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

Recruiting now · Phase 1

Conditions studied: Influenza Prevention, Pandemic Influenza Prevention

In brief

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 facts

Study ID

NCT07111078

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

56

Starts

2025-08-27

Expected to finish

2027-08-18

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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
• Receipt of the HA ferritin influenza vaccine VRC-FLUNPF081-00-VP alone or in prime-boost regimens with VRC-FLUDNA082-00-VP (HA-F A/Sing, DNA A/Sing, VRC 316).
• Receipt of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-v1, VRC 325)
• Receipt of the mosaic hexavalent influenza vaccine VRC-FLUMOS0116-00-VP (FluMos-v2, VRC 326)
• More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
• Blood products within 16 weeks prior to enrollment
• Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
• Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
• Current anti-TB prophylaxis or therapy
• Participant has a history of any of the following clinically significant conditions:
• Serious reactions to vaccines that preclude receipt of the study vaccinations as determined by the PI or designee
• Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
• Asthma that is not well controlled
• Diabetes mellitus (type I or II), except for gestational diabetes
• Thyroid disease that is not well controlled
• Idiopathic urticaria within the past year
• Immune-mediated diseases, such as autoimmune or autoinflammatory diseases, or immunodeficiencies
• Hypertension that is not well controlled

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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