Prevention of Zika virus infection
Conditions
Interventions
investigational material(s)
Generic name etc : KD-406
INN of investigational material : -
Therapeutic category code : 631 Vaccines
Dosage and Administration for Investigational material : [Group 1] In
Sponsors
KM Biologics Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adult males and females aged >=20 years to <65 years (from the time of informed consent to the third administration of investigational product). 2) Those who are judged to be healthy adults qualified to participate in this clinical study by the principal investigator or sub-investigator as a result of the screening exam. 3) Those who have given written informed consent.
Exclusion criteria
Exclusion criteria: 1) Those who had Zika virus infection, dengue virus infection, Japanese encephalitis, tick-borne encephalitis, or yellow fever (based on interview with subjects). 2) Those who had vaccination history of dengue vaccine, tick-borne encephalitis vaccine, or yellow fever vaccine (based on interview with subjects). 3) Those who have an obvious history of anaphylaxis caused by the components of the investigational products. 4) Pregnant women, women who may be pregnant, women who wish to become pregnant during the clinical trial period, women who are nursing 5) Those who have Fibrodysplasia Ossificans Progressiva (FOP). 6) Those who are determined not to be suitable as a subject of the clinical study by the principle investigator or sub-investigator for any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy [Group1] 1) Incidence and causal relationship to investigational product for all adverse events, death from adverse events, serious adverse events other than death, important adverse events, and severe (Grade 3) adverse events occurring after the first investigational product administration until the follow-up examination for each treatment group. 2) Seroconversion rate against Zika virus after the second investigational product administration for each treatment group. [Group2] 1) Incidence and causal relationship to investigational product for all adverse events, death from adverse events, serious adverse events other than death, important adverse events, and severe (Grade 3) adverse events occurring after the first investigational product administration until the follow-up examination for each treatment group. 2) Seroconversion rate against Zika virus after the third investigational product administration for each treatment group. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy [Group1] 1) The geometric mean titers of neutralizing antibody against Zika virus after the second investigational product administration for each treatment group. 2) Seroconversion rate and the geometric mean titers of neutralizing antibody against Zika virus after the first investigational product administration for each treatment group. 3) Summary statistics value of neutralizing antibody titer against Zika virus at each point of measurement for each treatment group. 4) Transition of neutralizing antibody titer against Zika virus for individual subjects in each treatment group. [Group2] 1) The geometric mean titers of neutralizing antibody against Zika virus after the third investigational product administration for each treatment group. 2) Seroconversion rate and the geometric mean titers of neutralizing antibody against Zika virus after the first and second investigational product administration for each treatment group. 3) Summary statistics value of neutralizing antibody titer against Zika virus at each point of measurement for each treatment group. 4) Transition of neutralizing antibody titer against Zika virus for individual subjects in each treatment group. 5) Differences of seroconversion rate of neutralizing antibody, ratio of the geometric mean titers of neutralizing antibody and the geometric mean ratio against Zika virus after the second and third investigational product administration for each treatment group. | — |
Countries
Japan
Outcome results
None listed