NCT02594189|CompletedPhase 1

Influenza A H3N2 Human Challenge Study in Healthy Adult Volunteers

National Institute of Allergy and Infectious Diseases (NIAID)ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

160008

Secondary identifiers

16-I-0008

Study Type

interventional

Actual enrollment (reported)

Locations

1 country

Sites

Timeline

Study Start

October 31, 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 1, 2017

Actual (reported)

Study Completion

November 1, 2017

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 49 participants
Study completion date: November 1, 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 31, 2015
Actual (reported)
Study Start
October 31, 2015
Date type not reported
This date has not been verified as actual or estimated.
First Posted
November 3, 2015
Actual (reported)
Primary Completion
November 1, 2017
Actual (reported)
Study Completion
November 1, 2017
Actual (reported)

Last Updated: December 3, 2019
Status Verified: November 1, 2017
Last Update Submitted: November 30, 2019

Conditions

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

Keywords

Influenza AH3N2Challenge ModelInfluenzaHuman Challenge

Outcome Measures

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Greater than or equal to 18 and less than or equal to 50 years of age.
Agrees to not use tobacco products during participation in this study.
Willingness to remain in isolation for the duration of viral shedding (at a minimum 9 days) and to comply with all study requirements.
A female participant is eligible for this study if she is not pregnant or breastfeeding and meets 1 of the following criteria:
Of nonchildbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in more than or equal to 1 year).
Of childbearing potential but agrees to practice effective contraception or abstinence for 4 weeks prior to and 8 weeks after administration of the influenza challenge virus. Acceptable methods of contraception include 1 or more of the following: 1) male partner who is sterile prior to the female participant s entry into the study and is the sole sexual partner for the female participant; 2) implants of levonorgestrel; 3) injectable progestogen; 4) an intrauterine device with a documented failure rate of \<1%; 5) oral contraceptives; and 6) double barrier methods including diaphragm or condom with a spermicide.
Willing to have samples stored for future research.
Pre-challenge serum hemaglutination-inhibition titer against the challenge strain of less than 1:40.
HIV uninfected.

You may not qualify if:

Presence of self-reported or medically documented significant medical condition including but not limited to:
Chronic pulmonary disease (e.g., asthma, emphysema).
Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
Immunosuppression or ongoing malignancy.

Contact the study team to confirm eligibility.

Influenza A H3N2 Human Challenge Study in Healthy Adult Volunteers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations