The Features of COVID-19’s Course and the Efficacy of the Gam-COVID-Vac Vaccine in Patients with Paroxysmal Nocturnal Hemoglobinuria
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 ass...
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MDPI AG
2023-09-01
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| Series: | Hematology Reports |
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| Online Access: | https://www.mdpi.com/2038-8330/15/3/52 |
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| author | Vadim Ptushkin Evgeniya Arshanskaya Olga Vinogradova Dmitry Kudlay Eugene Nikitin |
| author_facet | Vadim Ptushkin Evgeniya Arshanskaya Olga Vinogradova Dmitry Kudlay Eugene Nikitin |
| author_sort | Vadim Ptushkin |
| collection | DOAJ |
| description | 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<sup>®</sup>) 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%) (<i>p</i> = 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 <i>RBD</i> 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 (<i>p</i> = 0.047). Therapy type, including eculizumab, did not have a significant impact on RBD IgG titers (<i>p</i> > 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. |
| first_indexed | 2024-03-10T22:42:55Z |
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| institution | Directory Open Access Journal |
| issn | 2038-8330 |
| language | English |
| last_indexed | 2024-03-10T22:42:55Z |
| publishDate | 2023-09-01 |
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| record_format | Article |
| series | Hematology Reports |
| spelling | doaj.art-f49c08b821c74431a6c611dee01c53bf2023-11-19T10:57:32ZengMDPI AGHematology Reports2038-83302023-09-0115350351210.3390/hematolrep15030052The Features of COVID-19’s Course and the Efficacy of the Gam-COVID-Vac Vaccine in Patients with Paroxysmal Nocturnal HemoglobinuriaVadim Ptushkin0Evgeniya Arshanskaya1Olga Vinogradova2Dmitry Kudlay3Eugene Nikitin4Moscow City Hematology Center, S.P. Botkin City Clinical Hospital, Moscow 125284, RussiaMoscow City Hematology Center, S.P. Botkin City Clinical Hospital, Moscow 125284, RussiaMoscow City Hematology Center, S.P. Botkin City Clinical Hospital, Moscow 125284, RussiaDepartment of Pharmacology, Pharmacy Institute, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow 119991, RussiaMoscow City Hematology Center, S.P. Botkin City Clinical Hospital, Moscow 125284, RussiaCOVID-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<sup>®</sup>) 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%) (<i>p</i> = 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 <i>RBD</i> 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 (<i>p</i> = 0.047). Therapy type, including eculizumab, did not have a significant impact on RBD IgG titers (<i>p</i> > 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.https://www.mdpi.com/2038-8330/15/3/52paroxysmal nocturnal hemoglobinuriaCOVID-19Gam-COVID-VacSARS-CoV-2anti-SARS-CoV-2 IgGeculizumab |
| spellingShingle | Vadim Ptushkin Evgeniya Arshanskaya Olga Vinogradova Dmitry Kudlay Eugene Nikitin The Features of COVID-19’s Course and the Efficacy of the Gam-COVID-Vac Vaccine in Patients with Paroxysmal Nocturnal Hemoglobinuria Hematology Reports paroxysmal nocturnal hemoglobinuria COVID-19 Gam-COVID-Vac SARS-CoV-2 anti-SARS-CoV-2 IgG eculizumab |
| title | The Features of COVID-19’s Course and the Efficacy of the Gam-COVID-Vac Vaccine in Patients with Paroxysmal Nocturnal Hemoglobinuria |
| title_full | The Features of COVID-19’s Course and the Efficacy of the Gam-COVID-Vac Vaccine in Patients with Paroxysmal Nocturnal Hemoglobinuria |
| title_fullStr | The Features of COVID-19’s Course and the Efficacy of the Gam-COVID-Vac Vaccine in Patients with Paroxysmal Nocturnal Hemoglobinuria |
| title_full_unstemmed | The Features of COVID-19’s Course and the Efficacy of the Gam-COVID-Vac Vaccine in Patients with Paroxysmal Nocturnal Hemoglobinuria |
| title_short | The Features of COVID-19’s Course and the Efficacy of the Gam-COVID-Vac Vaccine in Patients with Paroxysmal Nocturnal Hemoglobinuria |
| title_sort | features of covid 19 s course and the efficacy of the gam covid vac vaccine in patients with paroxysmal nocturnal hemoglobinuria |
| topic | paroxysmal nocturnal hemoglobinuria COVID-19 Gam-COVID-Vac SARS-CoV-2 anti-SARS-CoV-2 IgG eculizumab |
| url | https://www.mdpi.com/2038-8330/15/3/52 |
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