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Dose, Safety, Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine, VRC-FLUNPF0103-00-VP, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04579250
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : November 19, 2020
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 lungs. Some people, such as older people, young children, and people with certain health conditions, are at high risk of serious flu complications. Researchers want to test a vaccine to prevent flu.

Objective:

To see if the H10 Ferritin vaccine is safe and how the body responds to it.

Eligibility:

Healthy adults ages 18-70.

Design:

Participants will be screened with:

Medical history

Physical exam

Blood tests

Pregnancy test (if needed).

Participants will get 1-2 injections of the study vaccine in the upper arm. They will stay in the clinic for at least 30 minutes after each vaccination.

Participants will keep a diary card for 7 days after each vaccination. They will record their temperature and any symptoms. They will measure any skin changes at the injection site.

Participants may have nose and throat secretions, and/or oral mucosal samples, collected with a disposable swab.

Participants will have blood drawn.

Some participants may have apheresis. A needle is placed into a vein in both arms. Blood is removed through a needle in the vein of one arm. The blood is spun in a machine that separates the white blood cells. The rest of the blood is returned to the participant through a needle in the other arm. Before apheresis, participants weight, pulse, and blood pressure will be checked. Their medical history will be taken.

Participants will have 8-10 follow-up visits. Participation will last about 10 months.


Condition or disease Intervention/treatment Phase
Influenza Biological: VRC-FLUNPF0103-00-VP VRC-FLUNPF0103-00-VP (H10ssF-6473) Phase 1

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: VRC 323: A Phase I Open-Label Clinical Trial to Evaluate the Dose, Safety, Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine, VRC-FLUNPF0103-00-VP, in Healthy Adults
Actual Study Start Date : October 8, 2020
Estimated Primary Completion Date : December 31, 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
20 mcg IM at Day 0
Biological: VRC-FLUNPF0103-00-VP VRC-FLUNPF0103-00-VP (H10ssF-6473)
The vaccine is composed of the HA stem domain from A/Jiangxi/IPB13/2013 (H10N8) influenza genetically fused to the ferritin protein from H. pylori. Purified H10ssF-6473 displays eight well-formed HA trimers that antigenically resemble the native H10 stem viral spikes.

Experimental: Group 2A
60 mcg IM at Day 0 and Week 16
Biological: VRC-FLUNPF0103-00-VP VRC-FLUNPF0103-00-VP (H10ssF-6473)
The vaccine is composed of the HA stem domain from A/Jiangxi/IPB13/2013 (H10N8) influenza genetically fused to the ferritin protein from H. pylori. Purified H10ssF-6473 displays eight well-formed HA trimers that antigenically resemble the native H10 stem viral spikes.

Experimental: Group 2B
60 mcg IM at Day 0 and Week 16
Biological: VRC-FLUNPF0103-00-VP VRC-FLUNPF0103-00-VP (H10ssF-6473)
The vaccine is composed of the HA stem domain from A/Jiangxi/IPB13/2013 (H10N8) influenza genetically fused to the ferritin protein from H. pylori. Purified H10ssF-6473 displays eight well-formed HA trimers that antigenically resemble the native H10 stem viral spikes.




Primary Outcome Measures :
  1. Local Reactogenicity [ Time Frame: 7 days after each product administration ]
    Occurrence of local reactogenicity signs and symptoms

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

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

  4. Serious adverse events [ Time Frame: Day O through Day 28O ]
    Occurrence of serious adverse events

  5. New chronic medical conditions [ Time Frame: Day O through Day 28O ]
    Occurrence of new-onset of chronic medical conditions

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


Secondary Outcome Measures :
  1. Group 1: vaccine-induced antibodies [ Time Frame: Day O and 28 days post product administration ]
    Stem-specific antibody responses to HlOssF-6473

  2. Group 2A-2B: vaccine-induced antibodies [ Time Frame: Day O and 2 weeks after each product administration ]
    Stem-specific antibody responses to HlOssF-6473



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:

A subject must meet all of the following criteria:

  1. Healthy adults between the ages of 18-70 years (excluding adults born between January 1, 1965 and December 31,1970)
  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 2015 to the present
  4. Able and willing to complete the informed consent process
  5. Available for clinic visits for 40 weeks after enrollment
  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) less than or equal to 40 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 greater than or equal to 800 cells/microL
  10. Platelets = 125,000 - 500,000 cells/microL
  11. Hemoglobin within institutional normal range or accompanied by the PI or designee approval
  12. Serum iron within institutional normal range or accompanied by the site PI or designee approval
  13. Serum ferritin within institutional normal range or accompanied by the site PI or designee approval
  14. Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit of normal (ULN)
  15. Aspartate aminotransferase (AST) less than or equal to 1.25 x institutional ULN
  16. Alkaline phosphatase (ALP) <1.1 x institutional ULN
  17. Total bilirubin within institutional normal range, except when otherwise consistent with Gilbert s syndrome
  18. Serum creatinine less than or equal to 1.1 x institutional ULN
  19. Negative for HIV infection by an FDA-approved method of detection

    Criteria applicable to women of childbearing potential:

  20. Negative beta-human chorionic gonadotropin (Beta-HCG) pregnancy test (urine or serum) on the day of enrollment
  21. 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 H10 influenza vaccine
  10. Receipt of a licensed influenza vaccine within 6 weeks prior to enrollment

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

  11. Serious reactions to vaccines that preclude receipt of the study vaccination as determined by the investigator
  12. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
  13. Asthma that is not well controlled
  14. Diabetes mellitus (type I or II), with the exception of gestational diabetes
  15. Thyroid disease that is not well controlled
  16. Idiopathic urticaria within the past year
  17. Autoimmune disease or immunodeficiency
  18. Hypertension that is not well controlled (baseline systolic > 140 mmHg or diastolic > 90 mmHg)
  19. 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
  20. Malignancy that is active or history of malignancy that is likely to recur during the period of the study
  21. 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
  22. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
  23. Guillain-Barre Syndrome
  24. Previous or current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) documented by PCR test
  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.

INCLUSION OF VULNERABLE SUBJECTS

Children

Children are not eligible to participate in this clinical trial because the investigational vaccine has not been previously evaluated in adults. If the product is assessed as safe and immunogenic, other protocols designed for children may be conducted in the future.

NIH Employees

NIH employees and members of their immediate families may participate in this protocol. We will follow the Guidelines for the Inclusion of Employees in NIH Research Studies and will give each employee a copy of the 'NIH Information Sheet on Employee Research Participation' and a copy of the 'Leave Policy for NIH Employees Participating in NIH Medical Research Studies.'

Neither participation nor refusal to participate will have an effect, either beneficial or adverse, on the participant s employment or work situation. The NIH information sheet regarding NIH employee research participation will be distributed to all potential subjects who are NIH employees. The employee subject s privacy and confidentiality will be preserved in accordance with NIH CC and NIAID policies. For NIH employee subjects, consent will be obtained by an individual who is independent of the employee s team. If the individual obtaining consent is a co-worker to the subject, independent monitoring of the consent process will be included through the Bioethics Consultation Service. Protocol study staff will be trained on obtaining potentially sensitive and private information from co-workers or subordinates.


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): NCT04579250


Contacts
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Contact: Pamela Costner, R.N. (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: Joseph P Casazza, 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: NCT04579250    
Other Study ID Numbers: 200145
20-I-0145
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 17, 2020

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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 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