Cholera vaccine vaxchora put to the test in immune response study
NCT ID NCT03251495
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested the oral cholera vaccine Vaxchora in 34 healthy adults to see how well it triggers protective antibodies and immune cells. Participants received a single dose, and researchers measured antibody levels, B cells, and T cell responses. The goal is to understand the vaccine's immune effects and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vaxchora (live attenuated oral cholera vaccine)
- What this could lead to
- If successful, this study could confirm that Vaxchora produces strong immune memory, supporting its use for cholera prevention.
- What could go wrong
- This is a small, early-phase study with only 34 healthy adults, so results may not apply to broader populations. The vaccine may not provide long-lasting protection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
34 people
The number who actually took part.
- Started
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Aug 2017
- Finished
-
Nov 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 49 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The Hope Clinic of Emory University
Atlanta, Georgia, 30030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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