H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or With Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime With MIV Boost Compared to MIV Prime With MIV Boo...

NCT02206464 | Completed Phase 1

• 2 other identifiers: 14016014-I-0160
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background:\<TAB\> \- Flu virus that causes disease in birds can sometimes spread to people. It can cause severe illness, even death. Vaccines are used to try to create resistance to such infections. Researchers want to test a new vaccination strategy, combining two different vaccine types, the H7 DNA Vaccine (DNA vaccine) and H7N9 Monovalent Inactivated Vaccine (MIV), to see if one of two combinations offer better protection against a certain type of bird flu in humans when compared to vaccination using two doses of MIV alone. Objectives:

• To see if 2 vaccines for bird flu, are safe and tolerable for humans.
• To study immune responses to these vaccines. Eligibility: \- Healthy adults 18 60 years old. Design:
• Participants will be screened through a separate protocol.
• Participants will be randomly assigned to 1 of 3 groups. Each group will get a different combination of vaccines.
• Participants will have about 8 clinic visits. Each visit takes 2 4 hours. Blood will be drawn at some visits. Urine samples may be collected.
• Participants will receive vaccinations at 2 of the visits, 16 weeks apart.
• The H7N9 MIV will be injected in the upper arm using a needle and syringe. The DNA vaccine will be injected in the upper arm using a device that delivers the vaccine through the skin by pressure instead of a needle.
• Participants will be observed for at least 30 minutes after each vaccination.
• Soon after each vaccination, participants will get 1 2 phone calls, come to clinic for evaluation, and complete a diary at home for 1 week. They will record their temperature and symptoms and look at the injection site daily.
• Participants will have follow-up blood tests.

Conditions

Influenza

Keywords

A/Anhui/1/2013 (H7N9); Antibody Response; Avian Influenza; A/Shanghai/2/2013 (H7N9); Immunogenicity

Outcome Measures

Primary Outcomes (3)

• Solicited adverse events (reactogenicity).

  Daily for 7 days following each vaccination.

• Adverse events of all severities.

  Through 28 days after each injection.

• Serious adverse events, new chronic medical conditions and influenza-like illnesses

  From first vaccination to last study visit

Secondary Outcomes (1)

• H7-specific antibody response as measured by HAI assay

  Day 0 (baseline) and 2 weeks after the boost vaccination.

Study Arms (3)

Group 1

EXPERIMENTAL

H7 DNA vaccine on Day 0 and H7N9 MIV at StudyWeek 16

Biological: A/Shanghai/02/2013 (H7N9) MIV; Biological: VRC-FLUDNA071-00-VP

Group 2

EXPERIMENTAL

H7 DNA and H7N9 MIV administered on Day 0 and H7N9 MIV boost at Study Week 16

Biological: A/Shanghai/02/2013 (H7N9) MIV; Biological: VRC-FLUDNA071-00-VP

Group 3

EXPERIMENTAL

H7N9 MIV on Day 0 and H7N9 MIV at Study Week 16

Biological: A/Shanghai/02/2013 (H7N9) MIV; Biological: VRC-FLUDNA071-00-VP

Interventions

A/Shanghai/02/2013 (H7N9) MIV BIOLOGICAL

Monovalent Influenza Subvirion Vaccine for H7N9 avian influenza (H7N9 MIV)

Group 1; Group 2; Group 3

VRC-FLUDNA071-00-VP BIOLOGICAL

H7 DNA Vaccine

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A subject must meet all of the following criteria:
• to 60 years old.
• Available for clinic visits for up to 28 weeks after enrollment.
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• Willing to donate blood for sample storage to be used for future research.
• In good general health without clinically significant medical history.
• Received a current seasonal influenza vaccine at least 2 weeks before enrollment.
• 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 prior to enrollment.
• Laboratory Criteria within 56 days prior to enrollment:
• Hemoglobin within institutional normal limits
• White blood cells (WBC) and differential either within institutional normal range or accompanied by site physician approval
• Total lymphocyte count greater than or equal to 800 cells/mm3
• Platelets = 125,000 500,000/mm3
• Alanine aminotransferase (ALT) less than or equal to 1.25 x upper limit of normal (ULN)
• Serum creatinine less than or equal to .1 x ULN based on the institutional normal range

You may not qualify if:

• A subject will be excluded if one or more of the following conditions apply. Women Specific:
• Breast-feeding or planning to become pregnant while participating in 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 initial study vaccine administration
• Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal within 2 weeks of initial study vaccine administration unless approved by the study Principal Investigator (PI)
• Allergy treatment with antigen injections, unless on maintenance schedule
• Current anti-TB prophylaxis or therapy
• Previous H7 avian influenza investigational vaccine
• Subject has a history of any of the following clinically significant conditions:
• Contraindication to receiving an FDA-approved current seasonal influenza vaccination including hypersensitivity to eggs
• Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator
• Hereditary angioedema, acquired angioedema, or idiopathic forms of Angioedema

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Ledgerwood JE, Graham BS. DNA vaccines: a safe and efficient platform technology for responding to emerging infectious diseases. Hum Vaccin. 2009 Sep;5(9):623-6. doi: 10.4161/hv.8627. No abstract available.

  PMID: 19779298 BACKGROUND

• Ledgerwood JE, Wei CJ, Hu Z, Gordon IJ, Enama ME, Hendel CS, McTamney PM, Pearce MB, Yassine HM, Boyington JC, Bailer R, Tumpey TM, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 306 Study Team. DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials. Lancet Infect Dis. 2011 Dec;11(12):916-24. doi: 10.1016/S1473-3099(11)70240-7. Epub 2011 Oct 3.

  PMID: 21975270 BACKGROUND

• Ledgerwood JE, Zephir K, Hu Z, Wei CJ, Chang L, Enama ME, Hendel CS, Sitar S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 310 Study Team. Prime-boost interval matters: a randomized phase 1 study to identify the minimum interval necessary to observe the H5 DNA influenza vaccine priming effect. J Infect Dis. 2013 Aug 1;208(3):418-22. doi: 10.1093/infdis/jit180. Epub 2013 Apr 30.

  PMID: 23633407 BACKGROUND

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Bird Diseases; Animal Diseases

Study Officials

• Julie E Ledgerwood, D.O.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 1, 2014
• Study Start: July 29, 2014
• Primary Completion: January 7, 2016
• Study Completion: January 7, 2016
• Last Updated: December 17, 2019

Record last verified: 2016-01-07

Locations

US (1)