Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 18, 2019

Primary Completion Date

July 22, 2019

Study Completion Date

January 27, 2020

Conditions
SmallpoxMonkeypoxCowpoxVaccinia Virus Infection
Interventions
BIOLOGICAL

VAC∆6 vaccine - оnce at a dose of 10⁶ PFU

15 volunteers vaccinated once intradermally at a dose of 10⁶ PFU (0.2 ml) of the VAC∆6 vaccine in the outer surface of the shoulder 8-10 cm below the shoulder joint

BIOLOGICAL

VAC∆6 vaccine - once at a dose of 10⁷ PFU

15 volunteers vaccinated once intradermally at a dose of 10⁷ PFU (0.2 ml) of the VAC∆6 vaccine in the outer surface of the shoulder 8-10 cm below the shoulder joint

BIOLOGICAL

VAC∆6 vaccine - twice at a dose of 10⁶ PFU

15 volunteers vaccinated twice spaced 28 days apart, intradermally at a dose of 10⁶ PFU (0.2 ml) of the VAC∆6 vaccine in the outer surface of the shoulder 8-10 cm below the shoulder joint

BIOLOGICAL

Live smallpox vaccine (Smallpox vaccine) + The OspaVir® inactivated smallpox vaccine

15 volunteers vaccinated by the two-step vaccination method: Step 1 - the first vaccination once subcutaneously with 1 dose (0.5 ml) of the inactivated smallpox vaccine OspaVir® in the area of the left shoulder 8-10 cm below the shoulder joint; Step 2 - the second vaccination once by the method of multiple puncture into the outer surface of the shoulder 8-10 cm below the shoulder joint with a live smallpox vaccine at a dose of 1x 106 PFU 7 days following the first vaccination with OspaVir®.

Trial Locations (1)

630559

Federal State Budgetary Healthcare Institution - Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency (FGBUZ MSCH-163, FMBA Russia), Novosibirsk

All Listed Sponsors
lead

"Federal Budgetary Research Institution State Research Center of Virology and Biotechnology Vector"

OTHER_GOV

NCT05762523 - Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years | Biotech Hunter | Biotech Hunter