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

NCT01322503 | Completed Phase 1

• 1 other identifier: PR033018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Measurement of the number of people who develop symptomatic illness after challenge with Norovirus

  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).

  1 month after challenge

Study Arms (2)

Norovirus Challenge

EXPERIMENTAL

Biological: Norovirus

Norovirus challenge

EXPERIMENTAL

Biological: Norovirus

Interventions

Norovirus BIOLOGICAL

Norovirus challenge pool administered to each subject

Also known as: Norovirus challenge pool

Norovirus Challenge; Norovirus challenge

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• United States Department of Defense: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Frenck R, Bernstein DI, Xia M, Huang P, Zhong W, Parker S, Dickey M, McNeal M, Jiang X. Predicting susceptibility to norovirus GII.4 by use of a challenge model involving humans. J Infect Dis. 2012 Nov;206(9):1386-93. doi: 10.1093/infdis/jis514. Epub 2012 Aug 20.

  PMID: 22927452 DERIVED

Study Officials

• Robert Frenck, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: March 24, 2011
• Study Start: October 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 10, 2012

Record last verified: 2012-02

Locations

US (1)