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Virus Therapy

Vaxchora Vaccine for Cholera

Phase 2
Recruiting
Led By Nadine Rouphael, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
You are between the ages of 18-49
Be between 18 and 65 years old
Must not have
You are currently taking or have taken Vaxchora Vaccination
You have been diagnosed with Cholera
Timeline
Screening 1 day
Treatment Varies
Follow Up 8 months
Awards & highlights

Study Summary

This trial studies effects of a cholera vaccine in healthy people to see if it produces antibodies & other markers of immune response. It also evaluates safety & side effects.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects from Vaxchora may include typical reactions such as soreness at injection site, mild fever or fatigue. Since it's an oral vaccine for cholera prevention, digestive issues might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 1 day
Treatment ~ Varies
Follow Up ~8 months
This trial's timeline: 1 day for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Positive Responders
Secondary outcome measures
Activated B Cell Levels
Memory B-Cell Levels
Memory T-Cell Levels
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vaxchora VaccinationExperimental Treatment1 Intervention
Healthy subjects will receive a single dose of oral live cholera vaccine.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,187 Total Patients Enrolled
2 Trials studying Vaccine Response
128 Patients Enrolled for Vaccine Response
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,607 Total Patients Enrolled
2 Trials studying Vaccine Response
120 Patients Enrolled for Vaccine Response
Nadine Rouphael, MDPrincipal InvestigatorEmory University
16 Previous Clinical Trials
853 Total Patients Enrolled
2 Trials studying Vaccine Response
120 Patients Enrolled for Vaccine Response

Media Library

Vaxchora (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03251495 — Phase 2
Vaccine Response Research Study Groups: Vaxchora Vaccination
Vaccine Response Clinical Trial 2023: Vaxchora Highlights & Side Effects. Trial Name: NCT03251495 — Phase 2
Vaxchora (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03251495 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Vaxchora Vaccination attained authorization from the FDA?

"There is limited evidence for the efficacy of Vaxchora Vaccination, so it attained a safety score of 2."

Answered by AI

Has Vaxchora Vaccination been tested in other research studies?

"Currently, there are two clinical trials involving Vaxchora Vaccination in operation. Neither of these investigative studies has reached its third phase yet; however, the majority of research is based out of Baltimore and a couple other locations."

Answered by AI

What is the current enrollment capacity for this trial?

"Affirmative, clinicaltrials.gov attests that this research study is in the process of recruiting participants. The initial posting date was August 29th 2017 with the last update taking place on June 1st 2023. Presently, they need 50 patients from at least one medical facility to join the trial."

Answered by AI

Is the age range for participation in this experiment restricted to those over 80?

"As per the prerequisites for enrolment, eligible patients must not exceed 49 years of age and have reached 18."

Answered by AI

Is participation in this experiment an option for me?

"The research team is looking to enroll 50 individuals with cholera who are between 18 and 49 years of age."

Answered by AI

Are participants being accepted for this research study at present?

"Evidence published on clinicaltrials.gov indicates that this research endeavour is presently recruiting participants. It was first posted to the database in August 2017 and has seen updates as recently as June 2021."

Answered by AI

Who else is applying?

What site did they apply to?
The Hope Clinic of Emory University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Immunologic Responses to a Live Attenuated Oral Cholera Vaccine
Nadine Rouphael 2017. "Immunologic Responses to a Live Attenuated Oral Cholera Vaccine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03251495.
~1 spots leftby Jun 2024
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