Phase I Study to Determine the Optimal Human Challenge Dose for a Norovirus GII.4 Challenge Stock (CIN-1)

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Gastroenteritis Norovirus

In brief

This is phase I, double blind, placebo-controlled safety and infectivity study of experimental human Norovirus genogroup GII.4 administered to healthy adults 18-49 years of age. Subjects susceptible to the human norovirus GII.4 challenge strain. The challenge study will be conducted in 2-3 cohorts of approximately 20 subjects each.Subjects will remain in the inpatient facility for at least four days following challenge and assessed daily for clinical and virologic evidence of norovirus infection. The primary objectives are to evaluate the safety and reactogenicity of the norovirus GII.4 (CIN-1; 031693) challenge stock and to determine a safe and optimal challenge dose of Norovirus GII.4 Challenge Stock norovirus to achieve illness in \> /=50% of subjects. Illness is defined as: diarrhea (\>3 loose or liquid stools or \>300 gm of loose or liquid stool /24h), and/or vomiting during the inpatient period, in a participant with evidence of infection.

Key facts

Study ID

NCT02337842

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

0

Starts

2015-09-01

Expected to finish

2016-01-01

Last updated by the study team

2016-06-03

Who can join

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

You may qualify if…

• Subjects must meet all of the following inclusion criteria:
• Subject able to provide written informed consent.
• Male or non-pregnant females between the ages of 18 and 49 years, inclusive.
• Women of childbearing potential must be practicing abstinence or using an acceptable method of birth control for at least 30 days prior to enrollment through day 45 after receipt of the challenge virus. Male subjects must agree not to father a child prior to day 45 after receipt of the challenge virus.
• A woman is considered of childbearing potential unless post-menopausal (absence of menses for >/= 1 year) or surgically sterilized (tubal ligation, bilateral oophorectomy or hysterectomy).
• Acceptable contraception methods for women include but are not limited to: sexual abstinence from intercourse with men, monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject enrolling in the study, barrier methods such as condoms or diaphragms with spermicide or foam, effective devices (IUDs, NuvaRing®) or licensed hormonal products such as implants, injectables or oral contraceptives.
• For women of childbearing potential, must have a negative serum or urine pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to challenge.
• Are in good general health, as determined by the study investigator within 60 days of challenge.
• Demonstrate knowledge and comprehension of the study by scoring >/=70 procent on a quiz of the study protocol and policies.
• Willing and able to participate in all study visits, including an inpatient stay of at least 96 hours.
• Demonstrated to be secretor positive for HBGA binding.

You may not qualify if…

• Subjects who meet any of the following exclusion criteria will be excluded from study participation:
• Have household contact with or have daily contact with children less than 2 years of age or persons older than 70 years of age.
• Have expected occupational or social contact with immunocompromised individuals in the 8 weeks after challenge, including persons with HIV infection or active cancer, children < 2 years of age, pregnant women or persons who are immunosuppressed (e.g. history of stem cell or organ transplantation) and/or provide any child day care services (in-home or non-residential facility).
• Are healthcare workers with patient contact in the 8 weeks after challenge.
• Are food service workers expected to prepare/handle food in the 8 weeks after challenge.
• Plan to be living in a confined environment (e.g. ship, camp, or dormitory) within 8 weeks after receiving the challenge strain.
• For females, are pregnant or plan to become pregnant at any time between the Screening Visit through 45 days after receipt of the challenge virus.
• Are breastfeeding or plan to breastfeed at any given time throughout the study.
• Have a history of gastroenteritis in the 4 weeks prior to challenge or any history of chronic or recurrent diarrhea or vomiting.
• Have a history of malabsorption or maldigestion disorder (e.g. celiac sprue), major gastrointestinal (GI) surgery, irritable bowel syndrome or any other chronic GI disorders that would interfere with the study, including chronic constipation or increased stool frequency.
• Have moderate or severe illness and/or an oral temperature >/=100.4 degre Fahrenheit and/or diarrhea or vomiting within seven days prior to challenge.
• Have a pulse rate less than 55 bpm or greater than 100 bpm. If heart rate is <55 beats per minute and the investigator determines that this is not clinically significant (e.g., athletes) and heart rate increases > 55 beats per minute on moderate exercise (two flights of stairs), subject will not be excluded.
• Have a systolic blood pressure less than 90 mm Hg or greater than 140 mm Hg on two separate measurements (screening and pre-challenge).
• Have a diastolic blood pressure less than 50 mm Hg or greater than 90 mmHg on two separate measurements (screening and pre-challenge).
• Have long-term use (>/=2 weeks) of high-dose oral (>/= 20 mg per day prednisone or equivalent) or parenteral glucocorticoids, or high-dose inhaled steroids for greater than 7 days in the last 6 months.
• Have an autoimmune, inflammatory, vasculitic or rheumatic disease, including but not limited to systemic lupus erythematosus, polymyalgia rheumatic, rheumatoid arthritis or scleroderma.
• Have HIV, Hepatitis B, Hepatitis C infection or untreated latent syphilis.
• Have a seizure disorder.
• Have an active malignancy or history of malignancy (excluding nonmelanotic skin cancer in remission without treatment for more than 5 years) or current use of immunosuppressive or cytotoxic therapy.
• Have positive fecal culture for E. coli O157:H7, Salmonella, Campylobacter, Yersinia, or Shigella, evidence of norovirus in the stool by RT-qPCR or pathogenic ova and parasites detected on microscopic examination at screening.
• Have abnormal screening laboratory test results per laboratory reported normal values and Section 18 Appendix B for white blood cells (WBCs), hemoglobin (Hgb), platelets, absolute neutrophil count (ANC), bilirubin, potassium, sodium, Hemoglobin A1-c (HgbA1-c) and urine protein.
• Serum creatinine greater than 1.1 x ULN
• Alanine aminotransferase (ALT), greater than 1.1 x ULN.
• Have a chronic condition that the study physician feels would pose a threat to participating subjects, including, but not limited to solid organ or stem cell transplantation, diabetes, clinically significant history of immunosuppressive illness, gall bladder disease, heart disease, lung disease, pancreatic disease, renal disease or neurological disease.
• Have abnormal findings on screening electrocardiogram deemed clinically significant by study physician.

Where it is running

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

Full record on ClinicalTrials.gov

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