Status:
COMPLETED
CVD 909 Vi Prime Boost Study
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Typhoid Fever
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
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 th...
Detailed Description
This is a phase I, randomized, double-blind, heterologous prime-boost study of the safety and immunogenicity of Vi polysaccharide typhoid vaccine after priming by live, attenuated oral Vi+ Salmonella ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Lymphadenopathy
- Jaundice
- Hypertension (BP greater than 150/90 mm Hg on two separate days) or hypotension (BP less than 85/55 mm Hg)
- Any lab abnormality, as listed below:
- WBC outside the normal range
- Hemoglobin outside the normal range
- Platelet count outside the normal range
- Creatinine outside the normal range
- Fasting glucose greater than 115 mg/dl (if screening greater than 115 mg/dl)
- AST or ALT outside the normal range (may be repeated once if outside this limit)
- Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen
- Stool culture positive for Salmonella spp, Shigella spp, Campylobacter jejuni, V. cholerae, or pathogenic protozoa
- For women, positive serum pregnancy test within 7 days and urine pregnancy test within 24 hours of administering CVD 909 and within 24 hours of administering Vi vaccine
- Nursing mother
- Oral temperature greater than 37.8ºC or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis on the day of administration of CVD 909 or placebo
- Immunization against typhoid fever or history of typhoid fever
- Allergy to quinolones (including ciprofloxacin) or sulfa drugs (Including trimethoprim/sulfamethoxazole)
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
- Failure to pass written examination about study purpose, background, and procedures (70% correct answers required to pass)
- Receipt of an investigational vaccine or drug within 28 days before administration of CVD 909
- Commercial food-handlers
- Health care workers who are engaged in patient care during the study
- Day care providers
- Subject with a household contact who is less than 2 years of age, who is immunocompromised or pregnant, or who works as a commercial food-handler
- Use of antibiotics within 7 days of CVD 909 or placebo vaccination
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00326443
Start Date
February 1 2006
End Date
August 1 2008
Last Update
May 9 2014
Active Locations (1)
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1
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201