CVD 909 Vi Prime Boost Study

Completed · Phase 1 · Has a placebo group

Conditions studied: Typhoid Fever

In brief

The purpose of this research study is to see if giving a typhoid vaccine by mouth (an experimental vaccine, CVD 909) before giving a vaccine shot (Typhim Vi) will result in a better immune response than giving Typhim Vi vaccine by itself. Another purpose is to see whether CVD 909 is safe. Typhim Vi has been shown to be safe and effective in preventing typhoid fever in older children and adults, but it does not work in children under age 2. Scientists at the University of Maryland think that young children could respond to Typhim Vi if they were given a dose of the other typhoid vaccine by mouth before they are given the Typhim Vi shot. Twenty-eight healthy adult volunteers, ages 18-40 years, will take part in this study. Study participation will last for up to 63 weeks, but most of the study visits will be in the first 6 weeks. Blood samples will be collected approximately 13 times. Four stool samples will be collected. Some volunteers may be followed for an additional 4 years.

Key facts

Study ID

NCT00326443

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

21

Starts

2006-02-01

Expected to finish

2008-08-01

Last updated by the study team

2014-05-09

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 - 40 years, inclusive.
• Good general health as determined by a screening evaluation within 30 days before administration of CVD 909 or placebo.
• Expressed interest and availability to fulfill the study requirements.
• Informed, written consent.
• Agrees not to participate in another investigational vaccine or drug trial for the first 84 days of this study.
• Agrees not to become pregnant from the time of study enrollment until at least 56 days after the administration of CVD 909 or placebo; if a woman is sexually active and capable of conception (i.e., no history of hysterectomy or tubal ligation), she must agree to use hormonal or barrier birth control. A woman is eligible if she is monogamous with a vasectomized male.

You may not qualify if…

• History of any of the following medical illnesses:
• Gall bladder disease or gall stones without cholecystectomy
• Diabetes
• Cancer
• Heart disease (hospitalization for a heart attack, arrhythmia, or syncope)
• Unconsciousness
• Seizures (other than febrile seizures as a child less than 5 years old)
• Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
• Any current illness requiring daily medication other than vitamins, birth control, or stable regimen of anti-histamine medication for hay fever or anti-depressant
• 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, Caesarean section, appendectomy, or herniorrhaphy) within the last 3 years
• Laparoscopic abdominal surgery within the past year
• A large abdominal scar of unclear origin
• Evidence of gastrointestinal disease, as indicated by any of the following:
• Usual bowel habit of more than 3 bowel movements each day
• Recurrent diarrhea (greater than 5 episodes during the past 6 months, each lasting at least 3 days, with at least one week between episodes)
• Lactose intolerance
• Frequent indigestion or heartburn that requires daily antacids or other medical therapy
• Diagnosed by a doctor as having irritable bowel disease, Crohn's disease, ulcerative colitis, celiac disease, stomach or intestinal ulcers in the past 10 years
• Blood in the stool during the past year (other than occasional small amount from straining)
• Any clinically significant abnormality detected on physical examination, including:
• Murmur (other than a functional murmur)
• Focal neurological deficit suggesting a pathologic process
• Hepatosplenomegaly

Where it is running

• University of Maryland Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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