NCT00094718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2004

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

2 months

First QC Date

October 21, 2004

Last Update Submit

December 31, 2012

Conditions

West Nile Fever Encephalitis

Keywords

Chimeric Virus VaccineWest Nile VirusDengue Virus

Outcome Measures

Primary Outcomes (2)

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

    Throughout study

  • Immunogenicity of vaccine against WN virus

    Throughout study

Secondary Outcomes (5)

  • To assess the durability of the antibody response

    At Day 180

  • To assess the frequency, quantity, and duration of viremia in each dose cohort studied

    Throughout study

  • To assess the immunogenicity of the WN/DEN4-3'delta30 vaccine against WN wild-type virus

    Throughout study

  • To compare the T cell medicated immune response against West Nile virus of those volunteers infected with the WN/DEN4-3'delta30 vaccine virus with that of uninfected volunteers and placebo recipients

    At study completion

  • To evaluate the immunopathological mechanism of vaccine-associated rash in those volunteers who are willing to undergo skin biopsy

    Throughout study

Study Arms (4)

1

EXPERIMENTAL

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

Biological: WN/DEN4-3'delta30

2

EXPERIMENTAL

One subcutaneous vaccination with WN/DEN4-3'delta30 vaccine (10\^4 PFU dose) into the deltoid region of either arm. This arm may enroll after the results from Arm 1 are analyzed.

Biological: WN/DEN4-3'delta30

3

EXPERIMENTAL

One subcutaneous vaccination with WN/DEN4-3'delta30 vaccine (10\^5 PFU dose) into the deltoid region of either arm. This arm may enroll after the results from Arm 2 are analyzed.

Biological: WN/DEN4-3'delta30

4

PLACEBO COMPARATOR

One subcutaneous vaccination with placebo vaccine into the deltoid region of either arm.

Biological: Placebo

Interventions

WN/DEN4-3'delta30BIOLOGICAL

Live attenuated WN/DEN4-3'delta30 vaccine (one of three doses)

123
PlaceboBIOLOGICAL

Placebo for WN/DEN4-3'delta30 vaccine

4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Willing to be followed for the duration of the study
  • Willing to use acceptable methods of contraception
  • Good general health

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

Vanderbilt University School of Medicine

Nashville, Tennessee, 37232, United States

Location

Related Publications (5)

  • Chang GJ, Kuno G, Purdy DE, Davis BS. Recent advancement in flavivirus vaccine development. Expert Rev Vaccines. 2004 Apr;3(2):199-220. doi: 10.1586/14760584.3.2.199.

    PMID: 15056045BACKGROUND

  • Lai CJ, Monath TP. Chimeric flaviviruses: novel vaccines against dengue fever, tick-borne encephalitis, and Japanese encephalitis. Adv Virus Res. 2003;61:469-509. doi: 10.1016/s0065-3527(03)61013-4.

    PMID: 14714441BACKGROUND

  • Monath TP, McCarthy K, Bedford P, Johnson CT, Nichols R, Yoksan S, Marchesani R, Knauber M, Wells KH, Arroyo J, Guirakhoo F. Clinical proof of principle for ChimeriVax: recombinant live, attenuated vaccines against flavivirus infections. Vaccine. 2002 Jan 15;20(7-8):1004-18. doi: 10.1016/s0264-410x(01)00457-1.

    PMID: 11803060BACKGROUND

  • Pletnev AG, Claire MS, Elkins R, Speicher J, Murphy BR, Chanock RM. Molecularly engineered live-attenuated chimeric West Nile/dengue virus vaccines protect rhesus monkeys from West Nile virus. Virology. 2003 Sep 15;314(1):190-5. doi: 10.1016/s0042-6822(03)00450-1.

    PMID: 14517072BACKGROUND

  • Pugachev KV, Guirakhoo F, Trent DW, Monath TP. Traditional and novel approaches to flavivirus vaccines. Int J Parasitol. 2003 May;33(5-6):567-82. doi: 10.1016/s0020-7519(03)00063-8.

    PMID: 12782056BACKGROUND

MeSH Terms

Conditions

West Nile Fever

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesMosquito-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Officials

  • Anna Durbin, MD

    Center for Immunization Research, Johns Hopkins School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2004

First Posted

October 22, 2004

Study Start

February 1, 2005

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

January 3, 2013

Record last verified: 2012-12

Locations

US(2)