Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4delta30) in Healthy Adults
Phase 1 Study of the Safety and Immunogenicity of a 2-Dose Regimen of West Nile/Dengue 4-3'delta30 Chimeric Virus Vaccine (WN/DEN4delta30), a Live Attenuated Vaccine for West Nile Encephalitis
2 other identifiers
interventional
26
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2007
CompletedFirst Posted
Study publicly available on registry
September 28, 2007
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJanuary 3, 2013
December 1, 2012
1.3 years
September 27, 2007
December 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Frequency of vaccine-related adverse events, as classified by both intensity and severity through active and passive surveillance
Throughout study
Immunogenicity, determined by anti-WN/DEN4 neutralizing antibody titer
At study entry, Days 28 and 42 after first vaccination, and Days 180, 208, and 222 after second vaccination
Secondary Outcomes (3)
Assess the frequency, quantity, and duration of viremia after each dose of vaccine by dose cohort (10^4 or 10^5 PFU)
Throughout study
Determine the number of vaccinees infected with WN/DEN4delta30 in each dose cohort (10^4 or 10^5 PFU)
Throughout study
Compare the infectivity rates, safety, and immunogenicity between dose 1 and dose 2 within a cohort and between cohorts
At study completion
Study Arms (3)
1
EXPERIMENTAL1 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.
2
EXPERIMENTAL1 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.
3
PLACEBO COMPARATOR1 vaccination of a placebo administered as 0.5 ml subcutaneously in deltoid at study entry and Day 180.
Interventions
Eligibility Criteria
You may qualify if:
- Good general health
- Available for the duration of the trial
- Willing to use acceptable forms of contraception for the duration of the study
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Center for Immunization Research, Johns Hopkins School of Public Health (DC Location)
Washington D.C., District of Columbia, 20037, United States
Center for Immunization Research, Johns Hopkins School of Public Health (MD Location)
Baltimore, Maryland, 21205, United States
Related Publications (2)
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: 15056045BACKGROUNDPletnev 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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Durbin, M.D.
Center for Immunization Research (CIR), Johns Hopkins School of Public Health
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
September 27, 2007
First Posted
September 28, 2007
Study Start
March 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
January 3, 2013
Record last verified: 2012-12