Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4delta30) in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00094718

West Nile Fever Encephalitis

COMPLETED PHASE1

Evaluating the Safety and Immunogenicity of a Live Attenuated West Nile Virus Vaccine for West Nile Encephalitis in Adults 50 to 65 Years of Age

NCT02186626

West Nile Virus

COMPLETED PHASE1

Phase I Study of West Nile Virus Vaccine

NCT00300417

West Nile Fever

COMPLETED PHASE1

Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-4995) in Healthy Adults

NCT00322946

Dengue

COMPLETED PHASE1

Safety of and Immune Response to DEN4 Vaccine Component Candidate for Dengue Virus

NCT00919178

Dengue Shock Syndrome Dengue Hemorrhagic Fever

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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/DEN4delta30, which is derived from the DEN4 dengue virus and wild-type WN serotypes.

This study will last at least 32 weeks. Participants in Cohort 1 will be randomly assigned to receive 1X10\^4 plaque-forming units (PFU) WN/DEN4delta30 or placebo at study entry and Day 180. Cohort 2 will be randomly assigned to receive a higher dose of WN/DEN4delta30, 10\^5 PFU, or placebo at study entry and Day 180. Immediately after receiving their injections, participants will be observed for 30 minutes for immediate adverse reactions.

After each vaccination, participants will be asked to monitor their temperatures three times every day for 16 days. Study visits will occur every other day after each vaccination until Day 16, followed by three additional visits at selected days through Day 180 post-vaccination. Blood collection, medical history, vital signs measurement, and a targeted physical exam will occur at all visits. Participants will also be required to keep temperature diaries until Day 16 after vaccination. Female participants will have a urine pregnancy test performed within 60 days of study entry, and on Days 28, 42, 150, 180, 208, and 222. Pregnancy prevention counseling will occur at selected visits.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

West Nile Fever

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

1 vaccination of a 10\^4 plaque-forming units (PFU) dose of WN/DEN4delta30 vaccine administered as 0.5 ml subcutaneously in deltoid at study entry and Day 180.

Group Type EXPERIMENTAL

WN/DEN4delta30 vaccine

Intervention Type BIOLOGICAL

Live attenuated WN/DEN4delta30 vaccine (one of two doses)

2

1 vaccination of a 10\^5 PFU dose of WN/DEN4delta30 vaccine administered as 0.5 ml subcutaneously in deltoid at study entry and Day 180.

Group Type EXPERIMENTAL

WN/DEN4delta30 vaccine

Intervention Type BIOLOGICAL

Live attenuated WN/DEN4delta30 vaccine (one of two doses)

3

1 vaccination of a placebo administered as 0.5 ml subcutaneously in deltoid at study entry and Day 180.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo for WN/DEN4delta30 vaccine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

WN/DEN4delta30 vaccine

Live attenuated WN/DEN4delta30 vaccine (one of two doses)

Intervention Type BIOLOGICAL

Placebo

Placebo for WN/DEN4delta30 vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Good general health
* Available for the duration of the trial
* Willing to use acceptable forms of contraception for the duration of the study

Exclusion Criteria

* Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney 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
* Neutropenia (abnormally low neutrophil count)
* Alcohol or drug abuse within 12 months prior to study entry
* Elevated levels of alanine aminotransferase (ALT) and serum creatinine
* History of severe allergic reaction or anaphylaxis
* Severe asthma
* 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
* Surgical removal of spleen
* Blood products within 6 months prior to study entry
* History of dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus)
* Previously received a licensed or experimental yellow fever or dengue vaccine
* Investigational agent within 30 days of study entry
* Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
* Pregnancy or breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes