Immunologic Responses to a Live Attenuated Oral Cholera Vaccine

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®).

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 cholera infection

- 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 workers who have direct contact with children who are 2 years or younger

- Are workers in the food industry

- Have received any vaccine within the previous 21 days