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Trial record 2 of 2 for:    COVID | MOSAIC

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04896086
Recruitment Status : Active, not recruiting
First Posted : May 21, 2021
Last Update Posted : May 27, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Tracking Information
First Submitted Date  ICMJE May 20, 2021
First Posted Date  ICMJE May 21, 2021
Last Update Posted Date May 27, 2022
Actual Study Start Date  ICMJE May 24, 2021
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2021)
  • Serious adverse events [ Time Frame: Day 0 through Day 280 ]
    Occurrence of serious adverse events
  • New chronic medical conditions [ Time Frame: Day 0 through Day 280 ]
    Occurrence of new-onset of chronic medical conditions
  • Local Reactogenicity [ Time Frame: 7 days after product administration ]
    Occurrence of local reactogenicity signs and symptoms
  • Unsolicited adverse events [ Time Frame: Day 0 through 28 days post product administration ]
    Occurrence of unsolicited non-serious adverse events
  • Laboratory measures [ Time Frame: Day 0 through 28 days post product administration ]
    Occurrence of laboratory safety measures
  • Systemic Reactogenicity [ Time Frame: 7 days after product administration ]
    Occurrence of systemic reactogenicity signs and symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2021)
  • Group 1A-1B: vaccine-induced antibodies [ Time Frame: 2 weeks after product administration ]
    antibody responses to FluMos-v1
  • Group 2A-2B: vaccine-induced antibodies [ Time Frame: 2 weeks after product administration ]
    antibody responses to FluMos-v1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults
Official Title  ICMJE 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.
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.

Detailed Description

This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-v1). The hypotheses are that the FluMos-v1 vaccine is safe and tolerable and will elicit an immune response. The primary objective is to evaluate the safety and tolerability of the investigational vaccine in healthy adults. Secondary objectives are related to immunogenicity of the investigational vaccine and dosing regimen compared with the licensed inactivated seasonal Flucelvax (Registered Trademark) quadrivalent influenza vaccine (QIV) in Healthy Adults.

The investigational vaccine FluMos-v1 was developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID) and is composed of the following 4 influenza strains:

Influenza A:

H1: A/Idaho/07/2018

H3: A/Perth/1008/2019

Influenza B:

B/Victoria lineage: B/Colorado/06/2017

B/Yamagata lineage: B/Phuket/3073/2013

FluMos-v1 is supplied in a single-use vial at a concentration of 180 mcg/mL.

The FDA licensed inactivated 2020-2021 QIV Flucelvax(Registered Trademark) was developed by Seqirus, Inc. and is composed of the following 4 influenza strains:

Influenza A:

H1: A/Hawaii/70/2019 (H1N1) pdm09-like virus

H3: A/Hong Kong/45/2019 (H3N2)-like virus

Influenza B:

B/Victoria lineage: B/Washington/02/2019-like virus

B/Yamagata lineage: B/Phuket/3073/2013-like virus

Flucelvax(Registered Trademark) is supplied in a single-use syringe at 15 mcg HA of each of the four influenza strains, for a total of 60 mcg HA per 0.5 mL dose.

FluMos-v1 and Flucelvax(Registered Trademark) will be administered intramuscularly (IM) in the deltoid muscle via needle and syringe.

Healthy adults between the ages of 18-50 years inclusive will be enrolled.

The study will evaluate the safety, tolerability and immunogenicity of a single dose of FluMos-v1 vaccine in a dose-escalation design. In Group 1A-1B, five subjects will receive a dose of 20 mcg of FluMos-v1. If the 20 mcg dose is assessed as safe and tolerable, enrollment will begin for Group 2A-2B.

In Group 2A-2B, subjects will receive a dose of 60 mcg of FluMos-v1. In Group 3A-3B, subjects will receive the licensed QIV Flucelvax(Registered Trademark) and may enroll at any time after the study is open to accrual.

The protocol requires 1 vaccination visit, about 8 follow-up visits, and a telephone contact on the day after vaccination. For all groups, solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study.

Subjects will be evaluated for 40 weeks following vaccine administration and through an influenza season.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Influenza
  • Seasonal Influenza
Intervention  ICMJE
  • 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)
  • 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 than the traditional licensed seasonal egg-based vaccine.
Study Arms  ICMJE
  • Experimental: Group 1A-1B
    20 mcg of FluMos-v1
    Intervention: Biological: VRC-FLUMOS0111-00-VP (FluMos-v1)
  • Experimental: Group 2A-2B
    60 mcg of FluMos-v1
    Intervention: Biological: VRC-FLUMOS0111-00-VP (FluMos-v1)
  • Active Comparator: Group 3A-3B
    standard dose of 60 mcg of the licensed QIV Flucelvax
    Intervention: Biological: Flucelvax
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 23, 2022)
35
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2021)
40
Estimated Study Completion Date  ICMJE May 1, 2023
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04896086
Other Study ID Numbers  ICMJE 10000410
000410-I
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: .Only aggregate data will be shared.
Current Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alicia T Widge, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date April 22, 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP