PMID- 38276672
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240129
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 12
IP  - 1
DP  - 2024 Jan 19
TI  - Safety and Immunogenicity of the Convacell((R)) Recombinant N Protein COVID-19 
      Vaccine.
LID - 10.3390/vaccines12010100 [doi]
LID - 100
AB  - We have developed Convacell((R))-a COVID-19 vaccine based on the recombinant 
      nucleocapsid (N) protein of SARS-CoV-2. This paper details Convacell's((R)) 
      combined phase I/II and IIb randomized, double-blind, interventional clinical 
      trials. The primary endpoints were the frequency of adverse effects (AEs) and the 
      titers of specific anti-N IgGs induced by the vaccination; secondary endpoints 
      included the nature of the immune response. Convacell((R)) demonstrated high safety 
      in phase I with no severe AEs detected, 100% seroconversion by day 42 and high 
      and sustained for 350 days anti-N IgG levels in phase II. Convacell((R)) also 
      demonstrated a fused cellular and humoral immune response. Phase IIb results 
      showed significant post-vaccination increases in circulating anti-N IgG and N 
      protein-specific IFNgamma(+)-producing PBMC quantities among 438 volunteers. 
      Convacell((R)) showed same level of immunological efficacy for single and double 
      dose vaccination regimens, including for elderly patients. The clinical studies 
      indicate that Convacell((R)) is safe and highly immunogenic.
FAU - Rabdano, Sevastyan
AU  - Rabdano S
AUID- ORCID: 0000-0003-0481-5488
AD  - Saint Petersburg Scientific Research Institute of Vaccines and Serums of the 
      Federal Medical-Biological Agency of Russia (SPbSRIVS), St. Petersburg 198320, 
      Russia.
FAU - Ruzanova, Ellina
AU  - Ruzanova E
AD  - Saint Petersburg Scientific Research Institute of Vaccines and Serums of the 
      Federal Medical-Biological Agency of Russia (SPbSRIVS), St. Petersburg 198320, 
      Russia.
FAU - Makarov, Denis
AU  - Makarov D
AD  - Saint Petersburg Scientific Research Institute of Vaccines and Serums of the 
      Federal Medical-Biological Agency of Russia (SPbSRIVS), St. Petersburg 198320, 
      Russia.
FAU - Vertyachikh, Anastasiya
AU  - Vertyachikh A
AD  - Saint Petersburg Scientific Research Institute of Vaccines and Serums of the 
      Federal Medical-Biological Agency of Russia (SPbSRIVS), St. Petersburg 198320, 
      Russia.
FAU - Teplykh, Valeriya
AU  - Teplykh V
AD  - Saint Petersburg Scientific Research Institute of Vaccines and Serums of the 
      Federal Medical-Biological Agency of Russia (SPbSRIVS), St. Petersburg 198320, 
      Russia.
FAU - Rudakov, German
AU  - Rudakov G
AUID- ORCID: 0000-0002-1526-1161
AD  - Saint Petersburg Scientific Research Institute of Vaccines and Serums of the 
      Federal Medical-Biological Agency of Russia (SPbSRIVS), St. Petersburg 198320, 
      Russia.
FAU - Pletyukhina, Iuliia
AU  - Pletyukhina I
AD  - Saint Petersburg Scientific Research Institute of Vaccines and Serums of the 
      Federal Medical-Biological Agency of Russia (SPbSRIVS), St. Petersburg 198320, 
      Russia.
FAU - Saveliev, Nikita
AU  - Saveliev N
AD  - Saint Petersburg Scientific Research Institute of Vaccines and Serums of the 
      Federal Medical-Biological Agency of Russia (SPbSRIVS), St. Petersburg 198320, 
      Russia.
FAU - Zakharov, Konstantin
AU  - Zakharov K
AD  - LLC "NIC Eco-bezopasnost", St. Petersburg 191119, Russia.
FAU - Alpenidze, Diana
AU  - Alpenidze D
AD  - State Budgetary Health Institution "City Polyclinic No. 117", St. Petersburg 
      194358, Russia.
FAU - Vasilyuk, Vasiliy
AU  - Vasilyuk V
AD  - Department of Toxicology, Extreme and Diving Medicine, North-Western State 
      Medical University named after I.I. Mechnikov, St. Petersburg 191015, Russia.
FAU - Arakelov, Sergei
AU  - Arakelov S
AD  - Saint Petersburg Scientific Research Institute of Vaccines and Serums of the 
      Federal Medical-Biological Agency of Russia (SPbSRIVS), St. Petersburg 198320, 
      Russia.
FAU - Skvortsova, Veronika
AU  - Skvortsova V
AD  - Federal Medical-Biological Agency of Russia, Moscow 115682, Russia.
LA  - eng
PT  - Journal Article
DEP - 20240119
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC10821050
OTO - NOTNLM
OT  - COVID-19
OT  - clinical trial
OT  - nucleocapsid
OT  - recombinant
OT  - subunit
OT  - vaccine
COIS- Sevastyan Rabdano, Iuliia Pletyukhina, Nikita Saveliev, Veronika Skvortsova, and 
      Sergei Arakelov report patents for genetic constructs and vaccine composition. 
      The other authors have no conflicts of interest to declare. Furthermore, the 
      authors declare that they have prepared the article in their "personal capacity", 
      and/or that they are employed at an academic/research institution where research 
      or education is the primary function of the entity.
EDAT- 2024/01/26 12:43
MHDA- 2024/01/26 12:44
PMCR- 2024/01/19
CRDT- 2024/01/26 09:29
PHST- 2023/12/06 00:00 [received]
PHST- 2024/01/12 00:00 [revised]
PHST- 2024/01/17 00:00 [accepted]
PHST- 2024/01/26 12:44 [medline]
PHST- 2024/01/26 12:43 [pubmed]
PHST- 2024/01/26 09:29 [entrez]
PHST- 2024/01/19 00:00 [pmc-release]
AID - vaccines12010100 [pii]
AID - vaccines-12-00100 [pii]
AID - 10.3390/vaccines12010100 [doi]
PST - epublish
SO  - Vaccines (Basel). 2024 Jan 19;12(1):100. doi: 10.3390/vaccines12010100.