Immunologic Responses to a Live Attenuated Oral Cholera Vaccine

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Brief Title

Immunologic Responses to a Live Attenuated Oral Cholera Vaccine

Official Title

Immunologic Responses to a Live Attenuated Oral Cholera Vaccine

Brief 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.
    

Detailed Description

      Cholera is a life-threatening illness that causes diarrhea. Cholera is caused by eating or
      drinking the Vibrio cholera bacteria. Each year, there are about 1.3 to 4.0 million cases of
      cholera worldwide, resulting in 21,000 to 143,000 deaths. The bacteria is spread through
      water or food that has stool in it. Up to 50 countries with limited access to clean water are
      more likely to have outbreaks. In the United States most cases are linked to travel to these
      countries; however, there are 10-15 cases acquired in the United States each year because of
      undercooked seafood. Cholera spreads very easily. Illness from Cholera can vary from no
      symptoms to severe watery diarrhea that can cause death by dehydration in a healthy person
      within hours.

      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®).
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percentage of Positive Responders

Secondary Outcome

 Plasmablast Levels

Condition

Cholera

Intervention

Vaxchora

Study Arms / Comparison Groups

 Vaxchora Vaccination
Description:  Healthy subjects will receive a single dose of oral live cholera vaccine.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

August 29, 2017

Completion Date

June 30, 2023

Primary Completion Date

July 30, 2022

Eligibility 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
      

Gender

All

Ages

18 Years - 49 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Nadine Rouphael, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03251495

Organization ID

IRB00097012


Responsible Party

Principal Investigator

Study Sponsor

Emory University


Study Sponsor

Nadine Rouphael, MD, Principal Investigator, Emory University


Verification Date

May 2022