Vaxchora Vaccine for Cholera

Overseen By Nadine Rouphael, MD, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Must not be taking: Corticosteroids, Antibiotics, Blood thinners, others

Disqualifiers: Autoimmune disease, Immunosuppression, Small bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cholera vaccine called Vaxchora to determine its effectiveness in triggering the immune system to combat cholera, a disease that causes severe diarrhea. Researchers aim to understand the body's response by examining different types of immune cells and ensuring the vaccine's safety. The trial seeks healthy participants who have not previously received a cholera vaccine and have not traveled to cholera-prone areas in the past five years. As a Phase 2 trial, this research measures the vaccine's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot participate if you have used corticosteroids in the last 30 days, antibiotics in the past 14 days, or blood thinners like aspirin or NSAIDs in the past week if undergoing intestinal biopsies. If you are taking medications for GERD or dyspepsia, you may also be excluded.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the Vaxchora vaccine prevents cholera in adults. As an oral vaccine, it is taken by mouth. Most people tolerate the vaccine well, experiencing no serious side effects.

Studies have found that some side effects can occur, including mild symptoms like fatigue, headache, or upset stomach. Severe allergic reactions are rare but possible, especially in those allergic to the vaccine's ingredients. It is important to inform a doctor about any allergies before considering the vaccine.

Vaxchora is approved for use against certain types of cholera, indicating a safety record for those cases. However, it does not protect against all forms of cholera. For the specific type it targets, the vaccine has been shown to be safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Vaxchora is unique because it is an oral live vaccine designed specifically for cholera, offering a different approach compared to traditional inactivated vaccines. Most current cholera vaccines require multiple doses over time, but Vaxchora stands out by needing just a single dose, which simplifies the vaccination process and can enhance compliance. This single-dose convenience, combined with its oral delivery method, makes Vaxchora particularly appealing for rapid deployment in outbreak situations, where quick protection is crucial. Researchers are excited about its potential to provide effective and immediate protection against cholera with a streamlined administration process.

What evidence suggests that Vaxchora might be an effective treatment for cholera?

Studies have shown that Vaxchora, an oral vaccine, effectively prevents cholera caused by the V. cholerae O1 strain. One study found it to be 90.3% effective 10 days after vaccination and 79.5% effective after 90 days. Another study reported 93% effectiveness for individuals exposed to the bacteria 10 days post-vaccination and 86% effectiveness after three months. These results suggest that Vaxchora is a strong option for cholera protection, especially shortly after vaccination. ^{1 2 6 7 8}

Who Is on the Research Team?

Nadine Rouphael, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

Healthy individuals who can consent, attend all visits, and are not pregnant can join this cholera vaccine trial. They must be in good health without a suppressed immune system or abnormal stool patterns. Exclusions include recent illness, living with young children or immunocompromised people, planned vaccinations, allergies to the vaccine components, pregnancy within one month of vaccination, food industry workers, healthcare workers with patient contact.

Inclusion Criteria

Are in good health, as determined by medical history and targeted physical exam related to this history

I am a woman who can have children, tested negative for pregnancy, and will use two birth control methods after getting the Vaxchora vaccine.

You are between the ages of 18-49

Exclusion Criteria

You are currently taking or have taken Vaxchora Vaccination

You have been diagnosed with Cholera

You have a BMI > 35

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Vaccination

Participants receive a single dose of oral live cholera vaccine

1 day

1 visit (in-person)

Post-vaccination Monitoring

Participants are monitored for immune response and adverse events

4 weeks

Multiple visits for blood draws and assessments on Days 1, 8, 11, 15, and 29

Follow-up

Participants are monitored for long-term safety and immune response

Up to 12 months

1 visit (in-person) at Day 365

What Are the Treatments Tested in This Trial?

Interventions

• Vaxchora

Trial Overview The study tests how healthy adults' immune systems respond to the oral cholera vaccine Vaxchora®. It looks at antibody levels and other immune markers like plasmablasts and T cells after vaccination. The safety of the vaccine is also being evaluated.

How Is the Trial Designed?

Group I: Vaxchora Vaccination Experimental Treatment 1 Intervention

Healthy participants will receive a single dose of oral live cholera vaccine.

Vaxchora is already approved in United States for the following indications:

Approved in United States as Vaxchora for:

• Prevention of cholera

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

Vaxchora is the first FDA-approved vaccine specifically designed to prevent cholera infection, which is particularly important for travelers visiting high-risk areas in Africa and Southeast Asia.

As a live attenuated, single-dose oral vaccine, Vaxchora offers a targeted prophylactic option against cholera, reducing the risk of severe diarrhea and dehydration caused by the bacterium Vibrio cholerae.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaxchora: The First FDA-Approved Cholera Vaccination in the United States. Mosley, JF., Smith, LL., Brantley, P., et al.[2020]

The oral cholera vaccine Vaxchora™ was licensed by the US FDA in 2016 and has been shown to effectively protect against cholera for at least 3 months after a single dose in US volunteers.

Despite its effectiveness, Vaxchora™ presents challenges for use in resource-poor settings due to requirements for reconstitution, age restrictions (18 to 64 years), lack of data in endemic populations, and issues with cold chain storage and cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of VaxchoraTM, a live attenuated oral cholera vaccine. Saluja, T., Mogasale, VV., Excler, JL., et al.[2023]

Vaxchora is a single-dose oral vaccine that provides 90.3% protection against cholera caused by V cholerae serogroup O1, based on human trials conducted before its FDA approval.

The vaccine is generally well-tolerated, with common side effects including fatigue, headache, and abdominal pain, but its safety and efficacy have not been established for children, immunocompromised individuals, or pregnant and breastfeeding women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaxchora: A Single-Dose Oral Cholera Vaccine. Cabrera, A., Lepage, JE., Sullivan, KM., et al.[2018]

Citations

1. vaxchora.com vaxchora.com/

Vaxchora® Oral Cholera Vaccine (Live) The effectiveness of VAXCHORA has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8708586/

Oral Cholera Vaccine Efficacy and Effectiveness - PMC The vaccine efficacy of WC was found to be 56%, and for WC-BS, 64% (Table 2). Among vaccinated participants in both groups that developed ...

3. fda.gov fda.gov/media/128415/download

Package Insert - VAXCHORA The effectiveness of VAXCHORA has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5614415/

Vaxchora: The First FDA-Approved Cholera Vaccination in ... CLINICAL TRIALS​​ Vaxchora was shown to be 90.3% effective against V. cholerae O1 10 days after vaccination and 79.5% effective 90 days after vaccination. ...

5. cdc.gov cdc.gov/acip/grade/cholera-cvd-103-hgr.html

Grading of Recommendations, Assessment, Development ... The vaccine efficacy (VE) was 93% for those challenged 10 days post-vaccination and 86% for those challenged 3 months post-vaccination.

6. ec.europa.eu ec.europa.eu/health/documents/community-register/2023/20230922160546/anx_160546_en.pdf

Vaxchora, Cholera Vaccine (recombinant, live, oral) Not applicable. 5.3 Preclinical safety data. No preclinical safety data are available for Vaxchora. 6. PHARMACEUTICAL PARTICULARS. 6.1 List of excipients.

7. vaxchora.com vaxchora.com/consumer/

Consumer & Patient Information | Vaxchora® Oral Cholera ... VAXCHORA has not been shown to protect against cholera caused by bacteria not covered by the vaccine.2 See “Important Safety Information for VAXCHORA” below for ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/cholera-vaccine-oral-route/description/drg-20062780

Cholera vaccine (oral route) - Side effects & uses Cholera vaccine is used in adults to help prevent cholera. Cholera is a serious disease that can cause death. It is caused by a germ called Vibrio cholerae.