Vaccine to Prevent West Nile Virus Disease

NCT00106769 | Completed Phase 1

• 2 other identifiers: 05012605-I-0126
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the safety of an experimental vaccine intended to prevent West Nile virus (WNV) infection and determine if it causes side effects. WNV symptoms may vary from fever and headache, to a polio-like syndrome with paralysis. Infection rarely results in death. The vaccine used in this study contains DNA that instructs the body to produce a small amount of a protein found in WNV. If the body creates resistance or immunity to these proteins, then the vaccine may protect against WNV. Study participants cannot get WNV from the vaccine. Healthy volunteers between 18 years and 50 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests, including a pregnancy test for women who can become pregnant. Patients undergo the following tests and procedures:

• Vaccine injections: Vaccines are given as injections in the upper arm, using a needleless system called the Biojector 2000. The first injection is on study day 0, the second on day 28 (+/-) 7 days, and the third on day 56 (+/-) 7 days. There must be at least 21 days between injections. The pregnancy test for women of childbearing potential is repeated the day of each vaccine injection.
• Diary card: Participants are given a 5-day diary card after each injection to record their temperature and any symptoms and side effects they may experience for up to 5 days after the injection. The diary cards are returned to the clinic at visits scheduled 2 weeks after each injection. Side effects and symptoms also must be reported immediately to a study nurse or doctor, and a clinic visit may be required for an examination.
• Clinic visits: At day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32, participants have a medical history, physical examination (if needed) and blood tests. Vital signs and weight are also recorded. Lymph nodes are examined at day 0 and weeks 2, 4, 6, 8, 10 and 12, and urine samples are collected at day 0 and weeks 2, 4, 6, 8 and 10. Some of the blood drawn during this study is used for genetic tests to see if different types of immune response to a vaccine are related to genetic differences in people.

Conditions

Healthy; West Nile Fever; Healthy Volunteer; HV

Keywords

Flavivirus; Mosquito; Immunity; Preventive; Virus; West Nile Fever; Healthy Volunteer; HV

Interventions

VRC-WNVDNA017-00-VP DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A participant must meet all of the following criteria:
• to 50 years old.
• Available for clinical follow-up through Week 32 of the study.
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly.
• Able and willing to complete the informed consent process.
• Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results.
• Willing to donate blood for sample storage to be used for future research.
• In good general health without clinically significant medical history and has satisfactorily completed screening.
• Physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment.
• Laboratory Criteria within 28 days prior to enrollment:
• Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men.
• WBC = 3,300-12,000 cells/mm(3).
• Absolute neutrophil count (ANC) within institutional normal range.
• Total lymphocyte count greater than or equal to 800 cells/mm(3).

You may not qualify if:

• A volunteer will be excluded if one or more of the following conditions apply:
• Women:
• Woman who is breast-feeding or planning to become pregnant during the 32 weeks of study participation.
• Volunteer has received any of the following substances:
• Immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis);
• Blood products within 120 days prior to HIV screening;
• Immunoglobulin within 60 days prior to HIV screening;
• Investigational research agents within 30 days prior to initial study vaccine administration;
• Live attenuated vaccines within 30 days prior to initial study vaccine administration;
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration;
• Current anti-TB prophylaxis or therapy.
• Volunteer has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.
• Autoimmune disease or immunodeficiency.
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.

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 (2)

• Centers for Disease Control and Prevention (CDC). West Nile virus activity--United States, September 29-October 5, 2004. MMWR Morb Mortal Wkly Rep. 2004 Oct 8;53(39):922-3.

  PMID: 15470326 BACKGROUND

• Martin JE, Pierson TC, Hubka S, Rucker S, Gordon IJ, Enama ME, Andrews CA, Xu Q, Davis BS, Nason M, Fay M, Koup RA, Roederer M, Bailer RT, Gomez PL, Mascola JR, Chang GJ, Nabel GJ, Graham BS. A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial. J Infect Dis. 2007 Dec 15;196(12):1732-40. doi: 10.1086/523650.

  PMID: 18190252 DERIVED

MeSH Terms

Conditions

West Nile Fever; Virus Diseases

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 29, 2005
• First Posted: March 30, 2005
• Study Start: March 22, 2005
• Study Completion: January 15, 2008
• Last Updated: July 2, 2017

Record last verified: 2008-01-15

Locations

US (1)