This study is a 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 and 2. Compare the safety and
reactogenicity profile of ZPIV after each vaccination and between dosage groups.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)