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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01322503
First received: October 25, 2010
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Healthy Adults
Biological: Norovirus
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Evaluation of the Susceptibility of Human Volunteers With Different Histo-Blood Group Antigens to Norovirus

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Measurement of the number of people who develop symptomatic illness after challenge with Norovirus [ Time Frame: 1 month after challenge ] [ Designated as safety issue: Yes ]

    The number of subjects that become infected, as measured by the number of subjects found to be shedding norovirus in their stool, as well as the number of symptomatic infections (viral shedding in addition to other symptoms such as vomiting, diarrhea, abdominal cramps) will be the primary outcome measure.

    We will also assess the number of subjects who show at least a 4-fold rise in antibodies against Norovirus (comparing pre-challenge and post-challenge antibody levels).



Enrollment: 40
Study Start Date: October 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Norovirus Challenge Biological: Norovirus
Norovirus challenge pool administered to each subject
Other Name: Norovirus challenge pool
Experimental: Norovirus challenge Biological: Norovirus
Norovirus challenge pool administered to each subject
Other Name: Norovirus challenge pool

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322503

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Robert Frenck, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided by Children's Hospital Medical Center, Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01322503     History of Changes
Other Study ID Numbers: PR033018
Study First Received: October 25, 2010
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Disease Susceptibility
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014