Actively Recruiting
Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (SteMos1) With and Without ALFQ Adjuvant in Healthy Adults
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-27
56
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (SteMos1) With and Without ALFQ Adjuvant in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults between 18 and 50 years old, inclusive
- Received at least one licensed influenza vaccine between the 2020-2021 and 2024-2025 seasons
- In good general health without exclusion conditions based on history and physical exam
- Able and willing to complete informed consent
- Able to read and understand English
- Available for clinic visits for 68 weeks after first dose, including through the 2025-2026 flu season
- Able to provide proof of identity
- Physical exam and lab results without significant findings and BMI \u2264 35 within 56 days before enrollment
- Agrees not to receive any licensed flu vaccination during study participation
- Willing to have blood and mucosal samples collected, stored indefinitely, and used for research
- Laboratory values within normal ranges or approved by Principal Investigator within 56 days before enrollment
- Negative for HIV infection
- Women of childbearing potential must have a negative pregnancy test on enrollment day
- Women of childbearing potential agree to use effective birth control from 21 days before enrollment through study end
You will not qualify if you...
- Women who are breastfeeding or planning pregnancy during the study
- Received any licensed flu vaccine or lab-confirmed flu infection within 6 months before enrollment
- Plan to receive 2025-2026 or 2026-2027 licensed flu vaccines
- Received live attenuated vaccines within 4 weeks before enrollment
- Received inactivated vaccines within 2 weeks before enrollment
- Received mRNA vaccines within 4 weeks before enrollment
- Received specific investigational influenza vaccines (VRC-FLUNPF081-00-VP, VRC-FLUMOS0111-00-VP, VRC-FLUMOS0116-00-VP)
- More than 10 days of systemic immunosuppressive or cytotoxic medications within 4 weeks before enrollment or any within 14 days before enrollment
- Blood products within 16 weeks before enrollment
- Use of investigational research agents within 4 weeks before enrollment or planned during study
- Current allergy treatment with antigen injections unless on maintenance schedule
- Current anti-tuberculosis therapy or prophylaxis
- History of serious vaccine reactions preventing study vaccination
- History of hereditary, acquired, or idiopathic angioedema
- Poorly controlled asthma
- Diabetes mellitus (except gestational diabetes)
- Poorly controlled thyroid disease
- Idiopathic urticaria within past year
- Immune-mediated diseases or immunodeficiencies
- Poorly controlled hypertension
- Diagnosed bleeding disorders or significant bruising with injections or blood draws
- Active malignancy or malignancy likely to recur during study
- Seizure disorders except specific exceptions
- Asplenia or functional asplenia
- Guillain-Barré Syndrome
- Any other condition that impairs ability to consent or participate as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
V
VRC Clinic
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
5
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