Safety and Efficacy Challenge Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella: Phase IIb

Stopped early · Phase 2

Conditions studied: Shigella

In brief

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.

Key facts

Study ID

NCT00866242

Run by

University of Maryland, Baltimore

People needed

20

Starts

2010-01-01

Expected to finish

2010-02-01

Last updated by the study team

2021-04-29

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 to 45 years, inclusive
• Good general health as determined by a screening evaluation within 45 days before inoculation
• 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, which may require separate IRB approval
• Agrees not to participate in another investigational vaccine or drug trial during the 6-month study
• Has no childbearing potential, i.e., either surgically sterilized or 1 year postmenopausal, or agrees to abstain from becoming pregnant from the day of screening (at least 14 days before vaccination) through Day 42 of the trial by using one of the following methods of birth control:
• Abstinence
• Intrauterine contraceptive device
• Oral contraceptives or equivalent hormonal contraception, e.g., progestogen-only implantable, cutaneous hormonal patch, injectable contraceptives, or Nuvaring (vaginal hormonal ring)
• Diaphragm in combination with contraceptive jelly, cream, or foam
• Condoms with spermicide

You may not qualify if…

• 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. This includes, but is not limited to:
• Chronic liver disease, renal insufficiency, unstable or progressive neurological disorders, diabetes mellitus, collagen vascular disease (such as lupus), active neoplastic disease (not cured or in remission), or previous hematological malignancy
• Repeated (two or more) seizures occurring after 5 years of age, and not related to a concussion
• Any of the following in the past 10 years: Crohn's disease, ulcerative colitis, irritable bowel disease, celiac disease, stomach or intestinal ulcers, or 2 or more episodes of arthritis (joint pain and swelling);
• Recurrent infections (more than 1 hospitalization for invasive bacterial infections, e.g., pneumonia, meningitis)
• G6PD deficiency
• Any current illness requiring daily medication (vitamins, birth control pills, nasal or topical medications, allowed)
• Blood in stool on more than 2 occasions (other than small amounts from straining) in past 12 months
• Recurrent diarrhea (more than 5 episodes in past 6 months, each lasting 3 days or more)
• Immunosuppression as a result of an underlying illness or treatment within the preceding 36 months,
• long term use of steroids, or high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed)
• History of the following types of abdominal surgery:
• Any major gastrointestinal surgery (e.g., intestinal resection or splenectomy)
• A laparotomy for any reason (e.g., hysterectomy, Caesarian section, appendectomy, or herniorrhaphy) within the last 3 years
• Laparoscopic abdominal surgery within the past year
• A large abdominal scar of unclear origin
• 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) or ampicillin (for women)
• History of shigellosis or Shigella vaccination (except as a participant in Part A of this study) or challenge or a laboratory worker with known exposure to Shigella
• During the past 3 years, developed diarrhea during travel to a developing country, or within 1 week of returning home
• Anticipates any of the following during 30 days after discharge from the Isolation Ward:
• Shares a household with a child less than 3 years of age, a pregnant woman, or a woman who plans to become pregnant during this time period
• 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 greater than 70 years)
• Occupation as a food-handler, childcare (for children less than 3 years), or health care worker with direct patient contact
• Poor peripheral access for placement of an intravenous line

Where it is running

• Shin Nippon Biomedical Laboratories (SNBL) Inpatient Facility — Baltimore, Maryland, United States
• University of Maryland, Baltimore Center for Vaccine Development — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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