Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (SteMos1) With and Without ALFQ Adjuvant in Healthy Adults
Eligible age
18–50 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
You may not qualify if…
- ✕ Participant will be excluded if one or more of the following conditions apply:
- ✕ Women who are breast-feeding or planning to become pregnant during the study
- ✕ A participant has received any of the following substances:
- ✕ Receipt of any licensed influenza vaccine or lab-confirmed influenza infection within 6 months prior to enrollment.
- ✕ Plan to or are required to receive the 2025-2026 or 2026-2027 licensed influenza vaccines
- ✕ Live attenuated vaccines within 4 weeks prior to enrollment
- ✕ Inactivated vaccines within 2 weeks prior to enrollment
- ✕ mRNA vaccines within 4 weeks prior to enrollment
Where it's recruiting
Bethesda
Source: ClinicalTrials.gov · NCT07111078 · last updated 2026-06-04