Evaluating the Safety and Immunogenicity of a Live Attenuated West Nile Virus Vaccine for West Ni… (NCT02186626) | Clinical Trial Compass
CompletedPhase 1
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
United States28 participantsStarted 2014-02
Plain-language summary
West Nile virus (WNV) is considered an emerging virus in the United States, and infection can lead to severe illness in older adults. This study will evaluate the safety of and immune response to a live West Nile virus vaccine (WN/DEN4Δ30) for the prevention of West Nile encephalitis in adults 50 to 65 years old.
Who can participate
Age range50 Years – 65 Years
SexALL
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Inclusion Criteria:
* Adult males and non-pregnant, non-breastfeeding females between 50 and 65 years of age, inclusive. Children will not be recruited or enrolled in this study for safety considerations.
* Good general health, as determined by means of the screening procedures
* Available for the duration of the trial
* Willingness to participate in the study as evidenced by signing the informed consent form (ICF)
Exclusion Criteria:
* Pregnancy, as determined by positive beta-human choriogonadotropin (HCG) test (if female)
* Currently lactating and breastfeeding (if female)
* Participant is unwilling to use reliable contraception methods for the duration of the trial (reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; intrauterine device; abstinence; and post-menopausal documented for at least 1 year). All female participants will be considered as having childbearing potential except for those with documented hysterectomy, tubal ligation, tubal coil (at least 3 months prior to vaccination), or who are post-menopausal for at least 1 year since last menstrual period.
* Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
* Behavioral, cognitive, or psychiatric disease that in the opinion of the in…
What they're measuring
1
Frequency of vaccine-related adverse events (AEs)
Timeframe: Measured through Day 360
2
Measurement of anti-WNV neutralizing antibody
Timeframe: Measured through Day 360
Trial details
NCT IDNCT02186626
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)