Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-24 @ 7:33 PM
NCT ID:
NCT01322503
Eligibility Criteria:
Inclusion Criteria:
* Healthy adults between the ages of 18 and 49 years
* Willing and able to provide written informed consent
* Able to comply with all study procedures
* Have a body mass index of at least 19
* Have a serum IgG antibody titer of \< 1:1,600 to Norovirus
* Female subjects of child bearing potential must have negative urine pregnancy tests
* Female subjects must be of non-childbearing potential, or if of childbearing potential (as determined by investigator) must be practicing abstinence or using an effective licensed method of birth control for one month before receipt of challenge through one month after completing the inpatient isolation facility stay.
* Have normal screening laboratories
* Score at least 70% on a test of understanding of this research study.
Exclusion Criteria:
* Expected to be noncompliant with study procedures or planning to move within the anticipated total duration of the study
* Pregnant or breastfeeding
* HIV, Hepatitis B or C positive
* Norovirus antibody screening titer of \> 1:1600
* Clinically significant findings on history or physical examination
* Clinically significant history of diseases or treatments that may affect the immune system's function
* Receipt of systemic corticosteroids for greater than 7 days within the past six months
* Abnormal screening electrocardiogram (ECG)
* Clinically significant respiratory disease, endocrine disease, liver disease, renal disease, or neurological disease
* History of malabsorption or maldigestion disorder, major gastrointestinal (GI) surgery, or any other chronic GI disorders that would interfere with the study
* Clinically significant abnormalities of the health screening laboratory work
* Use of antibiotics within 7 days prior to entry into the inpatient isolation facility (Day -1)
* Any medical illness requiring a new prescription medication or hospitalization during the screening period
* Temperature ≥38.0°C
* Diarrhea or vomiting during the 7 days prior to challenge administration
* Allergy to sodium bicarbonate solution
* Treatment within the past year for an eating disorder
* History of alcohol or drug abuse within past 3 years
* Receipt of any vaccine, licensed or investigational, or any investigational product within 30 days of challenge administration or plan to receive any vaccine or investigational product through the study duration
* Use of any H2 receptor antagonists or prescription acid suppression medication or over-the-counter (OTC) antacids within 72 hours of investigational product administration (Day 0)
* Use of prescription and OTC medications containing acetaminophen, aspirin, ibuprofen, and other non-steriodal anti-inflammatory drugs within 48 hours prior to investigational product administration
* Regular use of laxatives or anti-motility agents
* Receipt of blood or blood products within the past six months
* Subjects who are unwilling or unable to cease smoking for the duration of the inpatient stay
* Any other condition, such as a medical, psychiatric, or social condition or occupational responsibility that, in the judgment of the investigator, would interfere with or serve as a contraindication to the subject's participation in the study or assessment of the investigational product
* Plan to be living in a confined environment within 3 weeks after receiving the challenge strain
* Commercial food handlers, day care workers, or health care workers involved in direct patient contact
* Provide child day care services either in a home or in a nonresidential facility
* Provide direct care to individuals over 65 years of age, young children (\<2 years) at home or with household contacts who are:
* Immunocompromised
* Pregnant, or
* Breast feeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT01322503
Study Brief:
Protocol Section:
NCT01322503