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Virus Therapy
Dose, Safety, Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine, VRC-FLUNPF0103-00-VP, in Healthy Adults
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
No Placebo-Only Group
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 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
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 moreSecondary 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 • NCT0457925038%
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%
0%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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
3,327 Previous Clinical Trials
5,365,964 Total Patients Enrolled
Joseph P Casazza, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
2 Previous Clinical Trials
70 Total Patients Enrolled