Interim report of preclinical trials (PCTs) was received
Preclinical development took almost a year.
According to the results of the PCTs:
the immunogenicity, safety, protectivity (protective potential) of the vaccine were confirmed
mechanisms of generation of cellular immunity were revealed
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:
increase in titers of specific antibodies against N protein
proliferation of specific T cells
antibody-dependent cytotoxicity
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 began
February 2024
The phase III of clinical trials of Convacell® was completed
The study involved 5,229 volunteers, 3,486 in the vaccine group and 1,743 in the placebo group.
Most volunteers were vaccinated in the summer of 2023. During 180 days of follow-up, 8 cases of COVID-19 (0.23% during 180 days of follow-up) were detected in the vaccine group by PCR test, while in the placebo group 27 cases (1.55% during 180 days of follow-up) were detected. The vaccine showed 83.3% efficacy against COVID-19 infection. In the population of volunteers aged over 60, the efficacy was 91.7%.
May 2024
The Ministry of Health of the Russian Federation issued a permanent marketing authorization for Convacell® vaccine.
