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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

VRC 328: A Phase I Open-Label Clinical Trial to Evaluate the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults

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 (NCT06863142) is a Phase 1 interventional studying Influenza Prevention and Seasonal Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Influenza Prevention, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 45 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

* Who May Qualify: - 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 willing to sign a consent form 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 approval of the PI or designee - Alanine aminotransferase (ALT) \<= 1.25 x institutional upper limit of normal (ULN) - Aspartate aminotransferase (AST) \<= 1.25 x institutional ULN - Alkaline phosphatase (ALP) \< 1.1 x institutional ULN - Total bilirubin within institutional normal range or accompanied by approval of the PI or designee - Serum creatinine \<= 1.1 x institutional ULN - Negative for HIV infection by an FDA-approved method of detection - Criteria applicable to women of childbearing potential: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
* 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 approval of the PI or designee * Alanine aminotransferase (ALT) \<= 1.25 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) \<= 1.25 x institutional ULN * Alkaline phosphatase (ALP) \< 1.1 x institutional ULN * Total bilirubin within institutional normal range or accompanied by approval of the PI or designee * Serum creatinine \<= 1.1 x institutional ULN * Negative for HIV infection by an FDA-approved method of detection * Criteria applicable to women of childbearing potential: * Negative beta-human chorionic gonadotropin (Beta-HCG) pregnancy test (urine or serum) on the day of enrollment * Agrees to use an effective method of birth control from at least 21 days prior to enrollment through the end of the study. EXCLUSION CRITERIA: * 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 * Receipt of 20 mcg of the influenza vaccine VRC-FLUNPF081-00-VP (HA-F A/Sing, VRC 316, Group 1) * 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 * Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws * Malignancy that is active or history of malignancy that is likely to recur during the period of the study * Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years * Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen * Guillain-Barre Syndrome * Any medical, social condition, occupational reason, or other reason that, in the judgment of the PI or designee, is a contraindication to protocol participation or impairs a participant s ability to give informed consent, including but not limited to clinically significant forms of infectious diseases, drug or alcohol abuse, autoimmune diseases, psychiatric disorders, or heart disease.

Treatments Being Tested

BIOLOGICAL

VRC-FLUMOS0116-00-VP

The VRC-FLUMOS0116-00-VP (FluMos-v2) vaccine is composed of de novo engineered pentamer assembled with de novo engineered trimeric domains to an icosahedral core, projecting 20 HA ectodomain trimers from influenza strains: Influenza A (H1-H3) and Influenza B (Victoria lineage and Yamagata lineage)

OTHER

ALFQ

The ALFQ adjuvant is a sterile suspension that contains monophosphoryl 3-deacyl Lipid A \[3D-PHAD(R)\] and QS-21

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Institutes of Health Clinical Center
Bethesda, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06863142), the sponsor (National Institute of Allergy and Infectious Diseases (NIAID)), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06863142 clinical trial studying?

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 vis… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06863142?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06863142?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06863142. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06863142. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.