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Virus Therapy

Influenza Virus Challenge for Flu

Phase 1
Recruiting
Led By Matthew J Memoli, M.D.
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
Female participants must meet specific criteria related to fertility, contraception, and HIV status
Age between 18 and 50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial is testing the smallest dose of influenza H10N7 virus that may cause an uncomplicated mild to moderate flu infection in healthy people.

Who is the study for?
Healthy adults aged 18-50 who can consent and agree to stay in isolation for at least 10 days without using tobacco, marijuana, or vaping. Women must meet specific fertility and HIV criteria; men must meet certain fertility conditions. Excludes those with significant medical issues, high-risk contacts, abnormal test results, recent illness or vaccinations, drug/alcohol abuse, psychiatric problems, non-English speakers.Check my eligibility
What is being tested?
The trial is testing the smallest dose of H10N7 flu virus that causes mild to moderate infection in healthy people. This will help evaluate new flu vaccines' effectiveness. Participants will receive one dose via nasal spray and be monitored closely with frequent tests and symptom surveys.See study design
What are the potential side effects?
Potential side effects may include typical flu symptoms such as fever, coughing, sore throat, aches but are expected to be mild to moderate given the controlled setting of the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman following specific fertility and contraception guidelines and do not have HIV.
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I am between 18 and 50 years old.
Select...
I am following the required guidelines for contraception and fertility.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The rate of MMID, defined as a positive FDA-approved clinical test for influenza plus one or more influenza symptoms, is induced.
Secondary outcome measures
Daily and total score on FLUPRO questionnaire and number and duration of symptoms and signs elicited by daily oral history and clinical exam

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
All participants receive challenge virus

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
3,265 Previous Clinical Trials
5,483,852 Total Patients Enrolled
Matthew J Memoli, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
14 Previous Clinical Trials
38,113 Total Patients Enrolled

Media Library

A/Mallard/Ohio-99/MM4/1989 H10N7 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05436444 — Phase 1
Flu Research Study Groups: 1
Flu Clinical Trial 2023: A/Mallard/Ohio-99/MM4/1989 H10N7 Highlights & Side Effects. Trial Name: NCT05436444 — Phase 1
A/Mallard/Ohio-99/MM4/1989 H10N7 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05436444 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the regulatory agency given its approval to A/Mallard/Ohio-99/MM4/1989 H10N7?

"We assessed the safety of A/Mallard/Ohio-99/MM4/1989 H10N7 to be a 1 as there is restricted evidence in terms of both efficacy and safety, seeing as this is an initial Phase 1 trial."

Answered by AI

How can I be considered for inclusion in this clinical experiment?

"This clinical trial seeks to enroll two hundred individuals of legal adulthood between 18 and 50 years old suffering from influenza. To be considered, candidates must adhere to the following conditions: have attained age eighteen or above (but below fifty) with no usage of tobacco products, marijuana, nor vaping; lack fertility in terms of a successful vasectomy or hysterectomy along with postmenopausal status; commit to maintaining abstinence and remain isolated for at least ten calendar days as well as comply with all study demands; consent to appropriate contraceptive methods such as implantable levonorgestrels or diaphragms when engaging in heterosexual intercourse alongside allowing"

Answered by AI

Is the upper age limit for inclusion in this trial above 35 years?

"According to the requirements of this medical trial, potential enrollees must be between 18 and 50 years old."

Answered by AI

Are there currently any open slots for potential participants in this trial?

"As indicated on clinicaltrials.gov, this medical trial is no longer recruiting patients for participation. Despite the initial posting taking place on December 7th 2022 and the most recent update being made on December 1st 2022, there are still 112 other trials that require volunteers at present."

Answered by AI
~117 spots leftby Oct 2024