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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

Summary

This trial tests a new flu vaccine (H10ssF-6473) in healthy adults aged 18-70. The vaccine aims to help the body fight a specific flu strain by teaching the immune system to recognize it. Participants received one or two shots and were monitored for safety and immune response over time.

Eligible Conditions
  • Influenza

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
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
36%
Administration site pain
36%
Malaise
29%
Anaemia
21%
Myalgia
14%
Chills
14%
Bradycardia
14%
Aspartate aminotransferase increased
7%
Neutropenia
7%
Leukopenia
7%
Dizziness
7%
Lymphopenia
7%
Citrate toxicity
7%
Headache
7%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 2A: H10ssF-6473 (60 mcg), Ages 18-50 Years
Group 2B: H10ssF-6473 (60 mcg), Ages 55-70 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

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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
3,302 Previous Clinical Trials
5,501,417 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
~5 spots leftby Sep 2025
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