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  1. Article ; Online: Safety and Immunogenicity of Inactivated Whole Virion COVID-19 Vaccine CoviVac in Clinical Trials in 18-60 and 60+ Age Cohorts.

    Gordeychuk, Ilya V / Kozlovskaya, Liubov I / Siniugina, Aleksandra A / Yagovkina, Nadezhda V / Kuzubov, Vladimir I / Zakharov, Konstantin A / Volok, Viktor P / Dodina, Maria S / Gmyl, Larissa V / Korotina, Natalya A / Theodorovich, Rostislav D / Ulitina, Yulia I / Vovk, Dmitry I / Alikova, Marina V / Kataeva, Anna A / Kalenskaya, Anna V / Solovjeva, Irina V / Tivanova, Elena V / Kondrasheva, Larissa Y /
    Ploskireva, Antonina A / Akimkin, Vasiliy G / Subbotina, Ksenia A / Ignatyev, Georgy M / Korduban, Anastasia K / Shustova, Elena Y / Bayurova, Ekaterina O / Zhitkevich, Alla S / Avdoshina, Daria V / Piniaeva, Anastasia N / Kovpak, Anastasia A / Antonova, Liliya P / Rogova, Yulia V / Shishova, Anna A / Ivin, Yury Y / Sotskova, Svetlana E / Chernov, Konstantin A / Ipatova, Elena G / Korduban, Ekaterina A / Ishmukhametov, Aydar A

    Viruses

    2023  Volume 15, Issue 9

    Abstract: We present the results of a randomized, double-blind, placebo-controlled, multi-center clinical trial phase I/II of the tolerability, safety, and immunogenicity of the inactivated whole virion concentrated purified coronavirus vaccine CoviVac in ... ...

    Abstract We present the results of a randomized, double-blind, placebo-controlled, multi-center clinical trial phase I/II of the tolerability, safety, and immunogenicity of the inactivated whole virion concentrated purified coronavirus vaccine CoviVac in volunteers aged 18-60 and open multi-center comparative phase IIb clinical trial in volunteers aged 60 years and older. The safety of the vaccine was assessed in 400 volunteers in the 18-60 age cohort who received two doses of the vaccine (n = 300) or placebo (n = 100) and in 200 volunteers in 60+ age cohort all of whom received three doses of the vaccine. The studied vaccine has shown good tolerability and safety. No deaths, serious adverse events (AEs), or other significant AEs related to vaccination have been detected. The most common AE in vaccinated participants was pain at the injection site (
    MeSH term(s) Humans ; Middle Aged ; Aged ; COVID-19 Vaccines/adverse effects ; COVID-19/prevention & control ; Vaccines, Attenuated ; Antibodies, Neutralizing ; Antibodies, Viral
    Chemical Substances COVI-VAC ; COVID-19 Vaccines ; Vaccines, Attenuated ; Antibodies, Neutralizing ; Antibodies, Viral
    Language English
    Publishing date 2023-08-29
    Publishing country Switzerland
    Document type Randomized Controlled Trial ; Multicenter Study ; Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2516098-9
    ISSN 1999-4915 ; 1999-4915
    ISSN (online) 1999-4915
    ISSN 1999-4915
    DOI 10.3390/v15091828
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Long-term humoral immunogenicity, safety and protective efficacy of inactivated vaccine against COVID-19 (CoviVac) in preclinical studies.

    Kozlovskaya, Liubov I / Piniaeva, Anastasia N / Ignatyev, Georgy M / Gordeychuk, Ilya V / Volok, Viktor P / Rogova, Yulia V / Shishova, Anna A / Kovpak, Anastasia A / Ivin, Yury Yu / Antonova, Liliya P / Mefyod, Kirill M / Prokosheva, Lyubov S / Sibirkina, Anna S / Tarasova, Yuliya Yu / Bayurova, Ekaterina O / Gancharova, Olga S / Illarionova, Victoria V / Glukhov, Grigory S / Sokolova, Olga S /
    Shaitan, Konstantin V / Moysenovich, Anastasia M / Gulyaev, Stanislav A / Gulyaeva, Tatiana V / Moroz, Andrey V / Gmyl, Larissa V / Ipatova, Elena G / Kirpichnikov, Mikhail P / Egorov, Alexey M / Siniugina, Aleksandra A / Ishmukhametov, Aydar A

    Emerging microbes & infections

    2021  Volume 10, Issue 1, Page(s) 1790–1806

    Abstract: The unprecedented in recent history global COVID-19 pandemic urged the implementation of all existing vaccine platforms to ensure the availability of the vaccines against COVID-19 to every country in the world. Despite the multitude of high-quality ... ...

    Abstract The unprecedented in recent history global COVID-19 pandemic urged the implementation of all existing vaccine platforms to ensure the availability of the vaccines against COVID-19 to every country in the world. Despite the multitude of high-quality papers describing clinical trials of different vaccine products, basic detailed data on general toxicity, reproductive toxicity, immunogenicity, protective efficacy and durability of immune response in animal models are scarce. Here, we developed a β-propiolactone-inactivated whole virion vaccine CoviVac and assessed its safety, protective efficacy, immunogenicity and stability of the immune response in rodents and non-human primates. The vaccine showed no signs of acute/chronic, reproductive, embryo- and fetotoxicity, or teratogenic effects, as well as no allergenic properties in studied animal species. The vaccine induced stable and robust humoral immune response both in form of specific anti-SARS-CoV-2 IgG and NAbs in mice, Syrian hamsters, and common marmosets. The NAb levels did not decrease significantly over the course of one year. The course of two immunizations protected Syrian hamsters from severe pneumonia upon intranasal challenge with the live virus. Robustness of the vaccine manufacturing process was demonstrated as well. These data encouraged further evaluation of CoviVac in clinical trials.
    MeSH term(s) Animals ; Antibodies, Neutralizing/immunology ; Antibodies, Viral/immunology ; COVID-19/immunology ; COVID-19/prevention & control ; COVID-19/virology ; COVID-19 Vaccines/administration & dosage ; COVID-19 Vaccines/adverse effects ; COVID-19 Vaccines/immunology ; Callithrix ; Cricetinae ; Disease Models, Animal ; Drug Evaluation, Preclinical ; Female ; Guinea Pigs ; Humans ; Immunity, Humoral ; Immunogenicity, Vaccine ; Immunoglobulin G/immunology ; Male ; Mesocricetus ; Mice ; Mice, Inbred BALB C ; Rats ; Rats, Wistar ; SARS-CoV-2/genetics ; SARS-CoV-2/immunology ; Time Factors ; Vaccines, Inactivated/administration & dosage ; Vaccines, Inactivated/adverse effects ; Vaccines, Inactivated/immunology
    Chemical Substances Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines ; Immunoglobulin G ; Vaccines, Inactivated
    Language English
    Publishing date 2021-08-24
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2681359-2
    ISSN 2222-1751 ; 2222-1751
    ISSN (online) 2222-1751
    ISSN 2222-1751
    DOI 10.1080/22221751.2021.1971569
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Safety and immunogenicity of inactivated whole virion vaccine CoviVac against COVID-19: a multicenter, randomized, double-blind, placebo-controlled phase I/II clinical trial

    Ishmukhametov, Aydar A / Siniugina, Aleksandra A / Yagovkina, Nadezhda V / Kuzubov, Vladimir I / Zakharov, Konstantin A / Volok, Viktor P / Dodina, Maria S / Gmyl, Larissa V / Korotina, Natalya A / Theodorovich, Rostislav D / Ulitina, Yulia I / Tsaan, Andrey A / Pomaskina, Tatiana V / Kalenskaya, Anna V / Solovjeva, Irina V / Tivanova, Elena V / Kondrasheva, Larissa Y / Ploskireva, Antonina A / Akimkin, Vasiliy G /
    Subbotina, Ksenia A / Ignatyev, Georgy M / Korduban, Anastasia K / Shustova, Elena Y / Bayurova, Ekaterina O / Kondrashova, Alla S / Avdoshina, Darya V / Piniaeva, Anastasia N / Kovpak, Anastasia A / Antonova, Liliya P / Rogova, Yulia V / Shishova, Anna A / Ivin, Yury Y / Sotskova, Svetlana E / Chernov, Konstantin A / Ipatova, Elena G / Korduban, Ekaterina A / Kozlovskaya, Liubov I / Gordeychuk, Ilya V

    medRxiv

    Abstract: We present the results of a randomized, double-blind, placebo-controlled, multi-center clinical trial of the tolerability, safety, and immunogenicity of the inactivated whole virion concentrated purified coronavirus vaccine CoviVac in adult volunteers ... ...

    Abstract We present the results of a randomized, double-blind, placebo-controlled, multi-center clinical trial of the tolerability, safety, and immunogenicity of the inactivated whole virion concentrated purified coronavirus vaccine CoviVac in adult volunteers aged 18-60. Safety of the vaccine was assessed in 398 volunteers who received two doses of the vaccine (n=298) or placebo (n=100). The studied vaccine has shown good tolerability and safety. No deaths, serious adverse events (AE), or other significant AE related to vaccination have been detected. The most common AE in vaccinated participants was pain at the injection site (p<0.05). Immunogenicity assessment was performed in 167 volunteers (122 vaccinated and 45 in Placebo Group) separately for the participants who were anti-SARS-CoV-2 nAB negative (69/122 in Vaccine Group and 28/45 in Placebo Group) or positive (53/122 in Vaccine Group and 17/45 in Placebo Group) at screening. At Day 42 after the first immunization the seroconversion rate in participants who were seronegative at screening was 86.9% with average the geometric mean neutralizing antibody (nAB) titer of 1:20. Statistically significant (p<0.05) increase of IFN-γ production by peptide-stimulated T-cells was observed at Days 14 and 21 after the first immunization. In participants who were seropositive at screening but had nAB titers below 1:256 the rate of 4-fold increase in nAB levels was 85.2%, while in the participants with nAB titers >1:256 the rate of 4-fold increase in nAB levels was below 45%. For the participants who were seropositive at screening the second immunization did not lead to a significant increase in nAB titers. In conclusion, inactivated vaccine CoviVac has shown good tolerability and safety, with 86.9% seroconversion rates in participants, who were seronegative at screening. In participants who were seropositive at screening and had nAB titers below 1:256, a single immunization lead to a 4-fold increase in nAB levels in 85.2% cases.
    Keywords covid19
    Language English
    Publishing date 2022-02-09
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2022.02.08.22270658
    Database COVID19

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