Clinical trials

Marketing Authorization of pharmaceutical product for human use

June 2021
Interim report of preclinical trials (PCTs) was received

Preclinical development took almost a year.
According to the results of the PCTs:

It was shown that:
these activated immune cells really prevented the damage to organs, primarily the bronchopulmonary system, and actually protected the lung tissue in animals, which was very important.

As part of the PCTs, a number of experiments was carried out on various small animals: mice, rabbits, golden hamsters for protective properties of activated cells of the immune system.

July 2021
Permission to conduct Phases I and II clinical trials (CTs) was obtained.

Combined Phase I-II clinical trials of Convacell® began on July 19, 2021 and involved about 200 people aged 18 to 60 years.

The clinical trial showed that vaccination with Convacell® induced a stable immunity in humans, which prevented the development of coronavirus infection. It also facilitates:

None of the volunteers who received the vaccine fell ill with COVID-19 during the entire observation period
October 2022
The approval of Phase IIb/III clinical trial of Convacell® was obtained
“Subject to the results of the Phase IIb clinical trial, it is planned to expand the indications for use (persons over 60 years old) and switch to a single immunization. After that, Phase III will begin involving about 17,000 volunteers to confirm the preventive efficiency of Convacell®.”

HEAD OF TRIALS AND REGISTRATION DEPARTMENT OF SPbSRIVS
ELLINA RUZANOVA

December 2022
The Phase 2b clinical trial of Convacell® vaccine is finished
“According to the completed phase 2b of the trial the following changes have been introduced:
- extended therapeutic indications (it is possible to vaccinate people aged 18 and over, with no upper age limit)
- changed dosage scheme to a single
- the shelf life of the product has been extended from 6 months to 1 year”

HEAD OF TRIALS AND REGISTRATION DEPARTMENT OF SPbSRIVS
ELLINA RUZANOVA

March 2023
Phase III clinical trials of the Convacell® vaccine have begun