Single Dose Texas 2017 (H3N2) Challenge Study (NCT06476275) | Clinical Trial Compass
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 range
18 Years – 46 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Number of participants with On-breath volatile markers that correlate with clinical symptoms
Timeframe: Baseline (Day -1) through Day 8
3
Number of participants with Biomarker expression changes that correlate with clinical symptoms
. 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
Exclusion criteria
2. Vital signs as follows:
3. Eligibility laboratory values (WBC, Absolute Lymphocyte Count, Hgb, PLTs, ALT and Cr) are within acceptable parameters
4. Body mass index (BMI) \>18.5 and \<40 kg/m2 at screening
5. Other screening tests (ECG and CXR) are within normal reference range or not deemed clinically significant by the PI or appropriate sub-investigator
6. Negative test for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) at screening
7. Negative multiplex respiratory virus panel on Day -2, and Day -1
8. Negative RT-PCR test for SARS-CoV-2 on screening and Day -2
9. HAI antibody titer ≤1:40 against influenza A/Texas/71/2017 (H3N2) at screening