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  1. Article ; Online: Vaccination With Oral Polio Vaccine Reduces COVID-19 Incidence.

    Yagovkina, Nadezhda V / Zheleznov, Lev M / Subbotina, Ksenia A / Tsaan, Andrey A / Kozlovskaya, Liubov I / Gordeychuk, Ilya V / Korduban, Anastasia K / Ivin, Yury Y / Kovpak, Anastasia A / Piniaeva, Anastasia N / Shishova, Anna A / Shustova, Elena Y / Khapchaev, Yusuf K / Karganova, Galina G / Siniugina, Alexandra A / Pomaskina, Tatiana V / Erovichenkov, Aleksandr A / Chumakov, Konstantin / Ishmukhametov, Aydar A

    Frontiers in immunology

    2022  Volume 13, Page(s) 907341

    Abstract: Background: Effective response to emerging pandemic threats is complicated by the need to develop specific vaccines and other medical products. The availability of broadly specific countermeasures that could be deployed early in the pandemic could ... ...

    Abstract Background: Effective response to emerging pandemic threats is complicated by the need to develop specific vaccines and other medical products. The availability of broadly specific countermeasures that could be deployed early in the pandemic could significantly alter its course and save countless lives. Live attenuated vaccines (LAVs) were shown to induce non-specific protection against a broad spectrum of off-target pathogens by stimulating innate immune responses. The purpose of this study was to evaluate the effect of immunization with bivalent Oral Poliovirus Vaccine (bOPV) on the incidence of COVID-19 and other acute respiratory infections (ARIs).
    Methods and findings: A randomized parallel-group comparative study was conducted in Kirov Medical University. 1115 healthy volunteers aged 18 to 65 were randomized into two equal groups, one of which was immunized orally with a single dose of bOPV "BiVac Polio" and another with placebo. The study participants were monitored for three months for respiratory illnesses including COVID-19. The endpoint was the incidence of acute respiratory infections and laboratory confirmed COVID-19 in both groups during 3 months after immunization. The number of laboratory-confirmed cases of COVID-19 was significantly lower in the vaccinated group than in placebo (25 cases vs. 44, p=0.036). The difference between the overall number of clinically diagnosed respiratory illnesses in the two groups was not statistically significant.
    Conclusions: Immunization with bOPV reduced the number of laboratory-confirmed COVID-19 cases, consistent with the original hypothesis that LAVs induce non-specific protection against off-target infections. The findings are in line with previous observations of the protective effects of OPV against seasonal influenza and other viral and bacterial pathogens. The absence of a statistically significant effect on the total number of ARIs may be due to the insufficient number of participants and heterogeneous etiology of ARIs. OPV could be used to complement specific coronavirus vaccines, especially in regions of the world where the vaccines are unavailable, and as a stopgap measure for urgent response to future emerging infections. Clinical trial registration number NCT05083039 at clinicaltrals.gov https://clinicaltrials.gov/ct2/show/NCT05083039?term=NCT05083039&draw=2&rank=1.
    MeSH term(s) COVID-19/epidemiology ; COVID-19/prevention & control ; Humans ; Incidence ; Poliomyelitis/epidemiology ; Poliomyelitis/prevention & control ; Poliovirus Vaccine, Oral ; Respiratory Tract Infections ; Vaccination/methods
    Chemical Substances Poliovirus Vaccine, Oral
    Language English
    Publishing date 2022-05-30
    Publishing country Switzerland
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2606827-8
    ISSN 1664-3224 ; 1664-3224
    ISSN (online) 1664-3224
    ISSN 1664-3224
    DOI 10.3389/fimmu.2022.907341
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. 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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  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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