Zika Virus Infection
Conditions
Keywords
Inactivated, Phase I, placebo-controlled, Vaccine, ZIKA
Brief 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.
Interventions
DRUGSaline
Sodium chloride solution.
Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Must be a male or non-pregnant, non-breastfeeding female between the age of 18 and 49 years, inclusive at the time of screening and enrollment 2. Must be willing and able to read, sign and date the informed consent document before study related procedures are performed 3. Must be willing and able to comply with study requirements and available for follow-up visits for the entire study 4. Must have a means to be contacted by telephone 5. Must have a body mass index (BMI) \>/=18.1 and \<35.0 kg/m\^2 6. Must have acceptable\* screening laboratory findings within 28 days before enrollment * Acceptable clinical laboratory parameters include: * Hemoglobin: women: \>11.5 g/dL; men \>12.5 g/d * White blood cell count: \>3,400 cells/mm\^3 but \<11,000 cells/mm\^3 * Platelets: \>139,000 but \<450,000 per mm\^3 * Urine dipstick (clean urine sample): protein \<1+, glucose negative * Serum creatinine \</=1 x institutional upper limit of normal (ULN) * Blood urea nitrogen (BUN) \<25 * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<1.25 x institutional ULN * Total bilirubin \<1.25 x institutional ULN * Note: If laboratory screening tests are out of acceptable range, repeat of screening tests is permitted once, provided there is an alternative explanation for the out of range value 7. Must be in good health based on the investigator's clinical judgment when considering findings from past medical history, medication use, vital signs, and an abbreviated physical examination. Note 1: Good health is defined by the absence of any medical condition described in the
Exclusion criteria
in a subject with a normal abbreviated physical exam and vital signs. If the subject has a preexisting condition not listed in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type overall and in each dosage group of serious adverse events (SAE) and adverse events of special interest (AESI) considered related to study vaccination | 14 Months |
| Frequency overall and in each dosage group of solicited injection site and systemic reactogenicity. | 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. | 28 Days after each vaccination |
| Severity overall and in each dosage group of solicited injection site and systemic reactogenicity. | 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. | 28 Days after each vaccination |
| Comparison between dosage groups of the frequency of vaccine-related Grade 3 local, systemic, or laboratory AE | 8 Days after each vaccination |
| Comparison between dosage groups of the type of vaccine-related Grade 2 or greater local or systemic reactogenicity | 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 | 8 Days after each vaccination |
| Comparison of study withdrawals, and discontinuation of study vaccination due to any reason between dosage groups. | 14 Months |
| Comparison between dosage groups of the duration of vaccine-related Grade 2 or greater local or systemic reactogenicity | 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 | 8 Days after each vaccination |
| Comparison between dosage groups of the frequency of vaccine-related Grade 2 or greater local or systemic reactogenicity | 8 Days after each vaccination |
| Duration overall and in each dosage group of serious adverse events (SAE) and adverse events of special interest (AESI) considered related to study vaccination | 14 Months |
| Frequency of new onset chronic medical conditions | 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 | 14 Months |
Secondary
| Measure | Time frame |
|---|---|
| Per visit GMT overall and by dosage group as measured by ZIKV ELISA and neutralization assay. | At all post-vaccination visits, an average of 14 months |
| Proportion of subjects overall and by dosage group that seroconvert to ZIKV at each post-vaccination visit by assessing ELISA responses in comparison with baseline | At all post-vaccination visits, an average of 14 months |
| Proportion of subjects overall and by dosage group that seroconvert to ZIKV at each post-vaccination visit by assessing neutralization titers in comparison with baseline | At all post-vaccination visits, an average of 14 months |
| Peak GMT overall and by dosage group as measured by ZIKV ELISA and neutralization assay. | At all post-vaccination visits, an average of 14 months |
Countries
United States
Outcome results
None listed