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.
Age range
18 Years – 49 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Comparison between dosage groups of the duration of vaccine-related Grade 2 or greater local or systemic reactogenicity
Timeframe: 8 Days after each vaccination
Comparison between dosage groups of the duration overall and in each dosage group of vaccine-related Grade 3 local, systemic, or laboratory AE
Timeframe: 8 Days after each vaccination
Comparison between dosage groups of the frequency of vaccine-related Grade 2 or greater local or systemic reactogenicity
Timeframe: 8 Days after each vaccination
Comparison between dosage groups of the frequency of vaccine-related Grade 3 local, systemic, or laboratory AE
Timeframe: 8 Days after each vaccination
Comparison between dosage groups of the type of vaccine-related Grade 2 or greater local or systemic reactogenicity
Timeframe: 8 Days after each vaccination
Comparison between dosage groups of the type overall and each dosage group of vaccine-related Grade 3 local, systemic, or laboratory AE
Timeframe: 8 Days after each vaccination
Comparison of study withdrawals, and discontinuation of study vaccination due to any reason between dosage groups.
Timeframe: 14 Months
Duration overall and in each dosage group of serious adverse events (SAE) and adverse events of special interest (AESI) considered related to study vaccination
Timeframe: 14 Months
Frequency of new onset chronic medical conditions
Timeframe: 14 Months
Frequency overall and in each dosage group of serious adverse events (SAE) and adverse events of special interest (AESI) considered related to study vaccination
Timeframe: 14 Months
Frequency overall and in each dosage group of solicited injection site and systemic reactogenicity.
Timeframe: Day of vaccine administration to day 8 after each vaccination
Frequency overall and in each dosage group of unsolicited vaccine-related adverse events (AE), including vaccine-related laboratory AE.
Timeframe: 28 Days after each vaccination
Severity overall and in each dosage group of solicited injection site and systemic reactogenicity.
Timeframe: Day of vaccine administration to day 8 after each vaccination
Severity overall and in each dosage group of unsolicited vaccine-related adverse events (AE), including vaccine-related laboratory AE.
Timeframe: 28 Days after each vaccination
Type overall and in each dosage group of serious adverse events (SAE) and adverse events of special interest (AESI) considered related to study vaccination
Timeframe: 14 Months