Baltimore, Maryland 21201

  • Shigella

Purpose:

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.


Study 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.


Criteria:

Inclusion Criteria: - Age 18 to 45 years, inclusive. - Good general health - Expressed interest and availability to fulfill study requirements - Informed, written consent. - Agrees to indefinite storage of unused clinical specimens at the CVD for use in future research - Agrees not to participate in another investigational vaccine or drug trial during the study - Has no childbearing potential or agrees to abstain from becoming pregnant from the day of screening (at least 14 days before vaccination) until 6 weeks after the final vaccination by using birth control - Agrees not to donate blood to a blood bank for 12 months after receiving the vaccine. Exclusion Criteria: - An acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. - Any current illness requiring daily medication (vitamins, birth control pills, nasal or topical medications, allowed); - Blood in stool on >2 occasions (other than small amounts from straining) in past 12 months; - Recurrent diarrhea (>5 episodes in past 6 months, each lasting 3 days or more). - Immunosuppression - Long term (greater than 2 weeks) use of oral or injected steroids, or high-dose inhaled steroids (>800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed). - History of abdominal surgery - Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. - Known allergy or intolerance to ciprofloxacin, trimethoprim/sulfamethoxazole (or other sulfa antibiotic), ampicillin (for women) or corn. - History of shigellosis or Shigella vaccination or challenge or a laboratory worker with known exposure to Shigella. - Anticipates any of the following during the first 84 days (12 weeks) of the study (28 days, or 4 weeks for Cohort 1): - Shares a household with a child <3 years of age, a pregnant woman or a woman who plans to become pregnant during this time; - Household or sexual contact with someone who has weakened immunity (such as someone with HIV infection, someone receiving treatment for cancer, or an elderly person > 70 yrs); - Occupation as a food-handler, childcare (for children <3 years), or health care worker with direct patient contact. - A clinically significant abnormality on physical examination - Results of blood tests as defined by protocol - Positive pregnancy test during medical screening or within 24 hours of inoculation or current breast feeding (women). - Failure to attain a score of at least 70% on the written examination (two attempts permitted) - During the past 3 years, developed diarrhea during travel to a developing country, or within 1 week of returning home. - Receipt of any of the following: - Any vaccine or investigational drug within 30 days of study vaccine - A live, attenuated vaccine within 30 days of the study vaccine - A subunit or killed vaccine within 14 days of the study vaccine - A blood product in the 90 days before the study vaccine - Receipt of antibiotics within 7 days of inoculation (or within 21 days if the antibiotic was azithromycin). - Loose stools or any other acute illness such as fever >100.0 degrees F during the 48 hours before vaccination.


NCT ID:

NCT01531530


Primary Contact:

Principal Investigator
Karen L. Kotloff, M.D.
University of Maryland,Baltimore Center for Vaccine Development


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 23, 2021

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