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Norovirus InfectionsPhase 1CIN-002NCT01435811

Dose Range Evaluation of Norovirus Challenge Pool (GII.4, CIN-1)

A Phase 1 study testing Norovirus challenge pool (GII.4, CIN-1) in people with Norovirus Infections, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine a suitable dose of the human norovirus GII.4 challenge pool(CIN-1;031693) that induces illness in approximately 50% of susceptible subjects that would be useful for evaluation of vaccines and antivirals. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Norovirus Infections
What is being tested?
Norovirus challenge pool (GII.4, CIN-1)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
Aug 2011to Nov 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 serum antibody titer of < 1:1600 to the GII.4 challenge strain of Norovirus as measured by ELISA
  • Female subjects of childbearing potential must have negative urine pregnancy tests, at screen and prior to challenge
  • 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 (e.g. oral contraception; diaphragm or condom in combination with contraceptive jelly, cream, or foam; intrauterine contraceptive device, or hormonal devices/injections (for example, NORPLANT® or DEPO-PROVERA®) from screening through one month after completing inpatient stay.
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  • Have normal screening laboratories for SGPT (ALT), creatinine, sodium, potassium, total white blood cell count (WBC), hemoglobin, neutrophils, lymphocytes, platelets, urine protein, urine glucose and urine RBCs (see table below) as well as negative stool culture for known bacterial pathogens and stool evaluation for parasites.
  • For challenged subjects: Be secretor positive for HBGA binding by assay of their saliva. For placebo recipients: Be secretor negative for HBGA binding by assay of their saliva.
  • Score at least 70% on a test of understanding of this research study.

Who cannot join

  • Expected to be noncompliant with study procedures or planning to move within the anticipated total duration of the study (180 days after challenge)
  • Pregnant or breastfeeding
  • HIV positive (by history or screening antibody test)
  • Hepatitis B positive (by history or a positive hepatitis B surface antigen)
  • Hepatitis C positive (by history or a positive antibody to hepatitis C virus)
  • Norovirus GII.4 serum antibody screening titer of > 1:1600
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  • Clinically significant findings on history or physical examination
  • Temperature >38.00C, resting heart rate >100/beats per minute or <55/beats per minute, systolic blood pressure >140, diastolic blood pressure >90, systolic blood pressure <90, respiratory rate >16/min. If heart rate <55 beats per minute and investigator determines that this is not clinically significant and heart rate increases > 55 beats per minute on moderate exercise (two flights of stairs), subject will not be excluded. Vital signs may be repeated at screening.
  • Clinically significant history of diseases or treatments that may affect the immune system's function such as a past history of cancer, receipt of chemotherapy or radiation therapy, or autoimmune diseases (exception; a history of basal cell or squamous cell carcinoma in remission without treatment for more than 5 years prior to study entry)
  • Receipt of systemic corticosteroids for greater than 7 days within the past six months
  • Clinically abnormal screening electrocardiogram (ECG) defined as pathologic Q waves and significant ST-T wave changes: criteria for left ventricular hypertrophy; and any non-sinus rhythm excluding isolated premature atrial contractions
  • Clinically significant respiratory disease, endocrine disease, liver disease, renal disease, or neurological disease
  • History of malabsorption or maldigestion disorder (e.g. celiac sprue), 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 facility (Day -1)
  • Any chronic medical illness requiring a new prescription medication or hospitalization during the screening period.
  • Temperature ≥38.0°C or self-reported diarrhea or vomiting during the 7 days prior to challenge administration (Day 0)
  • History of treatment within the past year for an eating disorder
  • Self-reported 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 up to one month after leaving the inpatient facility
  • Use of any H2 receptor antagonists (e.g., Tagamet, Zantac, and Pepcid), proton pump inhibitors (e.g., Prilosec, OTC, Protonix, and Prevacid), 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-steroidal anti-inflammatory drugs within 48 hours prior to investigational product administration (Day 0)
  • 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 (e.g. ship, camp, or dormitory) 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
  • Subjects with young children (<2 years) at home or with household contacts who are:
  • Immunocompromised
  • Pregnant, or
  • Breast feeding

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

The purpose of this study is to determine a suitable dose of the human norovirus GII.4 challenge pool(CIN-1;031693) that induces illness in approximately 50% of susceptible subjects that would be useful for evaluation of vaccines and antivirals.

Being tested
Norovirus challenge pool (GII.4, CIN-1)
Keywords
Norovirus
Medical subject headings
Caliciviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Norovirus challenge pool (GII.4, CIN-1)Biological

    Norovirus challenge pool (GII.4, CIN-1)

Study groups in NCT01435811
Study groupRoleWhat they receive
Norovirus challenge pool (GII.4, CIN-1)ExperimentalNot described
Receives: Biological: Norovirus challenge pool (GII.4, CIN-1)
Sterile waterPlacebo comparatorNot described
Receives: Biological: Norovirus challenge pool (GII.4, CIN-1)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose range evaluation of Norovirus challenge pool (GII.4, CIN-1)

    To determine a suitable dose of the human norovirus GII.4 challenge pool (CIN-1;031693) that induces illness in approximately 50% of susceptible subjects that would be useful for evaluation of vaccines and antivirals.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionApr 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01435811
Sponsor's protocol ID
CIN-002
Acronym
CIN-002
Status last verified
May 2014
First submitted
15 Sep 2011
Last updated
7 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Norovirus challenge pool (GII.4, CIN-1) in people with Norovirus Infections, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose range evaluation of Norovirus challenge pool (GII.4, CIN-1) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01435811.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.

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