Phase I Study of West Nile Virus Vaccine

NCT00300417 | Completed Phase 1

• 2 other identifiers: 06011006-I-0110
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the safety of an experimental vaccine for preventing West Nile virus infection. The virus is spread mainly by mosquito bites. Symptoms can include high fever, headache, neck stiffness, stupor, muscle weakness, vision loss, numbness and paralysis. Rarely, infection leads to permanent nerve damage and possibly death. The vaccine used in the study is made from DNA that codes for West Nile virus proteins. Injected into a muscle, the DNA instructs the body to make a small amount of West Nile virus protein. This study will see if the body creates resistance or immunity to these proteins. Participants cannot get West Nile virus from the vaccine. Healthy normal volunteers between 18 and 65 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests for various infections and other medical problems. Women who are able to become pregnant are given a pregnancy test. Women who are pregnant or breastfeeding may not participate. Anyone who has received a vaccination for Yellow Fever or Japanese Encephalitis virus in the past may not participate in this research study. Participants will receive three injections of the experimental vaccine, the first on the first study day (Day 0), the second on Day 28, and the third on Day 56. The injections are given with a device called Biojector® (Registered Trademark) 2000 that delivers the vaccine through the skin into the muscle without the use of a needle. On the day of each injection, subjects are given a diary card to take home for recording their temperature and any symptoms or side effects for 5 days. They return to the clinic 2 weeks after each injection, bringing the completed card with them at that time. In addition to the injections, subjects have the following tests and procedures during clinic visits:

• Medical history and, if needed, physical examination: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32
• Vital signs and weight: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32
• Lymph node exam: Day 0 and weeks 2, 4, 6, 8, 10, and 12
• Blood samples: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32
• Pregnancy test (for women): Day 0 and weeks 4, 8 and 32
• Urine sample: Day 0 and weeks 2, 4, 6, 8, and 10 The blood and urine tests are for health checks. Some blood samples are also used to study the immune response to the vaccine and for gene testing.

Conditions

West Nile Fever

Keywords

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

Interventions

VRC-WNVDNA020-00-VP DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A participant must meet all of the following criteria:
• to 65 years old.
• Available for clinical follow-up through Week 32 and contact (correspondence, telephone or e-mail) or clinical visit through Week 52 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 and genetic testing, including HLA analysis.
• In good general health without clinically significant medical history and has satisfactorily completed screening.
• Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 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.
• White blood cell (WBC) equal to 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:
• Breast-feeding or planning to become pregnant during the 32 weeks of study participation.
• Volunteer has received any of the following substances:
• Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past six months. (Note that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics are not excluded).
• 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

• Ledgerwood JE, Pierson TC, Hubka SA, Desai N, Rucker S, Gordon IJ, Enama ME, Nelson S, Nason M, Gu W, Bundrant N, Koup RA, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 303 Study Team. A West Nile virus DNA vaccine utilizing a modified promoter induces neutralizing antibody in younger and older healthy adults in a phase I clinical trial. J Infect Dis. 2011 May 15;203(10):1396-404. doi: 10.1093/infdis/jir054. Epub 2011 Mar 11.

  PMID: 21398392 DERIVED

MeSH Terms

Conditions

West Nile Fever

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; Virus 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 7, 2006
• First Posted: March 8, 2006
• Study Start: March 3, 2006
• Study Completion: December 28, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-12-28

Locations

US (1)