Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476275
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-21
Brief Title:
Single Dose Texas 2017 H3N2 Challenge Study
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Blinded Randomized Placebo-Controlled Influenza Challenge Study in Healthy Adult Volunteers Using a Recombinant H3N2 ATexas712017 H3N2 Clade 3C3a Influenza Challenge Virus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall objective of the present study is to utilize the recombinant H3N2 ATexas712017 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 140 against the challenge strain Each participant will complete up to 3 weeks of follow-up post confinement
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 140 against the challenge strain Each participant will complete up to 3 weeks of follow-up post confinement
Detailed Description:
Human influenza virus challenge models are used to understand the host molecular and physiologic response to common respiratory viruses the natural history of disease and the immune response in a controlled environment These studies allow for better understanding of the human-virus interaction and can contribute to efforts to develop improved vaccines treatments and diagnostics that may limit the spread of disease The overall objective of this study is to utilize the recombinant H3N2 ATexas712017 H3N2 clade 3C3a influenza virus for a controlled human infection model to study host responses to influenza virus with the aim of identifying digital markers expressed biomarkers in saliva and volatile markers in exhaled breath for early detection of infection after pathogen exposure
The goal of this study is to characterize host responses to influenza virus with the aim of identifying digital biomarkers expression markers in saliva and volatile markers in exhaled breath for early detection of infection after pathogen exposure but prior to development of symptoms Healthy volunteers will be either sham-inoculated or inoculated with influenza H3N2 ATexas712017 H3N2 clade 3C3a virus at 106 TCID50 concentration which is known to elicit a 60-80 attack rate The host response to influenza challenge will be described by a variety of clinical endpoints measured longitudinally in the challenge group over the post-challenge period
Eligible study participants will complete informed consent and a screening evaluation around 6 weeks prior to the challenge study Participants will be admitted to the inpatient unit 2 days prior to inoculation and will remain until approximately Day 8-10 post challenge Each participant will be followed for an additional 3 weeks of post confinement
On Day 1 participants will be randomized and administered a single challenge dose of either a sham inoculum or a virus dose at 10e6 TCID50 The challenge inoculum will be administered using an Intranasal Mucosal Atomization Device attached to a 1cc syringe Approximately 500 μL of study product will be delivered in each nostril with the participant in a recumbent position Participants clinical study staff administrators of challenge inoculum and clinical evaluators will be blinded as to whether the participant received either sham or virus challenge inoculum Participants receiving sham dosing will be chosen randomly
During the confinement period pre-challenge to Day 8 time-series collections of biological samples blood saliva breath and clinical information will occur at least daily Exhaled breath will be captured using a breath sampling system developed by Owlstone Ltd for the consistent collection of human breath samples and concentration of volatile organic compounds During breath collection a single-use mouthpiece is attached to a Breath Sampler collection device and held in the participants mouth while wearing a nose clip The Breath Sampler concentrates exhaled breath onto sorbent tubes prior to analysis by thermal desorption-gas chromatography mass spectrometry where volatile metabolites are identified and quantified
Additionally participants will be provided wearable devices for continuous monitoring of physiological measures including heart rate heart rhythm monitor body temperature and sleep habits Each subject will also be asked to sign a separate repository consent to allow for retention of samples for future use
The goal of this study is to characterize host responses to influenza virus with the aim of identifying digital biomarkers expression markers in saliva and volatile markers in exhaled breath for early detection of infection after pathogen exposure but prior to development of symptoms Healthy volunteers will be either sham-inoculated or inoculated with influenza H3N2 ATexas712017 H3N2 clade 3C3a virus at 106 TCID50 concentration which is known to elicit a 60-80 attack rate The host response to influenza challenge will be described by a variety of clinical endpoints measured longitudinally in the challenge group over the post-challenge period
Eligible study participants will complete informed consent and a screening evaluation around 6 weeks prior to the challenge study Participants will be admitted to the inpatient unit 2 days prior to inoculation and will remain until approximately Day 8-10 post challenge Each participant will be followed for an additional 3 weeks of post confinement
On Day 1 participants will be randomized and administered a single challenge dose of either a sham inoculum or a virus dose at 10e6 TCID50 The challenge inoculum will be administered using an Intranasal Mucosal Atomization Device attached to a 1cc syringe Approximately 500 μL of study product will be delivered in each nostril with the participant in a recumbent position Participants clinical study staff administrators of challenge inoculum and clinical evaluators will be blinded as to whether the participant received either sham or virus challenge inoculum Participants receiving sham dosing will be chosen randomly
During the confinement period pre-challenge to Day 8 time-series collections of biological samples blood saliva breath and clinical information will occur at least daily Exhaled breath will be captured using a breath sampling system developed by Owlstone Ltd for the consistent collection of human breath samples and concentration of volatile organic compounds During breath collection a single-use mouthpiece is attached to a Breath Sampler collection device and held in the participants mouth while wearing a nose clip The Breath Sampler concentrates exhaled breath onto sorbent tubes prior to analysis by thermal desorption-gas chromatography mass spectrometry where volatile metabolites are identified and quantified
Additionally participants will be provided wearable devices for continuous monitoring of physiological measures including heart rate heart rhythm monitor body temperature and sleep habits Each subject will also be asked to sign a separate repository consent to allow for retention of samples for future use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None