Actively Recruiting
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-02-23
45
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Vaccines help the body learn to fight infections. Some vaccines are combined with adjuvants, which are added substances that make vaccines work better. FluMos-v2 is an experimental flu vaccine; ALFQ is an experimental adjuvant. Objective: To test FluMos-v2, with and without the ALFQ adjuvant, in healthy adults. Eligibility: Healthy adults aged 18 to 50 years. They must have received at least one flu vaccine from the 2020-21 season through the 2024-25 flu season. They must also agree not to receive the licensed 2025-26 flu vaccine. Design: Participants will have 12 clinic visits over 15 months. Participants will be screened. They will have a physical exam and blood tests. On 2 visits, about 4 months apart, participants will receive a vaccination. The shots will be given into the muscle of the upper arm. They will get a follow-up call the day after each shot. They will keep a daily diary for 7 days; they will record their temperature and any other symptoms they feel after each shot. All clinic visits will include collection of blood, saliva, and nasal secretions. If participants develop flu symptoms (such as fever, runny nose, sore throat), they will be asked to come to the clinic. About 2 weeks after each vaccination, participants may opt to undergo apheresis: Blood will be taken from the body through a needle inserted into one arm. 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 needle in the other arm.
CONDITIONS
Official Title
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 50 years inclusive
- Received at least one licensed influenza vaccine from 2020-2021 through 2024-2025 seasons
- Good general health based on history and physical exam
- Able and willing to complete informed consent
- Available for clinic visits for 68 weeks including through the 2025-2026 influenza season
- Able to provide proof of identity to study staff
- Physical exam and labs without significant findings and Body Mass Index (BMI) of 35 or less within 56 days before enrollment
- Agree not to receive the licensed 2025-2026 influenza vaccine during study participation
- Willing to provide blood and mucosal samples for research
- Laboratory values within defined normal ranges or with PI approval
- 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 influenza vaccine within 6 months prior to enrollment
- Plan to receive the 2025-2026 licensed influenza vaccine
- Received live attenuated vaccines within 4 weeks prior to enrollment
- Received inactivated vaccines within 2 weeks prior to enrollment
- Received mRNA vaccines within 4 weeks prior to enrollment
- Received specific influenza vaccines (VRC-FLUNPF081-00-VP, FluMos-v1, FluMos-v2) prior to enrollment
- Used systemic immunosuppressive or cytotoxic medications over 10 days within 4 weeks prior to enrollment or any within 14 days prior
- Received blood products within 16 weeks prior to enrollment
- Used investigational agents within 4 weeks prior or planning to during study
- Current allergy immunotherapy injections unless on maintenance
- Current anti-TB treatment
- History of serious vaccine reactions preventing study vaccines
- History of hereditary, acquired, or idiopathic angioedema
- Uncontrolled asthma
- Diabetes mellitus (type I or II) except gestational diabetes
- Uncontrolled thyroid disease
- Idiopathic urticaria within past year
- Immune-mediated or immunodeficiency diseases
- Uncontrolled hypertension
- Bleeding disorders or difficulties with injections or blood draws
- Active or likely recurrent malignancy
- Seizure disorders except specified exceptions
- Absence or removal of the spleen
- Guillain-Barre Syndrome
- Any condition judged by the investigator as a contraindication to participation or informed consent ability
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
4
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