334
Participants
Start Date
October 1, 2021
Primary Completion Date
December 31, 2021
Study Completion Date
April 1, 2022
VAC∆6 vaccine (10⁷ PFU)
"Live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus (manufactured by FBRI SRC VB Vector, Rospotrebnadzor).~Batch: 08-10.19 (expiry date: 13.10.2021). Dosage: single intradermal dose of 10⁷ PFU/0.2 ml of vaccinia virus."
VAC∆6 vaccine (10⁶ PFU)
"Live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus (manufactured by FBRI SRC VB Vector, Rospotrebnadzor).~Batch: 08-10.19 (expiry date: 13.10.2021). Dosage: two intradermal doses of 10⁶ PFU/0.2 ml of vaccinia virus (given 28 days apart)."
Live Smallpox Vaccine
"Live smallpox vaccine (Smallpox vaccine) (manufactured by the Federal State Unitary Enterprise NPO Microgen of the Ministry of Health of Russia).~Batch No. Т30 (expiry date: March, 2021). Dosage: Single 1x10⁶ PFU dose administered by multiple-pricking technique on the 30th/60th day after full series of vaccination with VAC∆6."
Placebo (Sodium chloride bufus, 0.9%)
"Sodium chloride bufus, a 0.9% solvent for the preparation of a dosage form for injections (manufactured by JSC Pharmaceutical manufacturing company Obnovlenie, Russia).~Batch: 391219 (expiry date: January, 2025)."
"State Budgetary Health Institution of the Novosibirsk Region Municipal Infectious Disease Clinical Hospital No. 1", Novosibirsk
"Federal State Budgetary Institution of Healthcare Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency (FGBUZ MSCH-163, FMBA of Russia)", Kol'tsovo
"Federal Budgetary Research Institution State Research Center of Virology and Biotechnology Vector"
OTHER_GOV