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Influenza A H3N2 Human Challenge Study in Healthy Adult Volunteers

NCT02594189 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-12-03

No results posted yet for this study

Summary

Background:

Influenza A H3N2 is a flu virus. Symptoms include fever, cough, and runny nose. It can also be more serious. Researchers want to know more about how influenza causes disease in people. They hope to develop new vaccines and treatments for flu infection.

Objective:

To find the smallest amount of Influenza A H3N2 virus that causes a mild to moderate flu infection in healthy people. Also, to study the body s immune response to this virus and how the infection develops.

Eligibility:

Healthy people ages 18 50 who are:

Non-smokers or non-habitual smokers

Willing to not smoke for at least 9 days

Design:

Participants will be screened under NIAID protocol #11-I-0183

Participants will stay at an isolation unit at the clinic for at least 9 days. They will remain in the isolation unit except for study-specific activities.

The influenza virus will be sprayed into the nose.

Participants will be monitored 24 hours a day. They will have tests, including:

Medical history

Physical exam

Daily questionnaires about symptoms

Blood and urine tests

Nasal wash and swab: A small tube of salt water is placed in the nose to wash it. It then collects the

fluid. Or the inside of the nose is rubbed with a swab.

ECG: Measures the heart s electrical signals

ECHO: Sound waves take pictures of the heart

PFTs/Spirometry: They will blow into a machine that measures the air they blow.

Participants will be discharged after they test negative for influenza A.

Participants will return to the clinic for 4 follow-up visits over 8 weeks. They may complete questionnaires at home.

Conditions

  • Determine Minimally to Moderately Infective Dose (MMID) of Influenza A H3N2

Interventions

OTHER

Live recombinantly derived A/Bethesda/MM1/H3N2 virus

The human challenge virus will be administered intranasally to each participant using a nasal sprayer. A total volume of up to 2mL of virus will be administered.

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
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-11-01
Completion
2017-11-01

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 NCT02594189 on ClinicalTrials.gov