Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (SteMos1) With and Without ALFQ Adjuvant in Healthy Adults

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07111078
Phase
PHASE1
Status
Recruiting
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Conditions

  • Influenza Prevention
  • Pandemic Influenza Prevention

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • VRC-FLUMOS0122-00-VP — BIOLOGICAL
    The VRC-FLUMOS0122-00-VP (SteMos1) is composed of de novo engineered pentamer assembled with de novo engineered trimeric domains to an icosahedral core, projecting 20 HA stabilized stem trimers from four influenza A strains representing both Group 1 (H2, H5) and Group 2 (H7, H10) viruses.
  • ALFQ — OTHER
    The ALFQ drug product is a sterile suspension that contains 240 mcg of monophosphoryl 3-deacyl Lipid A (3D-PHAD) and 120 mcg QS-21

Study Details

Background: Influenza (flu) is a contagious respiratory illness caused by viruses. Flu symptoms can range from mild to severe, and the illness can be fatal. Vaccines help the body learn to prevent or fight infections such as flu. Some vaccines are combined with adjuvants. Adjuvants are special salts or fats that help vaccines work better. Researchers are looking for ways to make flu vaccines more effective. Objective: To test a new flu vaccine with and without a new adjuvant. Eligibility: Healthy adults aged 18 to 50. They must have had at least 1 flu vaccine since 2020. Design: Participants will have 12 clinic visits over 15 months. The vaccine is given as an injection into the muscle of the upper arm. Participants will be vaccinated during 2 visits spaced 4 months apart. Half will receive just the vaccine; half will receive the vaccine plus the adjuvant. They will be monitored for at least 30 minutes after each shot. Participants will keep a diary for 7 days after each shot. They check their temperature every day and record any symptoms. Participants will have 10 follow-up clinic visits plus 4 phone calls. They will have 4 to 10 tablespoons of blood drawn at each clinic visit. Fluid samples will be collected from their nose and mouth. They will be checked for any health changes. Participants may opt to undergo apheresis: Blood will be taken from the body through a needle inserted into a vein. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a different needle.

Key Dates

Start date
Aug 27, 2025
Status verified
Jun 2026
Primary completion
Aug 18, 2027
Completion
Aug 18, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1
    60 mcg of SteMos1 on Day 0 and Week 16
  • Experimental: Group 2
    180 mcg of SteMos1 on Day 0 and Week 16
  • Experimental: Group 3
    60 mcg of SteMos1 + 0.5 ml of ALFQ on Day 0 and Week 16
  • Experimental: Group 4
    180 mcg of SteMos1 + 0.5 ml of ALFQ on Day 0 and Week 16
  • Experimental: Group 5- optional
    SteMos1 \[dose TBD based on interim analysis of data from Groups 3-4\] + 0.5 ml of ALFQ on Day 0 and Week 16

Primary Outcome Measure

Safety and tolerability of 180 mg VRCFLUMOS0122-00-VP (SteMos1) vaccine with ALFQ adjuvant administered as a 2-dose regimen [ Time Frame: Though 52 weeks after the second vaccine administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
VRC Clinic
[email protected]
301-451-8715

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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