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Virus Therapy

Group 1: H10ssF-6473 (20 mcg), ages 18-50 years for Influenza

Phase 1

Waitlist Available

Led By Joseph P Casazza, 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days after each h10ssf-6473 product administration, at approximately week 1 and at approximately week 17

Awards & highlights

Study Summary

This trial is testing a potential vaccine for influenza, to see if it is safe and effective. Eligible participants must be healthy adults aged 18-70, and the trial will last for around 10 months.

Eligible Conditions

Influenza

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days after each h10ssf-6473 product administration, at approximately week 1 and at approximately week 17

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days after each h10ssf-6473 product administration, at approximately week 1 and at approximately week 17

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after each h10ssf-6473 product administration, at approximately week 1 and at approximately week 17 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H10ssF-6473 Product Administration

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H10ssF-6473 Product Administration

Number of Participants With Abnormal Laboratory Measures of Safety Following H10ssF-6473 Product Administration

+4 more

Secondary outcome measures

Stem-Specific Antibody Response to H10ssF-6473 Following the Completion of Each Vaccination Regimen

Side effects data

From 2022 Phase 1 trial • 25 Patients • NCT04579250

38%

Administration site pain

25%

Headache

13%

Paronychia

13%

Viral infection

13%

Hypercholesterolaemia

13%

Contusion

13%

Muscle strain

13%

Hypertension

13%

Administration site swelling

13%

Myalgia

13%

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Group 2B: H10ssF-6473 (60 mcg), Ages 55-70 Years

Group 2A: H10ssF-6473 (60 mcg), Ages 18-50 Years

Overall Group 2: H10ssF-6473 (60 mcg)

Group 1: H10ssF-6473 (20 mcg), Ages 18-50 Years

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 2B: H10ssF-6473 (60 mcg), ages 55-70 yearsExperimental Treatment1 Intervention

H10ssF-6473 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)

Group II: Group 2A: H10ssF-6473 (60 mcg), ages 18-50 yearsExperimental Treatment1 Intervention

H10ssF-6473 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)

Group III: Group 1: H10ssF-6473 (20 mcg), ages 18-50 yearsExperimental Treatment1 Intervention

H10ssF-6473 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VRC-FLUNPF0103-00-VP (H10ssF-6473)

2020

Completed Phase 1

~30

Do I qualify?Apply below to find out

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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

3,269 Previous Clinical Trials

5,481,444 Total Patients Enrolled

Joseph P Casazza, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

1 Previous Clinical Trials

10 Total Patients Enrolled

Frequently Asked Questions

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

What potential hazards are posed by the drug VRC-FLUNPF0103-00-VP (H10ssF-6473) to individuals?

"Given its status as a Phase 1 trial, and thus lack of evidence for both safety and efficacy, the VRC-FLUNPF0103-00-VP (H10ssF-6473) was assigned a score of 1."

Answered by AI

What are the requirements for enrolling in this clinical trial?

"The clinical trial seeks 25 adults between the ages of 18-70 (with exceptions for those born 1965-1970) with influenza induced flu. The ideal participants would be described as generally healthy and free from any conditions outlined in the study protocols."

Answered by AI

Does the trial accept participants below 50 years of age?

"According to the inclusion criteria, those aged 18-70 are eligible for this trial. There are additional 43 trials specifically designed for minors and 78 studies tailored towards older adults over 65 years of age."

Answered by AI

Are there any vacancies within this research trial?

"The details on clinicaltrials.gov reveal that this medical study is not actively recruiting any more participants, with the original posting taking place on October 8th 2020 and the last edit made to it occurring on March 9th 2022. Fortunately, there are 124 other trials in need of volunteers at the present time."

Answered by AI