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Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine, VRCFLUNPF099-00-VP, in Healthy Adults

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ClinicalTrials.gov Identifier: NCT03814720
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

Background:

The flu is a common viral infection that can be deadly for certain people. Vaccines against flu have been developed to teach the body to prevent or fight the infection. A new vaccine may help the body to make an immune response to H1 flu, a flu strain that infects humans.

Objective:

To test the safety and effectiveness of the H1 Stabilized Stem Ferritin vaccine (VRC-FLUNPF099-00-VP).

Eligibility:

Healthy people ages 18-70 years old who got at least 1 licensed flu vaccine since January 1, 2014.

Design:

Participants will have 1 or 2 vaccination visits over 4 months. Each will take about 4-6 hours.

They will get the vaccine by injections (shots) in the upper arm muscle.

Women who can get pregnant will have a pregnancy test before each injection.

After each vaccination, participants will complete a diary card for 7 days. They will record their temperature, skin changes, and any symptoms that they may have.

Participants will have 9-11 follow-up visits over 12-15 months. They will be checked for any health changes or problems. They will give blood samples and may give nose and throat swabs.

Participants may have apheresis. A needle will be placed into a vein in both arms. Blood will be removed through a needle in the vein of one arm. A machine will remove the white blood cells and then the rest of the blood is returned to the participant through a needle in the other arm.

Participants may sign a separate consent for genetic testing on their samples.


Condition or disease Intervention/treatment Phase
Influenza Biological: VRC-FLUNPF099-00-VP (H1ssF_3928) Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: VRC 321: A Phase I Open-Label Clinical Trial to Evaluate Dose, Safety, Tolerability, and Immunogenicity of an Influenza HI Stabilized Stem Ferritin Vaccine, VRCFLUNPF099-00 VP, in Healthy Adults
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Group 1
5 subjects, ages 18-40 will be administred 20 mcg IM of H1ssF 3928 on Day 0.
Biological: VRC-FLUNPF099-00-VP (H1ssF_3928)
The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/l999 (HlNl) genetically fused to the ferritin protein from H. pylori. Purified HlssF_3928 displays eight well-formed HA trimers that antigenically resemble the native Hl stem viral spikes.

Experimental: Group 2A
12 subjects, ages 18-40 will be administered 60 mcg IM of H1ssF 3928 on Day 0 and Week 16.
Biological: VRC-FLUNPF099-00-VP (H1ssF_3928)
The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/l999 (HlNl) genetically fused to the ferritin protein from H. pylori. Purified HlssF_3928 displays eight well-formed HA trimers that antigenically resemble the native Hl stem viral spikes.

Experimental: Group 2B
12 subjects, ages 41-49 will be administered 60 mcg IM of H1ssF 3928 on Day 0 and Week 16.
Biological: VRC-FLUNPF099-00-VP (H1ssF_3928)
The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/l999 (HlNl) genetically fused to the ferritin protein from H. pylori. Purified HlssF_3928 displays eight well-formed HA trimers that antigenically resemble the native Hl stem viral spikes.

Experimental: Group 2C
12 subjects, ages 50-59 will be administered 60 mcg IM of H1ssF 3928 on Day 0 and Week 16.
Biological: VRC-FLUNPF099-00-VP (H1ssF_3928)
The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/l999 (HlNl) genetically fused to the ferritin protein from H. pylori. Purified HlssF_3928 displays eight well-formed HA trimers that antigenically resemble the native Hl stem viral spikes.

Experimental: Group 2D
12 subjects, ages 60-70 will be administered 60 mcg IM of H1ssF 3928 on Day 0 and Week 16.
Biological: VRC-FLUNPF099-00-VP (H1ssF_3928)
The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/l999 (HlNl) genetically fused to the ferritin protein from H. pylori. Purified HlssF_3928 displays eight well-formed HA trimers that antigenically resemble the native Hl stem viral spikes.




Primary Outcome Measures :
  1. Evaluate the safety and tolerability [ Time Frame: 52 weeks following the vaccine administration and through an influenza season ]
    20 mcg of HlssF_3928 IM will be administered as a single dose to healthy adults.

  2. Evaluate safety and tolerability [ Time Frame: 52 weeks following the last vaccine administration and through an influenza season. ]
    60 mcg of HlssF_3928 IM will be administered by repeat dosing to healthy adults.


Secondary Outcome Measures :
  1. Evaluate antibody response [ Time Frame: 2 weeks post injection ]
    The antibody response to the VRC-FLUNPF099-00-VP vaccine administered as a 20 mcg single dose will be evaluated.

  2. Evaluate antibody response [ Time Frame: 2 weeks post each injection ]
    The antibody response to the VRC-FLUNPF099-00-VP vaccine administered as repeat dosing at 60 mcg IM will be evaluated.



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 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

    1. Healthy adults between the ages of 18-70 years inclusive
    2. Based on history and 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 2014 to the present
    4. Able and willing to complete the informed consent process
    5. If enrolled in Group 1: Available for clinic visits for 52 weeks after enrollment and through an influenza season
    6. If enrolled in Group 2A, 2B, 2C, or 2D: Available for clinic visits for 68 weeks after enrollment and through an influenza season
    7. Willing to have blood samples collected, stored indefinitely, and used for research purposes
    8. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
    9. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 28 days before enrollment

      Laboratory Criteria within 28 days before enrollment

    10. White blood cells (WBC) and differential either within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval
    11. Total lymphocyte count greater than or equal to 800 cells/mm^3
    12. Platelets = 125,000 - 500,000/mm3
    13. Hemoglobin within institutional normal range
    14. Serum iron either within institutional normal range or accompanied by the site PI or designee approval
    15. Serum ferritin within institutional normal range or accompanied by the site PI or designee approval
    16. Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit of normal (ULN)
    17. Aspartate aminotransferase (AST) less than or equal to 1.25 x institutional ULN
    18. Alkaline phosphatase (ALP) <1.1 x institutional ULN
    19. Total bilirubin within institutional normal range
    20. Serum creatinine less than or equal to 1.1 x institutional ULN
    21. Negative for HIV infection by an FDA-approved method of detection

      Criteria applicable to women of childbearing potential:

    22. Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on the day of enrollment
    23. 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:

  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 influenza vaccine
  10. Previous investigational ferritin-based vaccine
  11. Receipt of a licensed influenza vaccine within 6 weeks before trial enrollment

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

  12. Serious reactions to vaccines that preclude receipt of study vaccinations 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 (baseline systolic > 140 mmHg or diastolic > 90 mmHg)
  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. 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): NCT03814720


Contacts
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Contact: VRC Clinic (301) 451-8715 vaccines@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: Grace L Chen, 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: NCT03814720     History of Changes
Other Study ID Numbers: 190032
19-I-0032
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 13, 2019

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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) ):
Flu
Seasonal Allergy
Respiratory Illness
Flu Virus
Viral Infection
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs