CompletedPhase 1

Single Dose Texas 2017 (H3N2) Challenge Study

United States33 participantsStarted 2024-09-11

Plain-language summary

The overall objective of the present study is to utilize the recombinant H3N2 (A/Texas/71/2017 (H3N2, clade 3C3a)) influenza virus for a controlled human infection model to study host responses to influenza virus with the aim of identifying volatile markers in exhaled breath and expression markers in saliva for early detection of infection after pathogen exposure. This study will aim to recruit up to 40 healthy volunteers between ages 18-45 who will receive a single dose of either intranasally administered placebo (sham inoculum) or the virus challenge strain at a concentration known to elicit a \~60-80% attack rate. The response to influenza challenge will be measured by clinical, laboratory, immunological, digital biomarker, on-breath volatile organic compound data and host RNA expression in both blood and saliva. The study will enroll and challenge up to 34 healthy adult volunteers with live virus plus approximately 6 sham-inoculated controls who will be prescreened for study inclusion to have serological antibody titers of ≤1:40 against the challenge strain. Each participant will complete up to 3 weeks of follow-up post confinement.

Who can participate

Age range18 Years – 46 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provide written informed consent prior to initiation of any study procedure
✓. Are able to understand and comply with planned study procedures and be available for all study visits
✓. Agree to remain an inpatient for at least 7 days after challenge AND until they have no viral shedding, determined by qualitative RT-PCR beginning on Study Day 6
✓. Healthy males and non-pregnant, non-breastfeeding females aged ≥ 18 and \< 46 years of age at enrollment NOTE: Female subjects of childbearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test upon admission to the confinement unit AND a negative pregnancy test before any CXR (if ≥ 7 days have passed since a serum pregnancy test).
✓. Women of childbearing potential must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception for at least 30 days prior to challenge
✓. Non-habitual smoker of tobacco, e-cigarettes or marijuana
✓. No self-reported or known history of alcoholism within the last 2 years and agrees to abstain from alcohol for at least one week before admission and throughout the confinement period
✓. No self-reported or known history of restricted drug use for at least 30 days prior to challenge and agrees to abstain from restricted drugs throughout the confinement period

What they're measuring

Number of participants with detectable viral shedding in nasopharyngeal (NP) swab(s) by qualitative RT-PCR over any 2 days and with symptomatic infection

Timeframe: 24 hours post challenge through Day 8

Number of participants with On-breath volatile markers that correlate with clinical symptoms

Timeframe: Baseline (Day -1) through Day 8

Number of participants with Biomarker expression changes that correlate with clinical symptoms

Timeframe: Baseline (Day -1) through Day 8

Trial details

NCT IDNCT06476275

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-15

View on ClinicalTrials.gov More Influenza Viral Infections trials

Plain-language summary

Who can participate

Age range18 Years – 46 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provide written informed consent prior to initiation of any study procedure
✓. Are able to understand and comply with planned study procedures and be available for all study visits
✓. Agree to remain an inpatient for at least 7 days after challenge AND until they have no viral shedding, determined by qualitative RT-PCR beginning on Study Day 6
✓. Healthy males and non-pregnant, non-breastfeeding females aged ≥ 18 and \< 46 years of age at enrollment NOTE: Female subjects of childbearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test upon admission to the confinement unit AND a negative pregnancy test before any CXR (if ≥ 7 days have passed since a serum pregnancy test).
✓. Women of childbearing potential must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception for at least 30 days prior to challenge
✓. Non-habitual smoker of tobacco, e-cigarettes or marijuana
✓. No self-reported or known history of alcoholism within the last 2 years and agrees to abstain from alcohol for at least one week before admission and throughout the confinement period
✓. No self-reported or known history of restricted drug use for at least 30 days prior to challenge and agrees to abstain from restricted drugs throughout the confinement period

What they're measuring

Number of participants with detectable viral shedding in nasopharyngeal (NP) swab(s) by qualitative RT-PCR over any 2 days and with symptomatic infection

Timeframe: 24 hours post challenge through Day 8

Number of participants with On-breath volatile markers that correlate with clinical symptoms

Timeframe: Baseline (Day -1) through Day 8

Number of participants with Biomarker expression changes that correlate with clinical symptoms

Timeframe: Baseline (Day -1) through Day 8

Single Dose Texas 2017 (H3N2) Challenge Study

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Single Dose Texas 2017 (H3N2) Challenge Study

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria