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
Eligible age
18–50 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
You may not qualify if…
- ✕ A 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 within 6 months prior to enrollment.
- ✕ Plan to or are required to receive the 2025-2026 licensed influenza vaccine
- ✕ 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 · NCT06863142 · last updated 2026-07-21