IMMUNOGENICITY AND ADVERSE EVENTS AFTER VACCINATION WITH GAM-COVID-VAC (SPUTNIK V) IN PATIENTS ON MAINTENANCE HAEMODIALYSIS COMPARED WITH HEALTHY CONTROLS: A PRELIMINARY REPORT

ABSTRACT

BACKGROUND AND AIMS: Recent studies evaluated safety and efficacy of vaccines against coronavirus disease (COVID-19), but none of them are currently approved in Russia. Here, we report results on immunogenicity of the recombinant adenovirus (rAd) 26 and rAd5 vector-based COVID-19 vaccine Gam-COVID-Vac (Sputnik V, developed by Gamaleya National Research Centre, Russia) in patients, receiving maintenance haemodialysis (HD). We aimed to compare the strength of humoral and cellular immunity after 2 doses of Gam-COVID-Vac in patients receiving HD and individuals with normal kidney function. METHOD: The prospective cohort study (NCT 04 805 632) included 23 patients treated with maintenance HD and 28 volunteers with normal kidney function. All participates were adult, had been fully vaccinated with Gam-COVID-Vac vaccine and had no prior history of suspected or confirmed COVID-19. Subjects were excluded if they had a history of confirmed SARS-CoV-2 infection, had underlying autoimmune disease, malignancies or concomitant immunosuppressive therapy. In all participants the levels of specific IgG were quantified at 4 weeks after second vaccine dose administration using a semi-quantitative SARS-CoV-2 S1 IgG enzymelinked immunosorbent assay. In all subjects, specific CD4+ and CD8+ T-lymphocyte responses (count of spots to spike structural peptide of SARS-CoV-2 virus in IGRA test) were evaluated at the same timepoint. All the participants were asked to report adverse events (AEs) following first and second vaccine administration, included general malaise, fever, myalgia, headache, allergic reactions and injection site reactions. RESULTS: Overall, the incidence of vaccine-associated AEs was less in HD patients than in healthy controls 32% versus 75% after both first and second vaccine administrations, RR = 0.46 (95% confidence interval 0.24-0.79), P = 009 (Table 1). The most commonly reported AE in both groups was pain in the injection site. No severe or serious AEs occurred in both patients and healthy controls. The seroconversion rate in 4 weeks after second vaccine shot reached 100% (28 of 28) in healthy subjects and 87% (20 of 23) in patients receiving HD. IgG levels did not differ between groups 4.7 [Q1-Q3 3.37;6.25] in HD patients versus 5.5 [Q1-Q3 3.3;7.2] in controls, P = 0.219 (Figure 1A). The T-test result was positive in 70% (16 of 23) of HD patients and in 79% (22 of 28) of controls. The magnitude of T-cell response was comparable between groups 30 spots [Q1-Q3 11;48] in HD patients versus 30 spots [Q1-Q3 14;51] in controls, P = 0.745 (Figure 1B). CONCLUSION: Patients receiving HD develop efficient humoral and cellular immune responses after complete vaccination against COVID-19 with Gam-COVID-Vac vaccine, which is comparable with those in healthy adults.