Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4-3’delta30) in Healthy Adults

Brief Title

Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4-3'delta30) in Healthy Adults

Official Title

Phase 1 Study of the Safety and Immunogenicity of West Nile/Dengue-4 3'delta30 Chimeric Virus Vaccine (WN/DEN4-3'delta30), a Live Attenuated Vaccine for West Nile Encephalitis

Brief Summary

      West Nile (WN) virus infection is an emerging disease; WN infection may lead to paralysis,
      coma, and death. The purpose of this study is to test the safety of and immune response to a
      WN vaccine in healthy adults. The vaccine is based on a live attenuated vaccine developed
      against dengue virus.
    

Detailed Description

      WN is widely distributed in Africa and Europe, where it is usually associated with mild
      illness. In the United States, WN is considered a public health threat because severe illness
      caused by WN infection has caused paralysis, coma, and death, especially in the elderly. This
      study will evaluate the safety and immunogenicity of a live attenuated chimeric virus,
      WN/DEN4-3'delta30, which is derived from the DEN4 dengue virus and wild-type WN serotypes.

      This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive
      the lowest dose of WN/DEN4-3'delta30 or placebo at study entry. Cohort 2 will begin only
      after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a
      higher dose of WN/DEN4-3'delta30 or placebo. Cohort 3 will begin only after safety review of
      all participants in Cohort 2. Participants in Cohort 3 will receive the highest dose of
      WN/DEN4-3'delta30 or placebo. Immediately after receiving their injections, participants will
      be observed for 30 minutes for immediate adverse reactions.

      After vaccination, participants will be asked to monitor their temperatures every day for 16
      days and on Day 19. Study visits will occur every other day after vaccination until Day 16,
      followed by 5 additional visits at selected days through Day 180. Blood collection and a
      targeted physical exam will occur at each study visit. Some participants will be asked to
      undergo a skin biopsy or additional blood collection at selected visits.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Frequency of vaccine-related adverse effects, graded by severity, for each dose

Secondary Outcome

 To assess the durability of the antibody response

Condition

West Nile Fever Encephalitis

Intervention

WN/DEN4-3'delta30

Study Arms / Comparison Groups

 1
Description:  One subcutaneous vaccination with WN/DEN4-3'delta30 vaccine (10^3 PFU dose) into the deltoid region of either arm.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

56

Start Date

February 2005

Completion Date

April 2005

Primary Completion Date

April 2005

Eligibility Criteria

        Inclusion Criteria:

          -  Willing to be followed for the duration of the study

          -  Willing to use acceptable methods of contraception

          -  Good general health

        Exclusion Criteria:

          -  Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic,
             autoimmune, or renal disease

          -  Behavioral, cognitive, or psychiatric disease that, in the opinion of the
             investigator, affects the ability of the volunteer to understand and cooperate with
             the study

          -  Hematologic disease

          -  History of migraine headaches

          -  History of encephalitis

          -  Alcohol or drug abuse within 12 months prior to study entry

          -  History of severe allergic reaction or anaphylaxis

          -  Emergency room visit or hospitalization for severe asthma within 6 months prior to
             study entry

          -  HIV-1 infected

          -  Hepatitis C virus infected

          -  Hepatitis B surface antigen positive

          -  Known immunodeficiency syndrome

          -  Use of corticosteroids or immunosuppressive drugs within 30 days of study entry.
             Participants who have used topical or nasal corticosteroids are not excluded.

          -  Live vaccine within 4 weeks prior to study entry

          -  Killed vaccine within 2 weeks prior to study entry

          -  Blood products within 6 months prior to study entry

          -  Participation in another investigational vaccine or drug trial within 60 days of
             starting this study, or while participating in this study

          -  Previously received a licensed or experimental yellow fever, tick-borne encephalitis,
             or dengue vaccine

          -  Surgical removal of spleen

          -  History of West Nile encephalitis

          -  History of dengue virus infection or other flavivirus infection (e.g., yellow fever
             virus, St. Louis encephalitis, West Nile virus)

          -  Other condition that, in the opinion of the investigator, would affect the
             participant's participation in the study

          -  Pregnancy or breastfeeding
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Anna Durbin, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00094718

Organization ID

CIR 206

Secondary IDs

H.22.04.10.06.A1

Responsible Party

Sponsor

Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

 Johns Hopkins Bloomberg School of Public Health

Study Sponsor

Anna Durbin, MD, Principal Investigator, Center for Immunization Research, Johns Hopkins School of Public Health


Verification Date

December 2012