tetano
Editor, Senior Moderator
EClinicalMedicine
. 2022 Jun 25;50:101526.
doi: 10.1016/j.eclinm.2022.101526. eCollection 2022 Aug.
Efficacy and safety of an inactivated whole-virion vaccine against COVID-19, QazCovid-in®, in healthy adults: A multicentre, randomised, single-blind, placebo-controlled phase 3 clinical trial with a 6-month follow-up
Berik Khairullin[SUP] 1 [/SUP], Kunsulu Zakarya[SUP] 1 [/SUP], Mukhit Orynbayev[SUP] 1 [/SUP], Yergali Abduraimov[SUP] 1 [/SUP], Markhabat Kassenov[SUP] 1 [/SUP], Gulbanu Sarsenbayeva[SUP] 1 [/SUP], Kulyaisan Sultankulova[SUP] 1 [/SUP], Olga Chervyakova[SUP] 1 [/SUP], Balzhan Myrzakhmetova[SUP] 1 [/SUP], Aziz Nakhanov[SUP] 1 [/SUP], Ainur Nurpeisova[SUP] 1 [/SUP], Kuandyk Zhugunissov[SUP] 1 [/SUP], Nurika Assanzhanova[SUP] 1 [/SUP], Sergazy Nurabayev[SUP] 1 [/SUP], Aslan Kerimbayev[SUP] 1 [/SUP], Zakir Yershebulov[SUP] 1 [/SUP], Yerbol Burashev[SUP] 1 [/SUP], Ilyas Kulmagambetov[SUP] 2 [/SUP], Timur Davlyatshin[SUP] 3 [/SUP], Maria Sergeeva[SUP] 4 [/SUP], Zhanna Buzitskaya[SUP] 4 [/SUP], Marina Stukova[SUP] 4 [/SUP], Lespek Kutumbetov[SUP] 1 [/SUP]
Affiliations
Abstract
Background: Vaccination remains the primary measure to prevent the spread of the SARS-CoV-2 virus, further necessitating the use of effective licensed vaccines.
Methods: From Dec 25, 2020, to July 11, 2021, we conducted a multicenter, randomised, single-blind, placebo-controlled phase 3 efficacy trial of the QazCovid-in® vaccine with a 180-day follow-up period in three clinical centres in Kazakhstan. A total of 3000 eligible participants aged 18 years or older were randomly assigned (4:1) to receive two doses of the vaccine (5 μg each, 21 days apart) or placebo administered intramuscularly. QazCovid-in® is a whole-virion formaldehyde-inactivated anti-COVID-19 vaccine, adjuvanted with aluminium hydroxide. The primary endpoint was the incidence of symptomatic cases of the SARS-CoV-2 infection confirmed by RT-PCR starting from day 14 after the first immunisation. The trial was registered with ClinicalTrials.gov NCT04691908.
Findings: The QazCovid-in® vaccine was safe over the 6-month monitoring period after two intramuscular immunisations inducing only local short-lived adverse events. The concomitant diseases of participants did not affect the vaccine safety. Out of 2400 vaccinated participants, 31 were diagnosed with COVID-19; 43 COVID-19 cases were recorded in 600 placebo participants with onset of 14 days after the first dose within the 180-day observation period. Only one severe COVID-19 case was identified in a vaccine recipient with a comorbid chronic heart failure. The protective efficacy of the QazCovid-in® vaccine reached 82·0% (95% CI 71.1-88.5) within the 180-day observation period.
Interpretation: Two immunisations with the inactivated QazCovid-in® vaccine achieved 82·0% (95% CI 71.1-88.5) protective efficacy against COVID-19 within a 180-day follow-up period.
Funding: The work was funded by the Science Committee of the Ministry of Education and Science of Kazakhstan within the framework of the Scientific and Technical Program "Development of a vaccine against coronavirus infection COVID-19". State registration number 0.0927.
Keywords: COVID-19; Clinical trial; Efficacy; Phase 3; Vaccine; Virus.
. 2022 Jun 25;50:101526.
doi: 10.1016/j.eclinm.2022.101526. eCollection 2022 Aug.
Efficacy and safety of an inactivated whole-virion vaccine against COVID-19, QazCovid-in®, in healthy adults: A multicentre, randomised, single-blind, placebo-controlled phase 3 clinical trial with a 6-month follow-up
Berik Khairullin[SUP] 1 [/SUP], Kunsulu Zakarya[SUP] 1 [/SUP], Mukhit Orynbayev[SUP] 1 [/SUP], Yergali Abduraimov[SUP] 1 [/SUP], Markhabat Kassenov[SUP] 1 [/SUP], Gulbanu Sarsenbayeva[SUP] 1 [/SUP], Kulyaisan Sultankulova[SUP] 1 [/SUP], Olga Chervyakova[SUP] 1 [/SUP], Balzhan Myrzakhmetova[SUP] 1 [/SUP], Aziz Nakhanov[SUP] 1 [/SUP], Ainur Nurpeisova[SUP] 1 [/SUP], Kuandyk Zhugunissov[SUP] 1 [/SUP], Nurika Assanzhanova[SUP] 1 [/SUP], Sergazy Nurabayev[SUP] 1 [/SUP], Aslan Kerimbayev[SUP] 1 [/SUP], Zakir Yershebulov[SUP] 1 [/SUP], Yerbol Burashev[SUP] 1 [/SUP], Ilyas Kulmagambetov[SUP] 2 [/SUP], Timur Davlyatshin[SUP] 3 [/SUP], Maria Sergeeva[SUP] 4 [/SUP], Zhanna Buzitskaya[SUP] 4 [/SUP], Marina Stukova[SUP] 4 [/SUP], Lespek Kutumbetov[SUP] 1 [/SUP]
Affiliations
- PMID: 35770251
- PMCID: PMC9233449
- DOI: 10.1016/j.eclinm.2022.101526
Abstract
Background: Vaccination remains the primary measure to prevent the spread of the SARS-CoV-2 virus, further necessitating the use of effective licensed vaccines.
Methods: From Dec 25, 2020, to July 11, 2021, we conducted a multicenter, randomised, single-blind, placebo-controlled phase 3 efficacy trial of the QazCovid-in® vaccine with a 180-day follow-up period in three clinical centres in Kazakhstan. A total of 3000 eligible participants aged 18 years or older were randomly assigned (4:1) to receive two doses of the vaccine (5 μg each, 21 days apart) or placebo administered intramuscularly. QazCovid-in® is a whole-virion formaldehyde-inactivated anti-COVID-19 vaccine, adjuvanted with aluminium hydroxide. The primary endpoint was the incidence of symptomatic cases of the SARS-CoV-2 infection confirmed by RT-PCR starting from day 14 after the first immunisation. The trial was registered with ClinicalTrials.gov NCT04691908.
Findings: The QazCovid-in® vaccine was safe over the 6-month monitoring period after two intramuscular immunisations inducing only local short-lived adverse events. The concomitant diseases of participants did not affect the vaccine safety. Out of 2400 vaccinated participants, 31 were diagnosed with COVID-19; 43 COVID-19 cases were recorded in 600 placebo participants with onset of 14 days after the first dose within the 180-day observation period. Only one severe COVID-19 case was identified in a vaccine recipient with a comorbid chronic heart failure. The protective efficacy of the QazCovid-in® vaccine reached 82·0% (95% CI 71.1-88.5) within the 180-day observation period.
Interpretation: Two immunisations with the inactivated QazCovid-in® vaccine achieved 82·0% (95% CI 71.1-88.5) protective efficacy against COVID-19 within a 180-day follow-up period.
Funding: The work was funded by the Science Committee of the Ministry of Education and Science of Kazakhstan within the framework of the Scientific and Technical Program "Development of a vaccine against coronavirus infection COVID-19". State registration number 0.0927.
Keywords: COVID-19; Clinical trial; Efficacy; Phase 3; Vaccine; Virus.