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First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults

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ClinicalTrials.gov Identifier: NCT04896086
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

Background:

Influenza (flu) is a contagious respiratory illness. It is caused by influenza viruses that infect the nose, throat, and sometimes the lungs. Vaccines are given to teach the body to prevent or fight infection. Researchers want to study a new vaccine to prevent the seasonal flu.

Objective:

To see if the FluMos-v1 vaccine is safe and how the body responds to it.

Eligibility:

Healthy adults ages 18-50 who received at least one licensed flu vaccine from 2016 through the 2019-2020 influenza season.

Design:

Participants will be screened through a separate protocol.

Participants will be tested for COVID-19. They may have a pregnancy test.

Participants will receive the FluMos-v1 vaccine or the Flucelvax vaccine. It will be injected in the upper arm.

Participants will complete a diary card for 7 days. They will record any symptoms they have. They will be given a thermometer to check their temperature. They will also be given a ruler to measure any skin changes at the injection site.

Participants will have about 10 study visits. They will be asked how they are feeling and if they have taken any medications. They will have blood drawn.

Participants will have oral mucosal samples collected using a thin swab. They may have nose and throat secretions collected using a thin swab.

Some participants will have optional apheresis. Blood will be removed through a needle in a vein in one arm. A machine will separate the white blood cells. The rest of the blood will be returned through a needle in a vein in the other arm.

Participation will last for 40 weeks.


Condition or disease Intervention/treatment Phase
Influenza Seasonal Influenza Biological: VRC-FLUMOS0111-00-VP (FluMos-v1) Biological: Flucelvax Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: VRC 325: A Phase I Open-Label Clinical Trial to Evaluate the Dose, Safety, Tolerability and Immunogenicity of Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, In Healthy Adults.
Actual Study Start Date : May 24, 2021
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Group 1A-1B
20 mcg of FluMos-v1
Biological: VRC-FLUMOS0111-00-VP (FluMos-v1)
The VRC-FLUMOS0111-00-VP (FluMos-v1) vaccine is composed of engineered pentamer yeast C. albicans lumazine synthase assembled with 20 HA ectodomain trimers from the following influenza strains: Influenza A (H1: A/Idaho/07/2018, H3: A/Perth/1008/2019) and Influenza B (B/Victoria lineage: B/Colorado/06/2017, B/Yamagata lineage: B/Phuket/3073/2013)

Experimental: Group 2A-2B
60 mcg of FluMos-v1
Biological: VRC-FLUMOS0111-00-VP (FluMos-v1)
The VRC-FLUMOS0111-00-VP (FluMos-v1) vaccine is composed of engineered pentamer yeast C. albicans lumazine synthase assembled with 20 HA ectodomain trimers from the following influenza strains: Influenza A (H1: A/Idaho/07/2018, H3: A/Perth/1008/2019) and Influenza B (B/Victoria lineage: B/Colorado/06/2017, B/Yamagata lineage: B/Phuket/3073/2013)

Active Comparator: Group 3A-3B
standard dose of 60 mcg of the licensed QIV Flucelvax
Biological: Flucelvax
Flucelvax is a cell-based vaccine which contains the same four influenza strains selected by the WHO, and has shown better safety and immunogenicity profiles that the traditional licensed seasonal egg based vaccine




Primary Outcome Measures :
  1. Serious adverse events [ Time Frame: Day 0 through Day 280 ]
    Occurrence of serious adverse events

  2. New chronic medical conditions [ Time Frame: Day 0 through Day 280 ]
    Occurrence of new-onset of chronic medical conditions

  3. Local Reactogenicity [ Time Frame: 7 days after product administration ]
    Occurrence of local reactogenicity signs and symptoms

  4. Unsolicited adverse events [ Time Frame: Day 0 through 28 days post product administration ]
    Occurrence of unsolicited non-serious adverse events

  5. Laboratory measures [ Time Frame: Day 0 through 28 days post product administration ]
    Occurrence of laboratory safety measures

  6. Systemic Reactogenicity [ Time Frame: 7 days after product administration ]
    Occurrence of systemic reactogenicity signs and symptoms


Secondary Outcome Measures :
  1. Group 1A-1B: vaccine-induced antibodies [ Time Frame: 2 weeks after product administration ]
    antibody responses to FluMos-v1

  2. Group 2A-2B: vaccine-induced antibodies [ Time Frame: 2 weeks after product administration ]
    antibody responses to FluMos-v1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

A subject must meet all of the following criteria:

  1. Healthy adults between the ages of 18-50 years inclusive
  2. Based on history and physical examination, in good general health and without history of any of the conditions listed in the exclusion criteria
  3. Received at least one licensed influenza vaccine from 2016 through the 2019-2020 influenza season
  4. Able and willing to complete the informed consent process
  5. Available for clinic visits for 40 weeks after enrollment and through an influenza season
  6. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
  7. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) <=35 within the 56 days before enrollment

    Laboratory Criteria within 56 days before enrollment

  8. White blood cells (WBC) and differential within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval
  9. Total lymphocyte count >=800 cells/microliter
  10. Platelets = 125,000 - 500,000 cells/microliter
  11. Hemoglobin within institutional normal range or accompanied by the PI or designee approval
  12. Alanine aminotransferase (ALT) <=1.25 x institutional upper limit of normal (ULN)
  13. Aspartate aminotransferase (AST) <=1.25 x institutional ULN
  14. Alkaline phosphatase (ALP) <1.1 x institutional ULN
  15. Total bilirubin within institutional normal range or accompanied by the PI or designee approval.
  16. Serum creatinine <=1.1 x institutional ULN
  17. Negative for HIV infection by an FDA-approved method of detection
  18. Negative for SARS-CoV-2 prior to enrollment

    Criteria applicable to women of childbearing potential:

  19. Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on the day of enrollment
  20. Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study

EXCLUSION CRITERIA:

A subject will be excluded if one or more of the following conditions apply:

  1. Breast-feeding or planning to become pregnant during the study

    Subject has received any of the following substances:

  2. 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
  3. Blood products within 16 weeks prior to enrollment
  4. Live attenuated vaccines within 4 weeks prior to enrollment
  5. Inactivated vaccines within 2 weeks prior to enrollment
  6. Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
  7. Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
  8. Current anti-TB prophylaxis or therapy
  9. Previous investigational H1, H2, or H10 influenza vaccines
  10. Groups 1A, 2A, and 3A only: Receipt of the 2020-2021 season s licensed influenza vaccine at any time prior to enrollment
  11. Groups 1B, 2B, and 3B only: Receipt of the 2020-2021 season s licensed influenza vaccine within 4 months prior to enrollment.

    Subject has a history of any of the following clinically significant conditions:

  12. Serious reactions to vaccines that preclude receipt of the study vaccination as determined by the investigator
  13. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
  14. Asthma that is not well controlled
  15. Diabetes mellitus (type I or II), with the exception of gestational diabetes
  16. Thyroid disease that is not well controlled
  17. Idiopathic urticaria within the past year
  18. Autoimmune disease or immunodeficiency
  19. Hypertension that is not well controlled
  20. 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
  21. Malignancy that is active or history of malignancy that is likely to recur during the period of the study
  22. 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
  23. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
  24. Guillain-Barre Syndrome
  25. Previous or current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) documented by PCR test
  26. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject s ability to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04896086


Contacts
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Contact: Floreliz H Mendoza (301) 451-8715 mendozaf@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: VRC Clinic    301-451-8715    vaccines@nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Alicia T Widge, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04896086    
Other Study ID Numbers: 10000410
000410-I
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 19, 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Seasonal Influenza
Flu Virus
Respiratory Illness
Viral Infection
Experimental Vaccine
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases