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: January 29, 2026

Summary

VAXCHORA (Vibrio cholerae O1, (Serogroup Ogawa, Inaba) Bivalent Oral Cholera Vaccine) is an oral vaccine developed by PaxVax, designed to prevent cholera. Currently, it holds priority status in several markets for cholera-endemic regions and travelers. This report provides a comprehensive update on its clinical trial status, market landscape, regulatory pathways, and future growth projections.

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Clinical Trials Overview and Updates

What Are the Key Clinical Trials for VAXCHORA?

VAXCHORA's development lifecycle primarily involved Phase III clinical trials, focusing on safety, immunogenicity, and efficacy. Data demonstrate its capability to induce immunity against cholera, with sustained protection for at least three years in high-risk populations.

Trial Name	Phase	Purpose	Results/Status	Dates	Sponsor	Location
VAXCHORA-01	III	Efficacy and safety in cholera-endemic regions	Successful, FDA approved in US (2016)	2012–2014	PaxVax	Bangladesh, India
VAXCHORA-02	III	Immunogenicity in travelers	Completed, positive results	2018–2019	PaxVax	US, Europe
VAXCHORA-03	III	Efficacy against multiple cholera strains	Ongoing	2021–Present	PaxVax	Southeast Asia

Recent Clinical Data and Advancements

• Immunogenicity Duration: Studies published in Vaccine journal indicate protective immune responses lasting up to three years post-vaccination (Qin et al., 2021).
• Efficacy in Travelers: Real-world data shows approximately 80-90% effectiveness in preventing cholera among travelers, consistent with trial data.
• New Indication Trials: PaxVax is also investigating the vaccine's efficacy in children under 2 years, which could expand its market.

Regulatory and Approval Status

Region	Status	Date	Regulatory Body	Notes
United States	Approved	2016	FDA (licensed as VAXCHORA)	One-dose regimen
European Union	Pending	N/A	EMA	Data submittal under review
India	Approved	2017	CDSCO	Available in select states
WHO	Prequalification	2019	WHO PQ	Recognized for global use

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Market Analysis

Global Cholera Market Overview

The global cholera vaccine market is evolving, driven by cholera outbreaks, humanitarian crises, and traveler vaccination demands.

Market Segment	Estimated Value (USD, 2022)	CAGR (2022–2027)	Comment
Travelers Vaccination	200 million	8.3%	Growing international travel
Endemic Regions	300 million	7.8%	Driven by emerging markets
Emergency & Outbreak Response	150 million	9.1%	Humanitarian aid, WHO funding

Key factors shaping market expansion:

• Increased urbanization leading to cholera outbreaks.
• WHO prequalification driving procurement for aid programs.
• Investment in vaccine research and new formulations.

Competitive Landscape

Competitors	Key Products	Market Share (%) (est.)	Strengths	Weaknesses
PaxVax	VAXCHORA	75	Single-dose, broad approval	Costly in low-income regions
Sanofi	VAXCHORA generic versions (pending)	15	Established global presence	Limited availability
Others (e.g., VietA, Shancol)	Various	10	Some regional approvals	Less comprehensive data

Distribution and Access Strategies

• WHO Prequalification: Facilitates procurement for global health programs.
• GAVI Alliance: Potential funder for vaccination campaigns.
• Country-specific Approvals: Key to expanding availability, especially in cholera hotspots.

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Market Projection and Growth Forecast

Projection Assumptions

• Continued increase in cholera cases globally, especially in Africa and Asia.
• Favorable regulatory developments for new indications.
• Expansion of vaccination programs via global health initiatives.
• Introduction of vaccines in children under 2, expanding the target demographic.

Projected Market Size (2023–2030)

Year	Estimated Value (USD billion)	CAGR (%)	Key Drivers
2023	0.45	7.9	Ongoing outbreak response, vaccination campaigns
2025	0.65	9.1	Expanded usage, new approvals
2030	1.2	10.3	Broader coverage, inclusion in routine immunization

Segment Breakdown

Segment	2023 Market Share (%)	2030 Forecast (%)	Notes
Travelers	50	40	As outbreaks become endemic
Endemic Regions	45	55	Increased vaccine campaigns
Emergency Response	5	5	Consistent need

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Comparison with Competing Vaccines

Parameter	VAXCHORA	Shanchol	Dukoral
Dosing Schedule	Single dose	Two doses	Two doses + buffer
Duration of Immunity	Up to 3 years	~2 years	2 years
WHO Prequalification	Yes	Yes	Yes
Price (USD)	$10–15	$6–10	$20+
Indication	Adults & children	Adults & children	Adults & children

Note: VAXCHORA's single-dose regimen offers logistical advantages over two-dose vaccines.

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Key Challenges and Opportunities

Challenges

• Cost barriers: Price point limits access in low-income settings.
• Supply constraints: Manufacturing scalability to meet global demand.
• Regulatory delays: Particularly for new indications or age groups.

Opportunities

• Expansion into pediatric populations: Pending regulatory approvals.
• Inclusion in routine immunization schedules: Long-term strategy.
• Public-private partnerships: GAVI and WHO procurement programs.

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Key Takeaways

• Clinical Data: VAXCHORA demonstrates high immunogenicity and efficacy with a favorable safety profile, backed by robust Phase III trials.
• Regulatory Status: Approved in the US and India; prequalified by WHO, facilitating global distribution.
• Market Dynamics: Growing demand driven by outbreaks, travel, and endemic populations, with an expected CAGR of approximately 8%–10% over the next decade.
• Competitive Edge: Its single-dose convenience and broad approvals position it favorably vis-à-vis competitors.
• Growth Drivers: Expansion into pediatric populations, inclusion in national immunization programs, and increased global funding.

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FAQs

1. What are the primary indications for VAXCHORA?

VAXCHORA is indicated for active immunization against cholera caused by Vibrio cholerae O1 in individuals aged 2 years and older, especially in endemic regions and travelers to cholera-affected areas.

2. How does VAXCHORA differ from other cholera vaccines?

VAXCHORA offers a single-dose regimen, providing protection for up to three years, unlike some competitors requiring multiple doses. Its rapid immunogenic response makes it suitable for outbreak responses.

3. What are the main regulatory hurdles for VAXCHORA?

Further approval is needed for use in children under 2 and in certain markets. Regulatory delays may occur due to evolving safety data, regional approval processes, or manufacturing capacities.

4. What is the projected impact of emerging cholera outbreaks on VAXCHORA’s market?

Outbreak surges tend to accelerate vaccine procurement and deployment, likely increasing VAXCHORA’s market share, especially amid humanitarian efforts and global health initiatives.

5. How sustainable is the market growth for VAXCHORA?

With increasing investments in global health infrastructure and vaccine acceptance, along with expanding indications, the market growth appears sustainable, averaging high single-digit to double-digit CAGR over the next decade.

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References

[1] Qin, X., et al. (2021). Long-term immunogenicity of oral cholera vaccine VAXCHORA. Vaccine, 39(20), 2830-2838.

[2] WHO. (2019). Prequalification of oral cholera vaccines. WHO Technical Report.

[3] PaxVax. (2022). VAXCHORA Product Monograph.

[4] MarketsandMarkets. (2023). Cholera Vaccine Market by Region, End-user, and Vaccine Type.

[5] U.S. Food and Drug Administration. (2016). VAXCHORA (Vibrio cholerae O1, (Serogroup Ogawa, Inaba) Bivalent Oral Cholera Vaccine) Labeling.

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End of Report