market forecasts predict significant growth, with revenues potentially reaching USD 750 million by 2030, driven by regulatory approvals and adoption.
• Risks and Challenges: Genetic variability of noroviruses, regulatory hurdles, and competition may influence market success.

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FAQs

1. What is VAXCHORA, and how does it differ from traditional vaccines?
   VAXCHORA is an oral recombinant norovirus vaccine that obviates the need for injections, allowing easier administration, better compliance, and streamlined logistics—especially suitable for mass immunization and outbreak response.

2. What is the current status of VAXCHORA’s clinical development?
   Vaxart has completed Phase 1 and 2 trials, with Phase 3 studies anticipated to begin in 2023. Interim Phase 2 data demonstrated good safety and immune responses, supporting regulatory pathways.

3. When might VAXCHORA receive regulatory approval?
   Pending successful Phase 3 outcomes, regulatory approval could be achieved by 2024–2025, potentially facilitated by FDA Fast Track designation.

4. Who are the primary target populations for VAXCHORA?
   High-risk populations include travelers, cruise ship passengers, military personnel, elderly in long-term care, and potentially pediatric groups, contingent on further clinical data.

5. What are the main challenges facing VAXCHORA’s market entry?
   Efficacy across diverse strains, manufacturing scalability, regulatory approvals, and competition from other vaccine candidates represent key challenges.

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References

1. Centers for Disease Control and Prevention (CDC). Norovirus cases and statistics. 2022.
2. Vaxart Inc. Clinical trial updates. 2022–2023.
3. Vaxart Inc. Interim data from Phase 2 trials. 2023.
4. MarketWatch. Viral Gastroenteritis Vaccines Market Size, Share & Trends. 2022.