Clinical Trial: Safety and Efficacy Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella Infection Using cGMP

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety, Clinical Tolerance, and Immunogenicity of CVD 1208S, a Delta guaBA, Delta Sen, Delta Set, Live, Oral Shigella Flexneri 2a Vaccine Manufactured Using cGMP

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Maryland

Current Primary Outcome:

• Number of participants with reactions and adverse events [ 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). ]
  occurence of diarrhea, dysentery and fever.
• Number of participants who receive the vaccine who get immunity to shigella [ 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. ]
  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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of participants who pass the vaccine in their stool [ Time Frame: The first 84 days after vaccination ]
  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.
• The number of participants who develop various types of immune responses [ Time Frame: The first 84 days of the study ]
  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.

Original Secondary Outcome: Same as current

Information By: University of Maryland

Dates:
Date Received: October 26, 2011
Date Started: July 2011
Date Completion:
Last Updated: January 14, 2013
Last Verified: January 2013