Immunologic Responses to a Live Attenuated Oral Cholera Vaccine

February 11, 2026 updated by: Nadine Rouphael, Emory University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Vibrio cholerae causes an acute diarrheal disease responsible for more than 100,000 deaths and affects an estimated 3 to 5 million people annually. Recent epidemics in Haiti and Africa illustrate the continued reach of this pathogen. Across the globe, one billion people lack access to safe drinking water and are vulnerable to cholera. The increasing disease burden, and emergence of more virulent strains, suggest that more aggressive approaches to preventing cholera are needed. This includes renewed efforts to understand the mechanism of protective immunity against cholera and to improve the protective efficacy of current cholera vaccines.

Vaxchora is a live attenuated cholera vaccine that protects against some cholera strains. It has been approved by the FDA since June 2016. Since October, 2016, this vaccine has been recommended for certain travelers 18 through 64 years of age going to cholera-affected areas. The purpose of this study is to look at the immune responses to the FDA approved cholera vaccine (Vaxchora®).

This study aims to enroll 50 participants who will receive the Vaxchora live cholera vaccine, of whom 30 will undergo two procedures for small intestinal biopsies: one at screening and the other post vaccination (25 participants at Day 29 and 5 participants at day 90) by an upper endoscopy biopsy (EGD).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30030
        • The Hope Clinic of Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Capable of informed consent and provision of written informed consent before any study procedures
  • Capable of attending all study visits according to the study schedule
  • Are in good health, as determined by medical history and targeted physical exam related to this history
  • Female subjects of childbearing age must have a negative urine pregnancy test before study vaccination, and must use two forms of contraception to avoid pregnancy within one month of Vaxchora administration

Exclusion Criteria:

  • Have an acute illness within 72 hours before vaccination
  • Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination
  • Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination
  • Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination
  • Reside with individuals under the age of 2 or with an immunocompromised individuals
  • Have a known history of autoimmune disease
  • Have a history of Guillain-Barre Syndrome
  • Have plans to receive any vaccine from 28 days prior to study vaccination until Day 29
  • Has previously received a cholera vaccine or have a known history of V. Cholerae.
  • Have donated blood or blood products within 56 days before study vaccination, plan to donate blood at any time during the 56-day duration of subject study participation, or plan to donate blood within 56 days after the last blood draw
  • Have known hypersensitivity or allergy to any component of the vaccine or history of anaphylaxis with a vaccine or vaccine component
  • Have allergy to tetracycline and/or ciprofloxacin
  • Are pregnant or breastfeeding or plan to within one month of vaccination
  • Traveled to a cholera endemic area and had traveler's diarrhea in the previous 5 years
  • Have abnormal stool pattern (fewer than 3 stools/ week or greater than 2 stools/ day) or regular use of laxatives in the last 6 months
  • Have current or recent antibiotic use in the past 14 days
  • Are healthcare workers who have direct contact with patients who are immunocompromised, have unstable medical conditions, or are under the age of 2
  • Are childcare caregivers who have direct contact with children who are 2 years or younger
  • Are employed in the food industry
  • Have received any vaccine within the previous 21 days
  • History of bleeding disorders or current use of warfarin, aspirin, heparin, nonsteroidal anti-inflammatory drugs (NSAIDs) or other blood thinner/ anticoagulant medications in the past week for subjects undergoing intestinal biopsies.
  • Use of benzodiazepines or narcotics for subjects undergoing intestinal biopsies 4 weeks prior to the procedure
  • Any contraindications to endoscopy/concerns of the anesthesiologist for subjects who agree for esophagogastroduodenoscopy (EGD)/biopsies
  • Body mass index (BMI) > 35 kg/m^2
  • Have a diagnosis of any small bowel disease. This includes but is not limited to inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, indeterminate colitis, or microscopic colitis), small bowel obstruction, celiac disease, h/o small bowel resection, small bowel lymphoma, Whipple's disease, primary intestinal lymphangiectasis, abdominal radiation.
  • Current medications for the treatment of gastroesophageal reflux disease (GERD) or dyspepsia
  • History of Helicobacter pylori (H. pylori) infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vaxchora Vaccination
Healthy participants will receive a single dose of oral live cholera vaccine.
Drug: Vaxchora
Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants will receive one single oral dose of 100 mL.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Level of Antibody Titers in Serum
Time Frame: Day 1 (pre-vaccination), Day 29
Antibody response is evaluated as the level of antibody titers in serum. Higher vibriocidal antibody titers indicate greater protection against cholera.
Day 1 (pre-vaccination), Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasmablast Levels
Time Frame: Day 1 (pre-vaccination), Day 8, Day 29
Plasmablasts are collected via blood draw and isolated and assessed for counts by the study team.
Day 1 (pre-vaccination), Day 8, Day 29
Activated B Cell Levels
Time Frame: Day 1 (pre-vaccination), Day 8, Day 29
Activated B cells are collected via blood draw and isolated and assessed for counts by the study team.
Day 1 (pre-vaccination), Day 8, Day 29
Memory B Cell Levels
Time Frame: Day 1 (pre-vaccination), Day 29
Memory B cells are collected via blood draw and isolated and assessed for counts by the study team. The level of memory B cells is evaluated as the percentage of antigen specific immunoglobulin (Ig) secreting cells divided by the total Ig secreting cells.
Day 1 (pre-vaccination), Day 29
Number of Monoclonal Antibodies Produced Per Participant
Time Frame: Day 8
The number of antigen-specific monoclonal antibodies (mAbs) was assessed in a subset of participants on Day 8 post-vaccination. Peripheral blood mononuclear cells (PBMCs) were isolated, and antigen-specific plasmablasts were single-cell sorted using fluorescently labeled V. cholerae antigens (e.g., CTB and LPS). Paired immunoglobulin heavy and light chain variable regions were amplified by RT-PCR, cloned into expression vectors, and expressed in mammalian cells. The number of unique antigen-specific monoclonal antibodies was determined by binding assays (e.g., ELISA).
Day 8
Number of Cholera Toxin B (CTB) Specific Monoclonals and Lipopolysaccharide (LPS) Specific Monoclonal Antibodies Per Participant
Time Frame: Day 8
The monoclonal antibodies obtained were characterized as cholera toxin B (CTB) specific monoclonals and lipopolysaccharide (LPS) specific monoclonals. The characterization of monoclonal antibodies against V. cholerae is assessed in a subset of participants.
Day 8
Number of Adverse Events
Time Frame: Up to Day 8, Up to Day 29
The number of solicited and unsolicited adverse events were collected.
Up to Day 8, Up to Day 29
Number of Serious Adverse Events
Time Frame: Up to Day 365
The number of serious adverse events were collected during the duration of the study.
Up to Day 365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nadine Rouphael, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 6, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00097012
  • R01AI137127 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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