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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT00537147
• Date of registration: 27/09/2007
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4delta30) in Healthy Adults
• Scientific title: 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
• Date of first enrolment: March 2008
• Target sample size: 26
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00537147
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Anna Durbin, M.D.
• Affiliation: Center for Immunization Research (CIR), Johns Hopkins School of Public Health

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

West Nile Fever

Intervention(s)

Biological: Placebo

Biological: WN/DEN4delta30 vaccine

Primary Outcome(s)

Frequency of vaccine-related adverse events, as classified by both intensity and severity through active and passive surveillance [Time Frame: Throughout study]

Immunogenicity, determined by anti-WN/DEN4 neutralizing antibody titer [Time Frame: At study entry, Days 28 and 42 after first vaccination, and Days 180, 208, and 222 after second vaccination]

Secondary Outcome(s)

Assess the frequency, quantity, and duration of viremia after each dose of vaccine by dose cohort (10^4 or 10^5 PFU) [Time Frame: Throughout study]

Compare the infectivity rates, safety, and immunogenicity between dose 1 and dose 2 within a cohort and between cohorts [Time Frame: At study completion]

Determine the number of vaccinees infected with WN/DEN4delta30 in each dose cohort (10^4 or 10^5 PFU) [Time Frame: Throughout study]

Secondary ID(s)

CIR 242

WIRB Protocol Number 20071891

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Johns Hopkins Bloomberg School of Public Health