Clinical Trial: ZIKA Vaccine in Naive Subjects

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: Phase 1, Double-blinded, Placebo-Controlled Dose De-escalation Study of the Safety and Immunogenicity of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) Administered by the Intramuscula

Brief Summary: This study is a dose de-escalation study to evaluate the safety of ZPIV. Three dose levels may be evaluated. The entire duration of each subject's participation is approximately 14 months including recruitment and collection of data on the safety and reactogenicity of the study vaccine and samples for the assessment of immunogenicity. This study is expected to take approximately 30 months to complete from initiation through availability of a final report on the primary outcomes of safety and the secondary outcomes of humoral immunity to ZIKV. The Primary objectives of this study are to 1. Assess the safety and reactogenicity of a homologous prime boost regimen of ZPIV given at three different dose levels in a dose de-escalation format, and 2. Compare the safety and reactogenicity profile of ZPIV after each vaccination and between dosage groups.