← Back to Search

Virus Therapy

Influenza RG-A/Texas/71/2017 (H3N2) Challenge for Influenza

Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -1 (baseline), day 8, day 15, and day 29
Awards & highlights

Summary

This trial uses a specially made flu virus to find the safest dose that still makes people sick. Healthy adults are chosen because they are less likely to have other health issues. Researchers give different doses of the virus and watch how the body responds to find the best amount for future studies.

Eligible Conditions
  • Influenza

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -1 (baseline), day 8, day 15, and day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -1 (baseline), day 8, day 15, and day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Duration of Viral Shedding
Mean Maximum Cumulative Modified Jackson Score (MJS)
Mean Peak Viral Load (VL) After Challenge
+3 more
Secondary study objectives
Geometric Mean HA-stalk-specific Antibody Titers Against A/Texas/71/2017 (H3N2), Clade 3C3a Virus, by Study Day
Geometric Mean Hemagglutination Inhibition (HAI) Antibody Titers Against A/Texas/71/2017 (H3N2), Clade 3C3a Virus, by Study Day
Geometric Mean Microneutralization (MN) Antibody Titers Against A/Texas/71/2017 (H3N2), Clade 3C3a Virus, by Study Day
+7 more

Side effects data

From 2022 Phase 1 trial • 60 Patients • NCT04978454
17%
Respiratory rate decreased
8%
Heart rate decreased
8%
Blood pressure diastolic decreased
8%
Vessel puncture site haematoma
8%
Arthropod bite
8%
Skin laceration
8%
Epistaxis
8%
Blood pressure diastolic increased
8%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
10^4 TCID50 Challenge Virus
10^5 TCID50 Challenge Virus
10^6 TCID50 Challenge Virus
Sham Inoculum

Trial Design

8Treatment groups
Experimental Treatment
Group I: Cohort 3BExperimental Treatment2 Interventions
10\^6 TCID50 of recombinant H3N2 (A/Texas/71/2017, clade 3C3a) 1.0 mL (0.5 mL per nostril) influenza virus (n=17) and Sham Sucrose phosphate glutamate (SPG) inoculum 1.0 mL (0.5 mL per nostril) (n=1) administered intranasally on Day 1. N = 18
Group II: Cohort 3AExperimental Treatment2 Interventions
10\^6 TCID50 of recombinant H3N2 (A/Texas/71/2017, clade 3C3a) 1.0 mL (0.5 mL per nostril) influenza virus (n=17) and Sham Sucrose phosphate glutamate (SPG) inoculum 1.0 mL (0.5 mL per nostril) (n=1) administered intranasally on Day 1. If no safety threshold is met (halting conditions) proceed to Cohort 3B. N = 18
Group III: Cohort 2CExperimental Treatment2 Interventions
10\^5 TCID50 of recombinant H3N2 (A/Texas/71/2017, clade 3C3a) 1.0 mL (0.5 mL per nostril) influenza virus (n=12) and Sham Sucrose phosphate glutamate (SPG) inoculum 1.0 mL (0.5 mL per nostril) (n=1) administered intranasally on Day 1. If 70% or more of the subjects in Cohorts 2A, 2B, and 2C combined meet the case definition for influenza then the optimal dose of 10\^4 TCID50 will be selected. Cumulatively, if fewer than 70% of subjects in Cohorts 2A, 2B, and 2C meet the case definition for influenza the dose will escalate to include Cohort 3A. N = 13
Group IV: Cohort 2BExperimental Treatment2 Interventions
10\^5 TCID50 of recombinant H3N2 (A/Texas/71/2017, clade 3C3a) 1.0 mL (0.5 mL per nostril) influenza virus (n=12) and Sham Sucrose phosphate glutamate (SPG) inoculum 1.0 mL (0.5 mL per nostril) (n=1) administered intranasally on Day 1.If 70% or more subjects in Cohort 2A and 2B meet the case definition for influenza, proceed to Cohort 2C. Cumulatively, if fewer than 70% of subjects in Cohorts 2A and 2B meet the case definition for influenza, the dose will escalate to include Cohort 3A N = 13
Group V: Cohort 2AExperimental Treatment2 Interventions
10\^5 TCID50 of recombinant H3N2 (A/Texas/71/2017, clade 3C3a) 1.0 mL (0.5 mL per nostril) influenza virus (n=12) and Sham Sucrose phosphate glutamate (SPG) inoculum 1.0 mL (0.5 mL per nostril) (n=1) administered intranasally on Day 1. If 70% or more subjects in Cohort 2A meet the case definition for influenza, proceed to Cohort 1B. If fewer than 70% of subjects meet the case definition for influenza in Cohort 2A, the dose will escalate to include Cohort 3A. N = 13
Group VI: Cohort 1CExperimental Treatment2 Interventions
10\^4 TCID50 of recombinant H3N2 (A/Texas/71/2017, clade 3C3a) 1.0 mL (0.5 mL per nostril) influenza virus (n=12) and sham sucrose phosphate glutamate (SPG) inoculum 1.0 mL (0.5 mL per nostril) (n=1) administered intranasally on Day 1. If 80% or more of the subjects in Cohorts 1A, 1B, and 1C combined meet the case definition for influenza then the optimal dose of 104 TCID50 will be selected. Cumulatively, if fewer than 80% of subjects in Cohorts 1A, 1B, and 1C meet the case definition for influenza the dose will escalate to include Cohort 2A. N = 13
Group VII: Cohort 1BExperimental Treatment2 Interventions
10\^4 TCID50 of recombinant H3N2 (A/Texas/71/2017, clade 3C3a) 1.0 mL (0.5 mL per nostril) influenza virus (n=12) and Sham Sucrose phosphate glutamate (SPG) inoculum 1.0 mL (0.5 mL per nostril) (n=1) administered intranasally on Day 1. If 80% or more subjects in Cohort 1A and 1B meet the case definition for influenza, proceed to Cohort 1C. Cumulatively, if fewer than 80% of subjects in Cohorts 1A and 1B meet the case definition for influenza, the dose will escalate to include Cohort 2A. N = 13
Group VIII: Cohort 1AExperimental Treatment2 Interventions
10\^4 TCID50of recombinant H3N2 (A/Texas/71/2017, clade 3C3a) 1.0 mL (0.5mL per nostril) influenza virus (n=12) and Sham Sucrose phosphate glutamate (SPG) inoculum 1.0 mL (0.5mL per nostril) (n=1) administered intranasally on Day 1. If 80% or more subjects in Cohort 1A meet the case definition for influenza, proceed to Cohort 1B. If fewer than 80% of subjects meet the case definition for influenza in Cohort 1A, the dose will escalate to include Cohort 2A. N = 13
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza RG-A/Texas/71/2017 (H3N2) Challenge
2021
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,302 Previous Clinical Trials
5,501,382 Total Patients Enrolled
~15 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top