PMID- 37766235
OWN - NLM
STAT- MEDLINE
DCOM- 20231004
LR  - 20231006
IS  - 1999-4915 (Electronic)
IS  - 1999-4915 (Linking)
VI  - 15
IP  - 9
DP  - 2023 Aug 29
TI  - Safety and Immunogenicity of Inactivated Whole Virion COVID-19 Vaccine CoviVac in 
      Clinical Trials in 18-60 and 60+ Age Cohorts.
LID - 10.3390/v15091828 [doi]
LID - 1828
AB  - 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 (p < 0.05). 
      Immunogenicity assessment in stage 3 of Phase II was performed on 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. On 
      Day 42 after the 1st vaccination, the seroconversion rate in participants who 
      were seronegative at screening was 86.9%, with the average geometric mean 
      neutralizing antibody (nAB) titer of 1:20. A statistically significant (p < 0.05) 
      increase in IFN-gamma production by peptide-stimulated T-cells was observed at Days 
      14 and 21 after the 1st vaccination. In participants who were seropositive at 
      screening but had nAB titers below 1:256, the rate of fourfold increase in nAB 
      levels was 85.2%, while in the participants with nAB titers > 1:256, the rate of 
      fourfold increase in nAB levels was below 45%; the participants who were 
      seropositive at screening of the 2nd vaccination did not lead to a significant 
      increase in nAB titers. In conclusion, inactivated vaccine CoviVac has shown good 
      tolerability and safety, with over 85% NT seroconversion rates after complete 
      vaccination course in participants who were seronegative at screening in both age 
      groups: 18-60 and 60+. In participants who were seropositive at screening and had 
      nAB titers below 1:256, a single vaccination led to a fourfold increase in nAB 
      levels in 85.2% of cases. These findings indicate that CoviVac can be 
      successfully used both for primary vaccination in a two-dose regimen and for 
      booster vaccination as a single dose in individuals with reduced neutralizing 
      antibody levels.
FAU - Gordeychuk, Ilya V
AU  - Gordeychuk IV
AUID- ORCID: 0000-0002-4551-7535
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
AD  - Institute for Translational Medicine and Biotechnology, Sechenov First Moscow 
      State Medical University, 117418 Moscow, Russia.
FAU - Kozlovskaya, Liubov I
AU  - Kozlovskaya LI
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
AD  - Institute for Translational Medicine and Biotechnology, Sechenov First Moscow 
      State Medical University, 117418 Moscow, Russia.
FAU - Siniugina, Aleksandra A
AU  - Siniugina AA
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Yagovkina, Nadezhda V
AU  - Yagovkina NV
AD  - Kirov State Medical University of the Ministry of Health of Russia, 610998 Kirov, 
      Russia.
FAU - Kuzubov, Vladimir I
AU  - Kuzubov VI
AD  - Healthcare Unit No. 163 of Federal Medical Biological Agency of Russia, 630559 
      Novosibirsk Region, Russia.
FAU - Zakharov, Konstantin A
AU  - Zakharov KA
AUID- ORCID: 0000-0002-0557-0382
AD  - Eco-Safety Scientific Research Center, 196143 Saint-Petersburg, Russia.
FAU - Volok, Viktor P
AU  - Volok VP
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
AD  - Lomonosov Moscow State University, 119991 Moscow, Russia.
FAU - Dodina, Maria S
AU  - Dodina MS
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Gmyl, Larissa V
AU  - Gmyl LV
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Korotina, Natalya A
AU  - Korotina NA
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Theodorovich, Rostislav D
AU  - Theodorovich RD
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Ulitina, Yulia I
AU  - Ulitina YI
AD  - RIC-Pharma, 123298 Moscow, Russia.
FAU - Vovk, Dmitry I
AU  - Vovk DI
AD  - RIC-Pharma, 123298 Moscow, Russia.
FAU - Alikova, Marina V
AU  - Alikova MV
AD  - RIC-Pharma, 123298 Moscow, Russia.
FAU - Kataeva, Anna A
AU  - Kataeva AA
AD  - RIC-Pharma, 123298 Moscow, Russia.
FAU - Kalenskaya, Anna V
AU  - Kalenskaya AV
AD  - Central Research Institute of Epidemiology of the Federal Service for 
      Surveillance on Consumer Rights Protection and Human Wellbeing, 111123 Moscow, 
      Russia.
FAU - Solovjeva, Irina V
AU  - Solovjeva IV
AD  - Central Research Institute of Epidemiology of the Federal Service for 
      Surveillance on Consumer Rights Protection and Human Wellbeing, 111123 Moscow, 
      Russia.
FAU - Tivanova, Elena V
AU  - Tivanova EV
AD  - Central Research Institute of Epidemiology of the Federal Service for 
      Surveillance on Consumer Rights Protection and Human Wellbeing, 111123 Moscow, 
      Russia.
FAU - Kondrasheva, Larissa Y
AU  - Kondrasheva LY
AD  - Central Research Institute of Epidemiology of the Federal Service for 
      Surveillance on Consumer Rights Protection and Human Wellbeing, 111123 Moscow, 
      Russia.
FAU - Ploskireva, Antonina A
AU  - Ploskireva AA
AD  - Central Research Institute of Epidemiology of the Federal Service for 
      Surveillance on Consumer Rights Protection and Human Wellbeing, 111123 Moscow, 
      Russia.
FAU - Akimkin, Vasiliy G
AU  - Akimkin VG
AUID- ORCID: 0000-0003-4228-9044
AD  - Central Research Institute of Epidemiology of the Federal Service for 
      Surveillance on Consumer Rights Protection and Human Wellbeing, 111123 Moscow, 
      Russia.
FAU - Subbotina, Ksenia A
AU  - Subbotina KA
AD  - Perm State Medical University named after E. A. Wagner of the Ministry of 
      Healthcare of the Russian Federation, 614000 Perm, Russia.
FAU - Ignatyev, Georgy M
AU  - Ignatyev GM
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Korduban, Anastasia K
AU  - Korduban AK
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Shustova, Elena Y
AU  - Shustova EY
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Bayurova, Ekaterina O
AU  - Bayurova EO
AUID- ORCID: 0000-0002-6160-2203
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Zhitkevich, Alla S
AU  - Zhitkevich AS
AUID- ORCID: 0000-0003-3993-6909
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Avdoshina, Daria V
AU  - Avdoshina DV
AUID- ORCID: 0000-0001-8168-5969
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Piniaeva, Anastasia N
AU  - Piniaeva AN
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Kovpak, Anastasia A
AU  - Kovpak AA
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Antonova, Liliya P
AU  - Antonova LP
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Rogova, Yulia V
AU  - Rogova YV
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Shishova, Anna A
AU  - Shishova AA
AUID- ORCID: 0000-0002-5907-0615
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
AD  - Institute for Translational Medicine and Biotechnology, Sechenov First Moscow 
      State Medical University, 117418 Moscow, Russia.
FAU - Ivin, Yury Y
AU  - Ivin YY
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Sotskova, Svetlana E
AU  - Sotskova SE
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Chernov, Konstantin A
AU  - Chernov KA
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Ipatova, Elena G
AU  - Ipatova EG
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Korduban, Ekaterina A
AU  - Korduban EA
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
FAU - Ishmukhametov, Aydar A
AU  - Ishmukhametov AA
AD  - Chumakov Federal Scientific Center for Research and Development of 
      Immune-and-Biological Products of Russian Academy of Sciences, 108819 Moscow, 
      Russia.
AD  - Institute for Translational Medicine and Biotechnology, Sechenov First Moscow 
      State Medical University, 117418 Moscow, Russia.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230829
PL  - Switzerland
TA  - Viruses
JT  - Viruses
JID - 101509722
RN  - 0 (COVI-VAC)
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Vaccines, Attenuated)
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
SB  - IM
MH  - Humans
MH  - Middle Aged
MH  - Aged
MH  - *COVID-19 Vaccines/adverse effects
MH  - *COVID-19/prevention & control
MH  - Vaccines, Attenuated
MH  - Antibodies, Neutralizing
MH  - Antibodies, Viral
PMC - PMC10537914
OTO - NOTNLM
OT  - 18-60 age cohort
OT  - 60+ age cohort
OT  - COVID-19
OT  - inactivated vaccine
OT  - neutralizing antibodies
OT  - phase I-II clinical trials
COIS- A.A.I., A.A.S. (Aleksandra A. Siniugina), V.P.V., M.S.D., L.V.G., N.A.K., R.D.T., 
      G.M.I., A.K.K., E.Y.S., E.O.B., A.S.Z., D.V.A., A.N.P., A.A.K. (Anastasia A. 
      Kovpak), L.P.A., Y.V.R., A.A.S. (Anna A. Shishova), Y.Y.I., S.E.S., K.A.C, 
      E.G.I., E.A.K., L.I.K. and I.V.G. are employees at the Chumakov Federal 
      Scientific Center for Research and Development of Immune-and-Biological Products 
      of Russian Academy of Sciences, which developed and manufactured CoviVac.
EDAT- 2023/09/28 06:42
MHDA- 2023/10/04 06:43
PMCR- 2023/08/29
CRDT- 2023/09/28 01:44
PHST- 2023/06/15 00:00 [received]
PHST- 2023/08/04 00:00 [revised]
PHST- 2023/08/09 00:00 [accepted]
PHST- 2023/10/04 06:43 [medline]
PHST- 2023/09/28 06:42 [pubmed]
PHST- 2023/09/28 01:44 [entrez]
PHST- 2023/08/29 00:00 [pmc-release]
AID - v15091828 [pii]
AID - viruses-15-01828 [pii]
AID - 10.3390/v15091828 [doi]
PST - epublish
SO  - Viruses. 2023 Aug 29;15(9):1828. doi: 10.3390/v15091828.