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

34 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Vaxchora for cholera?

Vaxchora, a single-dose oral vaccine, has shown 90% effectiveness in preventing cholera within 10 days of vaccination in adults traveling to areas where cholera is common. It also produces a strong immune response in children and older adults, making it a reliable option for preventing cholera in various age groups. ^{1 2 3 4 5}

Is the Vaxchora vaccine for cholera safe for humans?

The Vaxchora vaccine, a single-dose oral cholera vaccine, has been shown to be safe in clinical trials, with over 68,000 doses administered in the United States without new safety concerns. It was well tolerated in adults and children, with no significant adverse effects reported. ^{1 2 4 5 6}

How is the Vaxchora vaccine different from other cholera treatments?

Vaxchora is unique because it is the first FDA-approved single-dose, oral vaccine specifically for cholera, offering protection within 10 days, unlike previous non-specific treatments like doxycycline. It is a live attenuated vaccine, meaning it uses a weakened form of the bacteria to stimulate immunity, and is easier to administer compared to multi-dose vaccines. ^{1 2 3 4 5}

Research Team

Nadine Rouphael, MD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vaxchora: A Single-Dose Oral Cholera Vaccine. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Update on CVD 103-HgR single-dose, live oral cholera vaccine. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

An overview of VaxchoraTM, a live attenuated oral cholera vaccine. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Vaxchora: The First FDA-Approved Cholera Vaccination in the United States. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Successful comeback of the single-dose live oral cholera vaccine CVD 103-HgR. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Randomized placebo controlled human volunteer trial of a live oral cholera vaccine VA1.3 for safety and immune response. [2009]