Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years

Summary

The Aim:

Study immunogenicity, confirm the safety and tolerability of different schedules of vaccination with "live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus" using a complex of clinical and laboratory-instrumental techniques.

The research tasks are to:

1. To study the immunological activity of a single VAC∆6 vaccine dose of 1x10⁷ plaque-forming units (PFU).
2. To study the immunological activity of two VAC∆6 vaccine doses (given 28 days apart) of 1x10⁶ PFU.
3. Assess the safety of different VAC∆6 vaccination schedules using a set of clinical and laboratory-instrumental techniques (thermometry, measurement of blood pressure, heart and lung auscultation, ECG, common blood and urine tests, biochemical, immunological and virological studies).
4. Assess the reactogenicity of different VAC∆6 vaccination schedules (number of local and systemic reactions, the percentage of those vaccinated with systemic and local reactions of various severity degrees).
5. To identify VAC∆6 vaccine-associated adverse events.
6. Study cell-mediated immunity induced by different VAC∆6 vaccination schedules.
7. Determine the presence of the virus in specific skin formations (crusts, pustules), saliva, blood and urine.
8. Evaluate the protective efficacy of one and two doses of the studied VAC∆6 vaccine.

Conditions

• Smallpox
• Monkeypox
• Cowpox
• Vaccinia Virus Infection

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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).

BIOLOGICAL

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.

OTHER

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).

Sponsors & Collaborators

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

  lead OTHER_GOV

Principal Investigators

• Vladimir I. Kuzubov, PhD · Medical and Sanitary Unit No. 163 (FGBUZ MSCH-163, FMBA Russia) (Novosibirsk)

• Irina V Krasil'nikova, PhD · Municipal Infectious Disease Clinical Hospital No. 1 (Novosibirsk)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-01

Primary Completion

2021-12-31

Completion

2022-04-01

Countries

• Russia

Study Locations