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CompletedNCT03251495Updated Feb 13, 2026Results posted

Immunologic Responses to a Live Attenuated Oral Cholera Vaccine

A Phase 2 interventional study of Vaxchora in Cholera, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by Emory University · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years to 49 Years
Sex
All
01

Study summary

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.

Read the 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).

02

Conditions studied

  • Cholera

Keywords

  • Vaccination
  • Contagious Diseases
  • Tropical Medicine
  • Infectious Diseases
03

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Vaxchora Vaccination

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

    Drug: Vaxchora

Interventions

  • DrugVaxchora

    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.

05

What researchers measure

Primary outcomes

  1. Level of Antibody Titers in Serum

    Antibody response is evaluated as the level of antibody titers in serum. Higher vibriocidal antibody titers indicate greater protection against cholera.

    Time frame: Day 1 (pre-vaccination), Day 29

Secondary outcomes

  1. Plasmablast Levels

    Plasmablasts are collected via blood draw and isolated and assessed for counts by the study team.

    Time frame: Day 1 (pre-vaccination), Day 8, Day 29

  2. Activated B Cell Levels

    Activated B cells are collected via blood draw and isolated and assessed for counts by the study team.

    Time frame: Day 1 (pre-vaccination), Day 8, Day 29

  3. Memory B Cell Levels

    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.

    Time frame: Day 1 (pre-vaccination), Day 29

  4. Number of Monoclonal Antibodies Produced Per Participant

    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).

    Time frame: Day 8

  5. Number of Cholera Toxin B (CTB) Specific Monoclonals and Lipopolysaccharide (LPS) Specific Monoclonal Antibodies Per Participant

    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.

    Time frame: Day 8

  6. Number of Adverse Events

    The number of solicited and unsolicited adverse events were collected.

    Time frame: Up to Day 8, Up to Day 29

  7. Number of Serious Adverse Events

    The number of serious adverse events were collected during the duration of the study.

    Time frame: Up to Day 365

06

Results

Posted Feb 13, 2026

Participant flow

Participants were recruited at The Hope Clinic of Emory University in Atlanta, Georgia, USA. Participant enrollment began August 29, 2017 and follow up for the Day 29 study visit concluded on December 10, 2024.

Participant flow — Overall Study
MilestoneVaxchora Vaccination
Started34
Completed28
Not completed6
Withdrew: Lost to follow-up4
Withdrew: Withdrawal by subject2

Outcome measures

PrimaryLevel of Antibody Titers in Serum

Antibody response is evaluated as the level of antibody titers in serum. Higher vibriocidal antibody titers indicate greater protection against cholera.

Time frame:
Day 1 (pre-vaccination), Day 29
Reported as:
Mean · Vibriocidal antibody titer
Level of Antibody Titers in Serum
Vibriocidal antibody titerVaxchora Vaccination
Day 1, pre-vaccination76 ± 80.9
Day 292671 ± 2552.8
SecondaryPlasmablast Levels

Plasmablasts are collected via blood draw and isolated and assessed for counts by the study team.

Time frame:
Day 1 (pre-vaccination), Day 8, Day 29
Reported as:
Mean · percent of CD19+ lymphocytes
Plasmablast Levels
percent of CD19+ lymphocytesVaxchora Vaccination
Day 1, pre-vaccination2.0 ± 1.9
Day 85.3 ± 5.5
Day 291.2 ± 0.81
SecondaryActivated B Cell Levels

Activated B cells are collected via blood draw and isolated and assessed for counts by the study team.

Time frame:
Day 1 (pre-vaccination), Day 8, Day 29
Reported as:
Mean · percent of CD19+ lymphocytes
Activated B Cell Levels
percent of CD19+ lymphocytesVaxchora Vaccination
Day 1, pre-vaccination0.8 ± 0.6
Day 80.7 ± 0.5
Day 290.7 ± 0.6
SecondaryMemory B Cell Levels

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.

Time frame:
Day 1 (pre-vaccination), Day 29
Reported as:
Mean · % antigen specific cells/total cells
Memory B Cell Levels
% antigen specific cells/total cellsVaxchora Vaccination
Day 1, pre-vaccinationNA ± NA
Day 29NA ± NA
SecondaryNumber of Monoclonal Antibodies Produced Per Participant

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).

Time frame:
Day 8
Reported as:
Mean · monoclonal antibodies (mAbs)
Number of Monoclonal Antibodies Produced Per Participant
monoclonal antibodies (mAbs)Vaxchora Vaccination
Number of Monoclonal Antibodies Produced Per Participant24.83 ± 6.80
SecondaryNumber of Cholera Toxin B (CTB) Specific Monoclonals and Lipopolysaccharide (LPS) Specific Monoclonal Antibodies Per Participant

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.

Time frame:
Day 8
Reported as:
Mean · monoclonal antibodies (mAbs)
Number of Cholera Toxin B (CTB) Specific Monoclonals and Lipopolysaccharide (LPS) Specific Monoclonal Antibodies Per Participant
monoclonal antibodies (mAbs)Vaxchora Vaccination
Cholera Toxin B (CTB) specific monoclonals1.67 ± 2.34
Lipopolysaccharide (LPS) specific monoclonals9.17 ± 7.73
SecondaryNumber of Adverse Events

The number of solicited and unsolicited adverse events were collected.

Time frame:
Up to Day 8, Up to Day 29
Reported as:
Number · count of events
Number of Adverse Events
count of eventsVaxchora Vaccination
Days 1 - 877
Days 9 - 291
SecondaryNumber of Serious Adverse Events

The number of serious adverse events were collected during the duration of the study.

Time frame:
Up to Day 365
Reported as:
Number · count of events
Number of Serious Adverse Events
count of eventsVaxchora Vaccination
Up to Day 290
Day 30 to Day 3651

Adverse events

Collected over Information on adverse events was collected beginning at the baseline assessment and continued through Day 29 (for a total of 29 days). Information on serious adverse events was collected up to Day 365 (for a total of 365 days).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vaxchora Vaccination0/34 (0%)1/34 (2.9%)19/34 (55.9%)
Most frequent serious events
Most frequent serious events
EventVaxchora Vaccination
Hypertension urgencyCardiac disorders1/34
Most frequent other events
Most frequent other events
EventVaxchora Vaccination
HeadacheGeneral disorders11/34
DiarrheaGastrointestinal disorders9/34
FatigueGeneral disorders8/34
Nausea/vomitingGastrointestinal disorders6/34
Abdominal painGastrointestinal disorders6/34
Lack of appetiteGeneral disorders2/34
TachycardiaCardiac disorders1/34
BruiseSkin and subcutaneous tissue disorders1/34
GastritisGastrointestinal disorders1/34

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Vaxchora Vaccination
<=18 years0
Between 18 and 65 years34
>=65 years0
Age, Continuous
Age, Continuous(years)Vaxchora Vaccination
Mean33.9 ± 8.5
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Vaxchora Vaccination
Female17
Male13
Unknown/Not reported4
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Vaxchora Vaccination
Hispanic or Latino1
Not Hispanic or Latino33
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Vaxchora Vaccination
American Indian or Alaska Native1
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American11
White20
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Vaxchora Vaccination
United States34
07

Study locations

1 site
  • The Hope Clinic of Emory University
    Atlanta, Georgia 30030, United States
08

References and documents

Publications

  • Adekunle O, Dretler A, Kauffman RC, Cho A, Rouphael N, Wrammert J. Longitudinal analysis of human humoral responses after vaccination with a live attenuated V. cholerae vaccine. PLoS Negl Trop Dis. 2021 Sep 3;15(9):e0009743. doi: 10.1371/journal.pntd.0009743. eCollection 2021 Sep. PubMed 34478460 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 4, 2025
  • Informed consent form · Apr 11, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03251495
Lead sponsor
Emory University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Nadine Rouphael (Professor, Emory University) — Principal investigator
First posted
Aug 16, 2017
Start date
Aug 29, 2017
Primary completion
Dec 10, 2024
Completion
Nov 6, 2025
Results posted
Feb 13, 2026
Last update
Feb 13, 2026

Study contacts

Nadine Rouphael, MD
principal investigator · Emory University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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