RECRUITING

Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (SteMos1) With and Without ALFQ Adjuvant in Healthy Adults

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Conditions

Influenza PreventionPandemic Influenza PreventionDose-EscalationINFLUENZA VIRUSImmune ResponseRespiratory IllnessExperimental VaccineSafety

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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: Influenza (flu) is a contagious respiratory illness caused by viruses. Flu symptoms can range from mild to severe, and the illness can be fatal. Vaccines help the body learn to prevent or fight infections such as flu. Some vaccines are combined with adjuvants. Adjuvants are special salts or fats that help vaccines work better. Researchers are looking for ways to make flu vaccines more effective. Objective: To test a new flu vaccine with and without a new adjuvant. Eligibility: Healthy adults aged 18 to 50. They must have had at least 1 flu vaccine since 2020. Design: Participants will have 12 clinic visits over 15 months. The vaccine is given as an injection into the muscle of the upper arm. Participants will be vaccinated during 2 visits spaced 4 months apart. Half will receive just the vaccine; half will receive the vaccine plus the adjuvant. They will be monitored for at least 30 minutes after each shot. Participants will keep a diary for 7 days after each shot. They check their temperature every day and record any symptoms. Participants will have 10 follow-up clinic visits plus 4 phone calls. They will have 4 to 10 tablespoons of blood drawn at each clinic visit. Fluid samples will be collected from their nose and mouth. They will be checked for any health changes. Participants may opt to undergo apheresis: Blood will be taken from the body through a needle inserted into a vein. 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 different needle.

Official Title

VRC 329: A Phase I Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (STEMos1) With and Without ALFQ Adjuvant in Healthy Adults

Quick Facts

Study Start:2025-08-18
Study Completion:2027-08-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07111078

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. * Healthy adults between the ages of 18-50 years, inclusive
  2. * 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
  3. * Received at least one licensed influenza vaccine from the 2020-2021 influenza season through the 2024-2025 influenza season
  4. * Able and willing to complete the informed consent process
  5. * The ability to read and comprehend English as all consent and recruitment materials are in English.
  6. * Available for clinic visits for 68 weeks after the first dose, 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 any 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. * WBC and differential within institutional normal range or accompanied by approval of the site Principal Investigator (PI) or designee
  12. * Total lymphocyte count \>= 800 cells/microliter
  13. * Platelets = 125,000-400,000 cells/mircoliter
  14. * Hemoglobin within institutional normal range or accompanied by approval of the PI or designee
  15. * Alanine aminotransferase (ALT) \<= 1.25 x institutional upper limit of normal (ULN)
  16. * Aspartate aminotransferase (AST) \<= 1.25 x institutional ULN
  17. * Alkaline phosphatase (ALP) \< 1.1 x institutional ULN
  18. * Total bilirubin within institutional normal range or accompanied by approval of the PI or designee
  19. * Serum creatinine \<= 1.1 x institutional ULN
  20. * Negative for HIV infection by an FDA-approved method of detection
  21. * Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on the day of enrollment
  22. * Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study
  1. * Receipt of any licensed influenza vaccine or lab-confirmed influenza infection within 6 months prior to enrollment.
  2. * Plan to or are required to receive the 2025-2026 or 2026-2027 licensed influenza vaccines
  3. * Live attenuated vaccines within 4 weeks prior to enrollment
  4. * Inactivated vaccines within 2 weeks prior to enrollment
  5. * mRNA vaccines within 4 weeks prior to enrollment
  6. * Receipt of the HA ferritin influenza vaccine VRC-FLUNPF081-00-VP alone or in primeboost regimens with VRC-FLUDNA082-00-VP (HA-F A/Sing, DNA A/Sing, VRC 316).
  7. * Receipt of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-v1, VRC 325)
  8. * Receipt of the mosaic hexavalent influenza vaccine VRC-FLUMOS0116-00-VP (FluMos-v2, VRC 326)
  9. * 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
  10. * Blood products within 16 weeks prior to enrollment
  11. * Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
  12. * Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
  13. * Current anti-TB prophylaxis or therapy
  14. * Serious reactions to vaccines that preclude receipt of the study vaccinations as determined by the PI or designee
  15. * Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
  16. * Asthma that is not well controlled
  17. * Diabetes mellitus (type I or II), except for gestational diabetes
  18. * Thyroid disease that is not well controlled
  19. * Idiopathic urticaria within the past year
  20. * Immune-mediated diseases, such as autoimmune or autoinflammatory diseases, or immunodeficiencies
  21. * Hypertension that is not well controlled
  22. * 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
  23. * Malignancy that is active or history of malignancy that is likely to recur during the period of the study
  24. * 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
  25. * Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
  26. * Guillain-Barre Syndrome
  27. * 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
Lesia K Dropulic, M.D.
CONTACT
(301) 412-2708
dropulicl@mail.nih.gov

Principal Investigator

Lesia K Dropulic, M.D.
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)

  • Lesia K Dropulic, M.D., 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 Date2025-08-18
Study Completion Date2027-08-18

Study Record Updates

Study Start Date2025-08-18
Study Completion Date2027-08-18

Terms related to this study

Keywords Provided by Researchers

  • Dose-Escalation
  • INFLUENZA VIRUS
  • Immune Response
  • Respiratory Illness
  • Experimental Vaccine
  • Safety

Additional Relevant MeSH Terms

  • Influenza Prevention
  • Pandemic Influenza Prevention