Susceptibility of Human Volunteers With Different Histo-Blood With Different Histo-Blood Group Antigens to Norovirus

Completed · Phase 1

Conditions studied: Healthy Adults

In brief

Objectives: To evaluate the role of human histo-blood group antigens in susceptibility to Norovirus infections. Description of Study Design: Healthy volunteers with different blood types and low antibody titers to the challenge strain will be challenged orally with a Norovirus in the CCCR inpatient facility. Subjects with resistant (non-secretors) or susceptible (secretors (of either A, B or O blood group)) to the challenge strain will be recruited. The challenge study will be conducted in two groups of twenty, each with approximately ten secretors and ten non-secretors. Three additional subjects per group will serve as alternates in the event that any of the study subjects are unavailable or become ineligible at the time of the inpatient study. Subjects will be monitored daily in the isolation facility for at least five days following this challenge for daily clinical and virological evaluations. Subjects will return to the investigational site for evaluation the day after discharge from the inpatient unit and about 30 days (28-35 days) post challenge. Study Endpoints: Norovirus infection as assessed by viral shedding, seroconversion and clinical illness assessed by the duration and severity of symptoms

Key facts

Study ID

NCT01322503

Run by

Children's Hospital Medical Center, Cincinnati

People needed

40

Starts

2010-10-01

Expected to finish

2011-03-01

Last updated by the study team

2012-02-10

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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