PMID- 37754667
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231003
IS  - 2038-8322 (Print)
IS  - 2038-8330 (Electronic)
IS  - 2038-8322 (Linking)
VI  - 15
IP  - 3
DP  - 2023 Sep 1
TI  - The Features of COVID-19's Course and the Efficacy of the Gam-COVID-Vac Vaccine 
      in Patients with Paroxysmal Nocturnal Hemoglobinuria.
PG  - 503-512
LID - 10.3390/hematolrep15030052 [doi]
AB  - COVID-19 and other infectious diseases can exacerbate the course of paroxysmal 
      nocturnal hemoglobinuria (PNH). The efficacy and safety of the Gam-COVID-Vac 
      vaccine in patients with PNH has not been adequately studied. A retrospective, 
      observational, cohort, non-comparative study was performed to assess the course 
      of COVID-19 as well as the safety and efficacy of the Gam-COVID-Vac (Sputnik V) 
      vaccine in patients with paroxysmal nocturnal hemoglobinuria (PNH). The study 
      included data from 52 patients with PNH aged 18 to 75 years, 38 of whom received 
      background therapy with eculizumab (Elizaria((R))) between March 2020 and January 
      2022. COVID-19 was diagnosed according to the results of PCR testing. The 
      patients were divided into two groups for comparison of the incidence of 
      COVID-19. Group 1 included non-vaccinated patients with PNH, and Group 2 included 
      patients vaccinated prior to the onset of COVID-19. According to vaccination, 
      patients were subdivided into non-vaccinated and vaccinated groups without signs 
      of previous COVID-19 at the beginning of the analyzed period, and patients 
      vaccinated half a year or more after recovery from COVID-19. Testing for 
      anti-SARS-CoV-2 IgG levels was carried out in patients with PNH in the year after 
      their COVID-19. Tests for anti-SARS-CoV-2 RBD IgG levels were performed on 
      vaccinated patients. In total, 28 (53.8%) of the enrolled patients had COVID-19, 
      including asymptomatic forms in 7 (25%) and mild forms in 16 (57%) patients. A 
      total of 22 (42.3%) patients were fully vaccinated with Gam-COVID-Vac, of which 
      13 (25%) patients were vaccinated without the signs of previous 
      SARS-CoV-2infection, and 9 (17.3%) patients were vaccinated after COVID-19. The 
      number of patients who had COVID-19 was about two times higher in Group 1 
      (non-vaccinated; 24) (61.5%), whereas in Group 2 (vaccinated), the number of 
      patients with COVID-19 was only 4 (30.8%). The proportion and number of patients 
      who did not have COVID-19 was higher in the group of vaccinated patients (9; 
      69.2%) than in the group of non-vaccinated patients (15; 38.5%) (p = 0.054). In 
      patients who had been infected with COVID-19, maximum concentrations of 
      anti-SARS-CoV-2 IgG were observed 2-3 months after the acute infection phase, 
      followed by a gradual decline by month 9-10. The mean RBD IgG concentration was 
      higher in the group of patients who had been infected by COVID-19 than in the 
      group of patients without COVID-19 (p = 0.047). Therapy type, including 
      eculizumab, did not have a significant impact on RBD IgG titers (p > 0.05). 
      Hospitalization was required in five (18%) patients, all of whom had breakthrough 
      hemolysis and severe lung damage on CT scans. After the first dose, adverse 
      events (AEs) were reported in 41% of the patients (body temperature increased in 
      18%; headache in 13.6%; and pain in joints in 4.5%; colitis exacerbation was 
      observed in 4.5%). After the second dose, no AEs were reported. The performed 
      study suggests the possible efficacy and demonstrates the safety of Gam-COVID-Vac 
      (Sputnik V) for the prophylaxis of COVID-19 in patients with PNH who experience 
      immunosuppression due to target therapy.
FAU - Ptushkin, Vadim
AU  - Ptushkin V
AUID- ORCID: 0000-0002-9368-6050
AD  - Moscow City Hematology Center, S.P. Botkin City Clinical Hospital, Moscow 125284, 
      Russia.
AD  - Department of Oncology, Hematology and Radiation Therapy, Pirogov Russian 
      National Research Medical University, Moscow 117997, Russia.
FAU - Arshanskaya, Evgeniya
AU  - Arshanskaya E
AD  - Moscow City Hematology Center, S.P. Botkin City Clinical Hospital, Moscow 125284, 
      Russia.
FAU - Vinogradova, Olga
AU  - Vinogradova O
AD  - Moscow City Hematology Center, S.P. Botkin City Clinical Hospital, Moscow 125284, 
      Russia.
AD  - Department of Oncology, Hematology and Radiation Therapy, Pirogov Russian 
      National Research Medical University, Moscow 117997, Russia.
FAU - Kudlay, Dmitry
AU  - Kudlay D
AUID- ORCID: 0000-0003-1878-4467
AD  - Department of Pharmacology, Pharmacy Institute, I.M. Sechenov First Moscow State 
      Medical University (Sechenov University), Moscow 119991, Russia.
FAU - Nikitin, Eugene
AU  - Nikitin E
AD  - Moscow City Hematology Center, S.P. Botkin City Clinical Hospital, Moscow 125284, 
      Russia.
AD  - Hematology and Transfusiology Department, Russian Medical Academy of Continuous 
      Professional Education, Moscow 125993, Russia.
LA  - eng
PT  - Journal Article
DEP - 20230901
PL  - Switzerland
TA  - Hematol Rep
JT  - Hematology reports
JID - 101556723
PMC - PMC10531158
OTO - NOTNLM
OT  - COVID-19
OT  - Gam-COVID-Vac
OT  - SARS-CoV-2
OT  - anti-SARS-CoV-2 IgG
OT  - eculizumab
OT  - paroxysmal nocturnal hemoglobinuria
COIS- The authors declare no conflict of interest.
EDAT- 2023/09/27 12:41
MHDA- 2023/09/27 12:42
PMCR- 2023/09/01
CRDT- 2023/09/27 09:05
PHST- 2023/03/20 00:00 [received]
PHST- 2023/07/14 00:00 [revised]
PHST- 2023/07/24 00:00 [accepted]
PHST- 2023/09/27 12:42 [medline]
PHST- 2023/09/27 12:41 [pubmed]
PHST- 2023/09/27 09:05 [entrez]
PHST- 2023/09/01 00:00 [pmc-release]
AID - hematolrep15030052 [pii]
AID - hematolrep-15-00052 [pii]
AID - 10.3390/hematolrep15030052 [doi]
PST - epublish
SO  - Hematol Rep. 2023 Sep 1;15(3):503-512. doi: 10.3390/hematolrep15030052.