Immunologic Responses to a Live Attenuated Oral Cholera Vaccine (NCT03251495) | Clinical Trial Compass
CompletedPhase 2
Immunologic Responses to a Live Attenuated Oral Cholera Vaccine
United States34 participantsStarted 2017-08-29
Plain-language 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.
Who can participate
Age range18 Years – 49 Years
SexALL
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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 bl…