Immunologic Responses to a Live Attenuated Oral Cholera Vaccine

Emory University

Status and phase

Active, not recruiting

Phase 2

Conditions

Cholera

Treatments

Drug: Vaxchora

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03251495

IRB00097012

R01AI137127 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment

34 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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
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