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, 2025
Primary Completion Date
June 30, 2024
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
August 2022