Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vacc… (NCT06863142) | Clinical Trial Compass
RecruitingPhase 1
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
United States45 participantsStarted 2025-04-28
Plain-language summary
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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* A participant must meet all of the following criteria:
* Healthy adults between the ages of 18-50 years, inclusive
* Based on history and physical examination, be in good general health and without a history of any of the conditions listed in the exclusion criteria
* Received at least one licensed influenza vaccine from the 2020-2021 influenza season through the 2024-2025 influenza season
* Able and willing to complete the informed consent process
* Available for clinic visits for 68 weeks after enrollment, including through the 2025-2026 influenza season
* Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
* Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) \<= 35 within the 56 days before enrollment
* Agrees to not receive the 2025-2026 licensed influenza vaccination during study participation due to potential confounding of study results
* Willing to have blood and mucosal samples collected, stored indefinitely, and used for research purposes
* Laboratory Criteria within 56 days before enrollment
* White blood cells (WBC) and differential within institutional normal range or accompanied by approval of the site Principal Investigator (PI) or designee
* Total lymphocyte count \>= 800 cells/microL
* Platelets = 125,000 - 400,000 cells/microL
* Hemoglobin within institutional normal range or accompanied by…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of the FluMos-v2 (180 mcg) vaccine with ALFQ adjuvant administered to healthy adults at Day 0 and Week 16.
Timeframe: Through 68 weeks following the first vaccine administration, including through the 2025-2026 influenza season.
2
Safety and tolerability of the FluMos-v2 (60 mcg) vaccine with ALFQ adjuvant administered to healthy adults at Day 0 and Week 16.
Timeframe: Through 68 weeks following the first vaccine administration, including through the 2025-2026 influenza season.
3
Safety and tolerability of the FluMos-v2 (180 mcg) vaccine administered alone to healthy adults at Day 0 and Week 16.
Timeframe: Through 68 weeks following the first vaccine administration, including through the 2025-2026 influenza season
Trial details
NCT IDNCT06863142
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)