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Low Pathogenicity Avian H10N7 Influenza Virus in a Healthy Human Challenge Model

NCT05436444 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • Influenza Infection

Interventions

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Matthew J Memoli, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-23
Primary Completion
2024-12-17
Completion
2024-12-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05436444 on ClinicalTrials.gov