Norwalk Vaccine Study

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Acute Gastroenteritis, Norwalk Virus Infection

In brief

The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during the inpatient stay.

Key facts

Study ID

NCT00973284

Run by

Takeda

People needed

98

Starts

2009-08-04

Expected to finish

2010-08-18

Last updated by the study team

2017-08-08

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Signed informed consents.
• Age 18 - 50 years, inclusive.
• Good general health as determined by a screening evaluation within 45 days of randomization.
• Expressed interest, availability, and understanding to fulfill the study requirements including measures to prevent Norwalk virus contamination of the environment and spread of infection and illness to the community. The prospective subjects must pass (> 75 % correct answers) a written examination on all aspects of the study before enrollment. (Appendix D)
• Available to return for follow-up visits following discharge from the inpatient unit and deliver stool specimens to the investigator promptly.
• Female subjects must be of non-childbearing potential, or if of childbearing potential (as determined by the investigator) must be practicing abstinence or using an effective licensed method of birth control (e.g. oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream, or foam; intrauterine contraceptive device, or Depo-Provera; skin patch; vaginal ring or cervical cap) for 30 days prior to vaccination and must agree to continue such precautions during the study and for 60 days after the Challenge visit. Male subjects must agree not to father a child during the study and for 60 days after the Challenge visit.
• Demonstrated to be H type-1 antigen secretor positive (by saliva test). [This saliva test may be done outside of the 45 day window and does not need to be repeated.]
• Agrees not to participate in another clinical trial with an investigational product for the entire duration of the study (six months after the last dose of study vaccine or placebo i.e. 201 days).

You may not qualify if…

• Living with or having daily contact with children age 5 years or less or a woman known to be pregnant. This includes significant contact at home, school, day-care, or equivalent facilities.
• Nursing mother.
• Living with or having daily contact with childcare workers.
• Living with or having daily contact with elderly persons aged 70 years or more, or infirmed, diapered individuals, persons with disabilities or incontinent persons. This includes work or visits to nursing homes and day-care or equivalent facilities.
• Evidence of recent (within 2 months) or of current nonbacterial gastroenteritis suggestive of Norwalk virus infection [vomiting or unformed or watery stools ( > 2 during a 24 hour period)].
• Any gastroenteritis within the past 2 weeks.
• History of chronic functional dyspepsia, chronic gastroesophageal reflux disease, peptic ulcer disease, gastrointestinal hemorrhage, gall bladder disease, inflammatory bowel disease, irritable bowel syndrome, frequent diarrhea, chronic constipation, or diverticulitis anytime during the subject's lifetime.
• Regular use of medication other than oral contraceptive agents, anti-hypertensives, anti-depressants, vitamins and minerals.
• History of any of the following medical illnesses:
• Chronic rhinitis, runny nose, sneezing (including seasonal allergies)
• Clinically significant nose bleed within the prior 12 months
• Diabetes
• Cancer (malignancies other than a resolved skin lesion)
• Heart disease (hospitalization for a heart attack, arrhythmia, or syncope)
• Unconsciousness (other than a single brief "concussion")
• Seizures (other than febrile seizures as a child <5 years old)
• Asthma requiring treatment with inhaler or medication in the prior 2 years
• Neuro-inflammatory disease
• Autoimmune disease
• Eating disorder
• Chronic headaches associated with vomiting
• Chronic vomiting syndrome
• Any current illness requiring daily medication other than vitamins, minerals, birth control, anti-depressants or anti-hypertensives.
• Blood Type B or AB. [This blood test may be done outside of the 45 day window and does not need to be repeated.]
• Allergies or hypersensitivity to chitosan, shrimp, other shellfish or any component of the vaccine or placebo.

Where it is running

• SNBL — Baltimore, Maryland, United States
• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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