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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05436444
Other study ID # 200160
Secondary ID 20-I-0160
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 23, 2023
Est. completion date October 31, 2024

Study information

Verified date March 29, 2024
Source National Institutes of Health Clinical Center (CC)
Contact Rani S Athota, Ph.D.
Phone (301) 594-0803
Email kotar@mail.nih.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Influenza, also called flu, is a virus. It can cause mild symptoms such as fever, cough, sore throat, and aches. Sometimes, flu can cause serious complications. Researchers want to see how people s immune systems respond to the flu. Objective: To find the smallest dose of influenza H10N7 virus that may cause an uncomplicated mild to moderate flu infection in healthy people. This dose will be used in the future to test how well new flu vaccines work. Eligibility: Healthy adults age 18-50. Design: Participants will be screened with: Physical exam with vital signs and weight Medical and medicine review Blood and urine tests Electrocardiogram to measure the heart s electrical activity. Screening tests will be repeated during the study. Participants will be tested for SARS-CoV-2 and other respiratory infections. For this, a swab will be inserted into the back of the nose. Participants will be admitted to an isolation room in the Clinical Center. They will stay in the hospital for at least 10 days. They will not have visitors. Participants may have a heart ultrasound. They may have lung function tests. For this, they will blow into a tube to measure lung capacity. One dose of the flu virus will be sprayed into participants nostrils. Participants will be monitored 24 hours a day. They will give nasal samples (using nasal washes and brushes) and blood samples almost every day. They will complete surveys about their symptoms. Participants will be discharged after they have 2 consecutive negative tests for flu. Participants will have at least 4 follow-up visits: 1 visit every 2 weeks for 8 weeks.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
A/Mallard/Ohio-99/MM4/1989 H10N7
The human challenge virus will be administered intranasally to each participant using a nasal atomizer. A total volume of up to 2 mL will be administered split between both nostrils of each participant.

Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Beare AS, Webster RG. Replication of avian influenza viruses in humans. Arch Virol. 1991;119(1-2):37-42. doi: 10.1007/BF01314321. — View Citation

KASEL JA, ALFORD RH, KNIGHT V, WADDELL GH, SIGEL MM. EXPERIMENTAL INFECTION OF HUMAN VOLUNTEERS WITH EQUINE INFLUENZA VIRUS. Nature. 1965 Apr 3;206:41-3. doi: 10.1038/206041a0. No abstract available. — View Citation

Memoli MJ, Czajkowski L, Reed S, Athota R, Bristol T, Proudfoot K, Fargis S, Stein M, Dunfee RL, Shaw PA, Davey RT, Taubenberger JK. Validation of the wild-type influenza A human challenge model H1N1pdMIST: an A(H1N1)pdm09 dose-finding investigational new drug study. Clin Infect Dis. 2015 Mar 1;60(5):693-702. doi: 10.1093/cid/ciu924. Epub 2014 Nov 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of MMID, defined as a positive FDA-approved clinical test for influenza plus one or more influenza symptoms, is induced. To determine the dose of A /Mallard/Ohio-99/MM4/1989 H10N7 human challenge virus that induces MMID in at least 60% of healthy volunteers. 9 days
Secondary Daily and total score on FLUPRO questionnaire and number and duration of symptoms and signs elicited by daily oral history and clinical exam To evaluate clinical disease, identify clinical markers, and observe initiation of shedding, length of shedding, and pathogenesis in participants 28 days
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