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

Summary

The aim of the clinical study is to study the safety and tolerability of the live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus, in intracutaneous administration.

The research tasks are to:

* evaluate the safety of various schemes for the use of the VAC∆6 vaccine using a set of clinical and laboratory-instrumental methods (thermometry, blood pressure registration, auscultation of the heart and lungs, electrocardiography (ECG), complete blood count and common urine test, biochemical, immunological, and virological studies);
* evaluate the reactogenicity of various schemes for the use of the VAC∆6 vaccine (taking into account the number of local and systemic reactions, the percentage of those vaccinated with various degrees of manifestation of systemic and local reactions);
* evaluate the possibility of virus shedding into the environment by volunteers;
* evaluate the immunological efficacy of various vaccine administration schemes;
* identify the development of undesirable reactions to the administration of the vaccine;
* evaluate the cellular immune response to the introduction of various schemes for the use of the vaccine;
* evaluate preliminary efficacy data in order to select an optimal scheme for the administration of the vaccine to make a decision on conducting Phase II clinical trials in an extended group of volunteers.

Conditions

• Smallpox
• Monkeypox
• Cowpox
• Vaccinia 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®.

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)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-05-18

Primary Completion

2019-07-22

Completion

2020-01-27

Countries

• Russia

Study Locations