Immunologic Responses to a Live Attenuated Oral Cholera Vaccine

• Status: Suspended
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Treatments: Vaccines

Criteria

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

• Travelled 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 EGD/biopsies.

• BMI > 35 kg/m2

• 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