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

VAXCHORA Market Analysis and Financial Projection

VAXCHORA: Clinical Trials, Market Analysis, and Projections

Introduction to VAXCHORA

VAXCHORA is the first and only FDA-approved single-dose oral cholera vaccine, developed by PaxVax. It is designed to protect against cholera, a severe diarrheal disease caused by the bacterium Vibrio cholerae. Here, we will delve into the clinical trials, market analysis, and projections for VAXCHORA.

Clinical Trials and Efficacy

Challenge Study in Adults

VAXCHORA was evaluated in a randomized, double-blind, saline placebo-controlled V. cholerae challenge study involving adults aged 18-45 years. The study demonstrated significant efficacy in preventing moderate to severe diarrhea following challenge with V. cholerae O1 El Tor Inaba at both 10 days and 3 months post-vaccination. In the 10-day challenge group, only 5.7% of VAXCHORA recipients developed moderate to severe diarrhea, compared to a much higher rate in the placebo group. At 3 months, 12.1% of VAXCHORA recipients developed moderate to severe diarrhea, still significantly lower than the placebo group[1].

Immunogenicity Trials

Immunogenicity trials, including Studies 1, 4, and 5, showed high seroconversion rates. Seroconversion, defined as a ≥4-fold rise in serum vibriocidal antibody, occurred in 93.5% of vaccine recipients at 10 days post-vaccination in Study 1. Similar high seroconversion rates were observed in other age groups, including children and adolescents, indicating strong immune response across various demographics[1].

Safety in Children

The safety of VAXCHORA in children was evaluated in a randomized, placebo-controlled, multicenter clinical trial involving 543 children aged 2-17 years. The trial found that serious adverse events were rare, with only 0.2% of VAXCHORA recipients reporting such events, and none were related to the vaccination[1].

Market Analysis

Global Market Size and Growth

The global cholera vaccine market, which includes VAXCHORA, has been growing steadily. In 2017, the market was valued at $65 million and is projected to reach $207 million by 2025, with a Compound Annual Growth Rate (CAGR) of 15.6% from 2018 to 2025[2].

Regional Market Trends

Asia-Pacific dominated the market in 2017 and is expected to maintain this trend due to the high prevalence of cholera and increasing importance of immunization. However, North America is anticipated to grow at the highest CAGR during the forecast period, largely due to the launch of VAXCHORA in the U.S. and the increasing number of travelers to cholera-affected countries[2].

Competitive Landscape

VAXCHORA is part of a competitive market that includes other vaccines like Dukoral, Shanchol, Euvichol, and Euvichol-Plus. However, VAXCHORA is projected to exhibit the fastest market growth due to its advantages, such as single-dose immunization and reduced adverse effects[2][5].

Market Projections

Future Growth

The global cholera vaccine market is expected to continue growing, driven by factors such as increased awareness of cholera outbreaks, lack of proper sanitation, and the rise in international travel. VAXCHORA, in particular, is expected to grow at a CAGR of 14.1% over the forecast period due to its effectiveness and ease of administration[5].

Market Size Forecast

By 2026, the cholera vaccine market is forecast to reach $239.6 million, growing at a CAGR of 7.9% from 2021 to 2026. By 2030, the market is anticipated to grow further, driven by persistent research, technological advancements, and strengthened vaccination campaigns by international health organizations and government initiatives[3][5].

Key Factors Driving Market Growth

Increasing Awareness and Travel

The growing awareness of cholera risk and the increasing number of travelers to endemic regions are significant drivers of the market. VAXCHORA's single-dose regimen and oral administration make it particularly appealing for travelers and vulnerable populations[2][5].

Technological Advancements

Continuous research and technological advancements are expected to enhance the efficacy and accessibility of cholera vaccines. Novel approaches and improved formulations are likely to further drive market growth[5].

Public Health Initiatives

Efforts by international health organizations and government initiatives to strengthen vaccination campaigns are crucial in reducing cholera outbreaks. These initiatives are expected to boost the demand for effective vaccines like VAXCHORA[5].

Challenges and Opportunities

Adverse Effects and Regulatory Approval

While VAXCHORA has shown a favorable safety profile, the risk of adverse effects and the time taken for regulatory approval can impede market growth. However, high growth opportunities in untapped markets offer significant profitable opportunities for market players[2].

Untapped Markets

The Asia-Pacific region, particularly countries with high cholera prevalence, presents substantial opportunities for market growth. Expanding vaccination programs in these regions can significantly contribute to the overall market size[2][5].

Conclusion

VAXCHORA has demonstrated strong efficacy and safety in clinical trials, making it a valuable tool in the prevention of cholera. The global cholera vaccine market is poised for significant growth, driven by increasing awareness, technological advancements, and public health initiatives. As the first and only FDA-approved single-dose oral cholera vaccine, VAXCHORA is well-positioned to capture a substantial share of this growing market.

Key Takeaways

• Efficacy: VAXCHORA has shown high efficacy in preventing moderate to severe diarrhea caused by V. cholerae in clinical trials.
• Immunogenicity: High seroconversion rates indicate a strong immune response across various age groups.
• Safety: The vaccine has a favorable safety profile, especially in children.
• Market Growth: The global cholera vaccine market is expected to grow significantly, with VAXCHORA projected to exhibit the fastest growth.
• Regional Trends: Asia-Pacific and North America are key regions driving market growth.
• Drivers: Increasing awareness, technological advancements, and public health initiatives are driving market growth.

FAQs

What is VAXCHORA?

VAXCHORA is the first and only FDA-approved single-dose oral cholera vaccine, designed to protect against cholera caused by Vibrio cholerae.

How effective is VAXCHORA in clinical trials?

VAXCHORA demonstrated significant efficacy in preventing moderate to severe diarrhea following challenge with V. cholerae O1 El Tor Inaba at both 10 days and 3 months post-vaccination[1].

What are the common adverse reactions to VAXCHORA?

Common adverse reactions include tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, and diarrhea[4].

Which regions are driving the growth of the cholera vaccine market?

Asia-Pacific and North America are the key regions driving the growth of the cholera vaccine market, with Asia-Pacific dominating the market and North America expected to grow at the highest CAGR[2].

What are the key factors driving the market growth for VAXCHORA?

Increasing awareness of cholera risk, lack of proper sanitation, rise in international travel, technological advancements, and public health initiatives are key factors driving market growth[2][5].

Cited Sources

1. Vaxchora.com: Vaxchora® Oral Cholera Vaccine (Live) - Study 2 — Challenge Study in Adults Aged 18-45.
2. Allied Market Research: Cholera Vaccine Market Size, Share & Growth Report, 2025.
3. IndustryARC: Cholera Vaccine Market Size Report, 2021-2026.
4. NITA Resource: CDC Advisory Committee On Immunization Practices Votes To Recommend Vaxchora.
5. Grand View Research: Cholera Vaccines Market Size, Share | Industry Report, 2030.