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History of Changes for Study: NCT04896086
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.
Latest version (submitted July 6, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 20, 2021 None (earliest Version on record)
2 May 21, 2021 Study Status
3 May 22, 2021 Study Description, Study Status, Eligibility and Study Identification
4 May 25, 2021 Study Status
5 May 26, 2021 Study Status and Study Identification
6 October 7, 2021 Document Section and Study Status
7 October 8, 2021 Recruitment Status, Contacts/Locations, Study Status and References
8 October 13, 2021 Study Status
9 November 5, 2021 Study Status
10 March 15, 2022 IPDSharing and Study Status
11 March 16, 2022 Study Status
12 March 17, 2022 Study Status
13 March 18, 2022 Study Status
14 March 19, 2022 Study Status and Arms and Interventions
15 March 22, 2022 Study Status
16 March 23, 2022 Study Status
17 March 24, 2022 Study Status
18 March 25, 2022 Study Status
19 March 26, 2022 Study Status
20 March 30, 2022 Study Status
21 March 31, 2022 Study Status
22 April 1, 2022 Eligibility and Study Status
23 April 2, 2022 Study Status
24 April 5, 2022 Study Status
25 April 6, 2022 Study Status
26 April 7, 2022 Study Status
27 April 8, 2022 Study Status
28 April 9, 2022 Study Status
29 April 13, 2022 Study Status
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31 April 15, 2022 Study Status
32 April 16, 2022 Study Status
33 April 19, 2022 Study Status
34 April 20, 2022 Study Status
35 April 21, 2022 Study Status
36 April 22, 2022 Study Status
37 April 23, 2022 Study Design and Study Status
38 April 26, 2022 Study Status
39 April 27, 2022 Study Status
40 April 29, 2022 Study Status
41 May 2, 2022 Study Status
42 May 3, 2022 Study Status
43 May 4, 2022 Study Status
44 May 5, 2022 Study Status
45 May 6, 2022 Study Status
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70 June 13, 2022 Study Status
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72 June 15, 2022 Study Status
73 June 17, 2022 Arms and Interventions and Study Status
74 June 21, 2022 Study Status
75 June 22, 2022 Study Status
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78 June 27, 2022 Study Status
79 June 29, 2022 Study Status
80 June 30, 2022 Study Status
81 July 1, 2022 Study Status
82 July 5, 2022 Study Status
83 July 6, 2022 Study Status
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Study NCT04896086
Submitted Date:  May 20, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: 10000410
Brief 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.
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.
Secondary IDs: 000410-I
Open or close this module Study Status
Record Verification: May 19, 2021
Overall Status: Recruiting
Study Start: May 26, 2021
Primary Completion: May 1, 2023 [Anticipated]
Study Completion: May 1, 2023 [Anticipated]
First Submitted: May 20, 2021
First Submitted that
Met QC Criteria:
May 20, 2021
First Posted: May 21, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
May 20, 2021
Last Update Posted: May 21, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary:

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.

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.

Open or close this module Conditions
Conditions: Influenza
Seasonal Influenza
Keywords: Seasonal Influenza
Flu Virus
Respiratory Illness
Viral Infection
Experimental Vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
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-Barr(SqrRoot)(Copyright) 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.
Open or close this module Contacts/Locations
Central Contact Person: Floreliz H Mendoza
Telephone: (301) 451-8715
Email: mendozaf@mail.nih.gov
Study Officials: Alicia T Widge, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Locations: United States, Maryland
National Institutes of Health Clinical Center
[Recruiting]
Bethesda, Maryland, United States, 20892
Contact:Contact: VRC Clinic 301-451-8715 vaccines@nih.gov
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Lambert LC, Fauci AS. Influenza vaccines for the future. N Engl J Med. 2010 Nov 18;363(21):2036-44. doi: 10.1056/NEJMra1002842. Review. PubMed 21083388
Kanekiyo M, Joyce MG, Gillespie RA, Gallagher JR, Andrews SF, Yassine HM, Wheatley AK, Fisher BE, Ambrozak DR, Creanga A, Leung K, Yang ES, Boyoglu-Barnum S, Georgiev IS, Tsybovsky Y, Prabhakaran MS, Andersen H, Kong WP, Baxa U, Zephir KL, Ledgerwood JE, Koup RA, Kwong PD, Harris AK, McDermott AB, Mascola JR, Graham BS. Mosaic nanoparticle display of diverse influenza virus hemagglutinins elicits broad B cell responses. Nat Immunol. 2019 Mar;20(3):362-372. doi: 10.1038/s41590-018-0305-x. Epub 2019 Feb 11. Erratum in: Nat Immunol. 2019 Apr 12;:. PubMed 30742080
Links: Description: NIH Clinical Center Detailed Web Page
Available IPD/Information:

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