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

This is an interventional prevention trial for Shigella focused on measuring Shigella, Vaccine, Mucosal immunity Read More

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.