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Influenza HA Ferritin Vaccine, Alone or in Prime-Boost Regimens With an Influenza DNA Vaccine in Healthy Adults

This study is currently recruiting participants.
Verified October 2, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT03186781
First Posted: June 14, 2017
Last Update Posted: October 20, 2017
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.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
  Purpose

Background:

Influenza is a very common infectious disease. Influenza is also called flu. Vaccines teach the body to prevent or fight an infection. When the body learns to fight an infection, this is called an immune response. Researchers want to develop a vaccine against flu. They want to test two new vaccines to help the body make an immune response to flu.

Participants will get the vaccines (shots) in the upper arm muscle. One vaccine, the Influenza HA Ferritin vaccine, will be given to all participants with needle injection. The other vaccine, Influenza DNA vaccine, will be given to participants in Group 3 by a needle-free device that uses high pressure to push the vaccine through the skin and into the muscle.

Objective:

To test the safety and side effects of two new vaccines for prevention of H2 influenza (flu).

Eligibility:

Part I: Healthy adults at least 18 years old and born after 1969.

Part II: Healthy adults ages 18-70, but not born in 1966-1969.

Design:

Volunteer participants will be tested for eligibility in a screening study.

In Part I, all participants will get shots of HA Ferritin vaccine. Five participants in Group 1 will get one shot of low dose vaccine at Day 0 to test if it is safe and has no serious side effects. Then, five additional participants in Group 2 will get two shots of a higher dose at Day 0 and 4 months later.

Part II will study responses of adults born before 1966 and those born after 1969. Also, Part II will compare responses to 2 different vaccine plans. Group 3 will get a DNA Influenza vaccine at Day 0 and the HA Ferritin vaccine 4 months later. Group 4 will get HA Ferritin vaccine at Day 0 and 4 months later.

Participants will record their temperature and look at the injection site(s) each day for 7 days after each injection- they will write any symptoms at home on a paper diary or enter this data online.

Participants may choose to have leukapheresis. This is a procedure where the blood will be removed through a needle in an arm. A machine will separate some of the white blood cells from the blood. The rest of the blood will be returned through a needle into the other arm. The leukapheresis procedure lasts 3-4 hours.

There will be about 9 to 10 clinic visits over 10 months. At each visit, participants will be asked about health changes or problems. They will have a short physical exam. Blood will be taken. Participants might have extra visits and blood tests if they have changes in their health. Vaccination visits will last approximately 4-6 hours; other visits will last approximately 1 hour.


Condition Intervention Phase
Influenza Biological: VRC-FLUNPF081-00-VP (HA-F A/Sing) Biological: VRC-FLUDNA082-00-VP (DNA A/Sing) Phase 1

National Institute of Allergy and Infectious Diseases (NIAID) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: VRC 316: A Phase I Open-Label Clinical Trial To Evaluate Dose, Safety, Tolerability, And Immunogenicity Of An Influenza HA Ferritin Vaccine, Alone Or In Prime-Boost Regimens With An Influenza DNA Vaccine In Healthy Adults

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):

Primary Outcome Measures:
  • To evaluate the safety and tolerability of the HA-F A/Sing vaccine, administered as a single dose of 20 mcg IM. [ Time Frame: Through 40 weeks of study participation ]
  • To evaluate the safety and tolerability of the HA-F A/Sing vaccine, administered at 60 mcg IM. [ Time Frame: Through 40 weeks of study participation ]
  • To evaluate the safety and tolerability of the DNA A/Sing vaccine, administered as a single dose at 4 mg IM. [ Time Frame: Through 40 weeks of study participation ]

Secondary Outcome Measures:
  • Evaluation of antibody responses to two prime-boost vaccine regimens in healthy adults [ Time Frame: Two weeks after the boost ]
  • Compare the magnitude and the frequency of H2-specific antibody response as measured by HAI. [ Time Frame: Four weeks after the prime vaccine and two weeks after the boost ]

Estimated Enrollment: 80
Anticipated Study Start Date: October 25, 2017
Estimated Study Completion Date: April 24, 2019
Estimated Primary Completion Date: April 24, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low Dose. HA-FA/Sing, administered IM at a dosage of 20 mcg on Day 0
Biological: VRC-FLUNPF081-00-VP (HA-F A/Sing)
VRC-FLUNPF081-00-VP (HA-FA/Sing) is an investigational ferritin vaccine.
Experimental: 2
High Dose. HA-FA/Sing,administered IM at a dosage of 60 mcg Day 0 and Week 16
Biological: VRC-FLUNPF081-00-VP (HA-F A/Sing)
VRC-FLUNPF081-00-VP (HA-FA/Sing) is an investigational ferritin vaccine.
Experimental: 3
DNA A/Sing, administered IM at a dosage of 4 mg at Day 0 and HA-FA/Sing administered at a dosage of 60 mcg at Week 16
Biological: VRC-FLUDNA082-00-VP (DNA A/Sing)
VRC-FLUDNA082-00-VP (DNA A/Sing)is an investigational plasmid DNA vaccine.
Experimental: 4
HA-F A/Sing, administered IM at a dosage of 60 mcg at Day 0 and Week 16
Biological: VRC-FLUDNA082-00-VP (DNA A/Sing)
VRC-FLUDNA082-00-VP (DNA A/Sing)is an investigational plasmid DNA vaccine.

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

A subject must meet all of the following criteria:

  • Healthy subjects aged 18-70 (excluding subjects born between 1966-1969)
  • Based on history and examination, must be in good general health and without history of any of the conditions listed in the exclusion criteria
  • Received at least one licensed current seasonal influenza vaccine from 2014 to the present
  • Able and willing to complete the informed consent process
  • Available for clinic visits for 40 weeks after enrollment
  • Willing to have blood samples collected, stored indefinitely, and used for research purposes
  • Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
  • Physical examination and laboratory results without clinically significant findings and a

Body Mass Index (BMI) less than or equal to 40 within the 84 days before enrollment

Laboratory Criteria within 84 days before enrollment:

  • White blood cells (WBC) and differential either within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval
  • Total lymphocyte count greater than or equal to 800 cells/mm (3)
  • Platelets = 125,000 500,000/mm(3)
  • Hemoglobin within institutional normal range
  • Serum iron within institutional normal range
  • Alanine aminotransferase (ALT) less than or equal to 1.25 times institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) less than or equal to 1.25 times institutional ULN
  • Alkaline phosphatase (ALP) less than or equal to 1.1 times institutional ULN
  • Total bilirubin within institutional upper limit of normal (ULN)
  • Serum creatinine less than or equal to 1.1 times institutional ULN
  • Negative for HIV infection by an FDA approved method of detection

Criteria applicable to women of childbearing potential:

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

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

Subject has received any of the following substances:

  • 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
  • Blood products within 16 weeks prior to enrollment
  • Live attenuated vaccines within 4 weeks prior to enrollment
  • Inactivated vaccines within 2 weeks prior to enrollment.
  • Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
  • Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
  • Current anti-TB prophylaxis or therapy
  • Previous H2 influenza investigational vaccine
  • Receipt of a licensed influenza vaccine within 6 weeks before trial enrollment

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

  • Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator
  • Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
  • Asthma that is not well controlled
  • Diabetes mellitus (type I or II), with the exception of gestational diabetes
  • Thyroid disease that is not well controlled
  • Idiopathic urticaria within the past year
  • Evidence of autoimmune disease or immunodeficiency
  • Hypertension that is not well controlled
  • 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
  • Malignancy that is active or history of malignancy that is likely to recur during the period of the study.
  • 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
  • Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
  • Guillain-Barr(SqrRoot)(Copyright) Syndrome
  • Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within 5 years prior to enrollment, a history of suicide plan or attempt
  • 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.
  Contacts and Locations
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): NCT03186781


Contacts
Contact: VRC Clinic (301) 451-8715 vaccines@nih.gov

Locations
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
Principal Investigator: Grace L Chen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03186781     History of Changes
Other Study ID Numbers: 170110
17-I-0110
First Submitted: June 13, 2017
First Posted: June 14, 2017
Last Update Posted: October 20, 2017
Last Verified: October 2, 2017

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
Flu Shot
H2N2
Protein
Immune Response

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs