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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -1 (baseline), day 8, day 15, and day 29

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

Heart rate decreased

Blood pressure diastolic decreased

Vessel puncture site haematoma

Arthropod bite

Skin laceration

Epistaxis

Blood pressure diastolic increased

Hypertension

100%

80%

60%

40%

20%

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

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

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