Sky Zoster is a live-attenuated zoster vaccine developed and tested in Korea
This vaccine is indicated for adults over the age of 50 to prevent Shingles (Herpes Zoster).
Sky Zoster is administered as a single dose by subcutaneous injection into the outer aspect of the upper arm.
May 20, 2019, the study's results found ‘no statistically significant difference between the 2 groups in terms of the geometric mean spot numbers determined by IFN-γ and IL-2 ELISPOT assays at 6 weeks post vaccination.’
Clinical Trial NCT03120364: Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
- This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme-Linked Immunosorbent Assay). Total of 824 healthy subjects (412 subjects per treatment arm) aged 50 and over are enrolled, and each subject is administered with a single dose of vaccine which is randomly assigned.
- This is a multi-center, randomized, double-blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to Zostavax which are indicated for the prevention of herpes zoster. Total of 824 healthy subjects aged 50 and over are enrolled, and each subject is administered with a single dose of vaccine which is randomly assigned in 1:1 ratio. Stratified randomization for the age group is used to achieve the balance of treatment assignment within age strata.
- Total of five visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 2 and Visit 4 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 3*, Visit 4 and Visit 5* (* telephone contact)