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

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Conditions

Influenza PreventionSeasonal InfluenzaDose - EscalationImmune ResponseViral InfectionRespiratory IllnessExperimental VaccineExperimental AdjuvantInfluenza Vaccine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 2023-24 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.

Official Title

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

Quick Facts

Study Start:2025-04-28
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06863142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * A participant must meet all of the following criteria:
  2. * Healthy adults between the ages of 18-50 years, inclusive
  3. * 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
  4. * Received at least one licensed influenza vaccine from the 2020-2021 influenza season through the 2023-2024 influenza season
  5. * Able and willing to complete the informed consent process
  6. * Available for clinic visits for 68 weeks after enrollment, including through the 2025-2026 influenza season
  7. * Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
  8. * Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) \<= 35 within the 56 days before enrollment
  9. * Agrees to not receive the 2025-2026 licensed influenza vaccination during study participation due to potential confounding of study results
  10. * Willing to have blood and mucosal samples collected, stored indefinitely, and used for research purposes
  11. * Laboratory Criteria within 56 days before enrollment
  12. * White blood cells (WBC) and differential within institutional normal range or accompanied by approval of the site Principal Investigator (PI) or designee
  13. * Total lymphocyte count \>= 800 cells/microL
  14. * Platelets = 125,000 - 400,000 cells/microL
  15. * Hemoglobin within institutional normal range or accompanied by approval of the PI or designee
  16. * Alanine aminotransferase (ALT) \<= 1.25 x institutional upper limit of normal (ULN)
  17. * Aspartate aminotransferase (AST) \<= 1.25 x institutional ULN
  18. * Alkaline phosphatase (ALP) \< 1.1 x institutional ULN
  19. * Total bilirubin within institutional normal range or accompanied by approval of the PI or designee
  20. * Serum creatinine \<= 1.1 x institutional ULN
  21. * Negative for HIV infection by an FDA-approved method of detection
  22. * Criteria applicable to women of childbearing potential:
  23. * Negative beta-human chorionic gonadotropin (Beta-HCG) pregnancy test (urine or serum) on the day of enrollment
  24. * Agrees to use an effective method of birth control from at least 21 days prior to enrollment through the end of the study.
  1. * A participant will be excluded if one or more of the following conditions apply:
  2. * A Participant has received any of the following substances:
  3. * Receipt of any licensed influenza vaccine within 6 months prior to enrollment.
  4. * Plan to or are required to receive the 2025-2026 or received the 2024-2025 licensed influenza vaccines
  5. * Live attenuated vaccines within 4 weeks prior to enrollment
  6. * Inactivated vaccines within 2 weeks prior to enrollment
  7. * mRNA vaccines within 4 weeks prior to enrollment
  8. * Receipt of 20 mcg of the influenza vaccine VRC-FLUNPF081-00-VP (HA-F A/Sing, VRC 316, Group 1)
  9. * Receipt of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-v1, VRC 325)
  10. * Receipt of the mosaic hexavalent influenza vaccine VRC-FLUMOS0116-00-VP (FluMos-v2, VRC 326)
  11. * 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
  12. * Blood products within 16 weeks prior to enrollment
  13. * Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
  14. * Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
  15. * Current anti-TB prophylaxis or therapy
  16. * Participant has a history of any of the following clinically significant conditions:
  17. * Serious reactions to vaccines that preclude receipt of the study vaccinations as determined by the PI or designee
  18. * Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
  19. * Asthma that is not well controlled
  20. * Diabetes mellitus (type I or II), except for gestational diabetes
  21. * Thyroid disease that is not well controlled
  22. * Idiopathic urticaria within the past year
  23. * Immune-mediated diseases, such as autoimmune or autoinflammatory diseases, or immunodeficiencies
  24. * Hypertension that is not well controlled
  25. * 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
  26. * Malignancy that is active or history of malignancy that is likely to recur during the period of the study
  27. * 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
  28. * Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
  29. * Guillain-Barre Syndrome
  30. * 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.

Contacts and Locations

Study Contact

VRC Clinic
CONTACT
(301) 451-8715
vaccines@nih.gov

Principal Investigator

Lasonji A Holman, C.R.N.P.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Lasonji A Holman, C.R.N.P., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-28
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2025-04-28
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • Dose - Escalation
  • Immune Response
  • Viral Infection
  • Respiratory Illness
  • Experimental Vaccine
  • Experimental Adjuvant
  • Influenza Vaccine

Additional Relevant MeSH Terms

  • Influenza Prevention
  • Seasonal Influenza