ZIKA Vaccine in Naive Subjects
Condition: Zika Virus Infection
MeSH terms: Zika Virus Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      This study is a single-center, double-blinded, placebo-controlled, Phase 1 study to evaluate
      the safety, reactogenicity, and immunogenicity of ZPIV administered in a homologous
      prime-boost regimen to Flavivirus-naïve healthy male and non-pregnant female adult subjects.
      Three dose levels may be evaluated: 5.0 mcg, 2.5 mcg and 10mcg of ZPIV. Each subject will
      receive either placebo or ZPIV administered by intramuscular (IM) injection on Days 1 and 29.
      The study will consist of a screening period of up to 28 days, a vaccination period in which
      subjects will receive a prime dose of vaccine on Day 1 followed by a boost on Day 29, and a
      follow-up period of 12 months post boost vaccination. 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. The secondary objectives of this study are
      to 1. Assess the humoral immune response overall and by dosage group to a homologous
      prime-boost regimen of ZPIV as determined by kinetics of the immune responses, seroconversion
      rates, and peak Geometric Mean Titer (GMT) and to 2. Assess the durability of the humoral
      immune response overall and by dosage group to ZPIV at 6 and 12 months after the second
      vaccine administration.
    

Intervention name(s): Saline; Zika Virus Purified Inactivated Vaccine (ZPIV)
Intervention type(s): Drug; Biological
Intervention description(s): Sodium chloride solution.; Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Inactivated; Phase I; placebo-controlled; Vaccine; ZIKA