The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral vaccine) is safe and effective in the prevention of Shigella infection.
There are two purposes for conducting this Vaccine Study to evaluate an experimental vaccine called CVD 1208S (Center for Vaccine Development 1208S): 1) to learn whether CVD 1208S causes side effects, and 2) to learn whether the CVD 1208S gives people immunity to Shigella.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
26
The vaccine is mixed with salt water and given by mouth.
Corn starch and baking soda are mixed with salt water and given by mouth.
Shin Nippon Biomedical Laboratories, LTD. (SNBL) Inpatient Facility
Baltimore, Maryland, United States
University of Maryland, Baltimore Center for Vaccine Development
Baltimore, Maryland, United States
Number of participants with reactions and adverse events
occurence of diarrhea, dysentery and fever.
Time frame: Reactions are evaluated for 7 days after each dose. Adverse events are evaluated for the entire study participation (6 months for cohort 1 and 8 months for all other cohorts).
Number of participants who receive the vaccine who get immunity to shigella
It is hoped that the vaccine will trigger the body's immune system to make specific responses such as antibodies (special proteins) and antibody-producing cells that are believed to protect against illness if a person is exposed to certain illness-causing Shigella in the future.
Time frame: Immunity in the blood will be assessed using serial samples collected during the 84 days after the first vaccination. Immunity at the intestinal level will be assessed by collecting seral stool samples for 14 days after each vaccination.
Number of participants who pass the vaccine in their stool
Volunteers' stool will be tested to see if the vaccine is present. This will tell whether the vaccine is able to stick to the intestine and grow there. We will see whether this information predicts the strength of the immune responses to the vaccine and whether the vaccine could potentially be passed to close contacts.
Time frame: The first 84 days after vaccination
The number of participants who develop various types of immune responses
We will look at the ability of the vaccine to evoke different types of responses in blood and stool that might protect them against Shigella infections in the future.
Time frame: The first 84 days of the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.