Kidney medicine · 2026
Humoral and Cellular Immune Responses Following Bivalent SARS-CoV-2 mRNA Vaccines in Patients Undergoing Hemodialysis: A Prospective Cohort Study.
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Ling Tsai-Chieh, Chen Po-Lin, Wang Jen-Ren, Ko Wen-Chien, Chao Chiao-Hsuan, Shieh Chi-Chang, Wu Jia-Ling, Sun Chien-Yao, Lin Wei-Ren, Huang Chieh-Hsin, Chang Yu-Tzu
Аннотация
RATIONALE & OBJECTIVE: Hemodialysis (HD) patients are susceptible to severe illness and mortality from coronavirus disease (COVID)-19. We investigated immunogenicity following bivalent vaccines containing ancestral and omicron variant (BA.1 or BA.4/BA.5) antigens in HD patients.
STUDY DESIGN: A prospective observational cohort study.
SETTING & PARTICIPANTS: We enrolled adult HD patients and age-matched healthy adults between October 2022 and February 2023. Blood samples were taken at baseline, 1 month (M1), and 3 months (M3) postvaccination.
EXPOSURES: Bivalent mRNA vaccines.
OUTCOMES: Anti-SARS-CoV-2 spike protein receptor-binding domain antibodies, surrogate viral neutralization tests, pseudovirus neutralization tests, and SARS-CoV-2-specific interferon-γ release assay.
ANALYTIC APPROACH: Continuous variables were assessed using t test, Mann-Whitney U test, or Kruskal-Wallis test with Dunn's post hoc test; categorical variables were assessed using chi-square test or Fisher exact test. Holm-Bonferroni correction was applied for multiple comparisons.
RESULTS: Among 106 HD patients, 89.6% and 10.4% received either Spikevax Original/Omicron BA.1 or BA.4/5. Prior SARS-CoV-2 infection was documented in 25.5%, and 93.4% had received four monovalent vaccine doses. Anti-SARS-CoV-2-S antibody levels demonstrated a 4.2-fold increase at M1, subsequently declining by 50% at M3. Surrogate viral neutralization tests showed enhanced neutralization against Omicron BA.1, BA.2, and BA.4/5, with seropositive rates of 75.3% to 96% maintained at M3. Infection-naïve patients exhibited lower baseline antibodies but demonstrated more pronounced booster responses compared with previously infected individuals. Pseudovirus neutralization tests demonstrated 2-to-9.9-fold increases at M1 in neutralizing capacity against emerging Omicron subvariants BF.7, BA.2.75, BQ.1.1, and XBB.1.5. However, only 58.1% of patients demonstrated positive SARS-CoV-2-specific interferon-γ release assay responses at M1, with no correlation to humoral outcomes. Immune responses were comparable between HD patients and healthy controls.
LIMITATIONS: Limited sample size, heterogeneous vaccination and infection history.
CONCLUSIONS: Bivalent mRNA vaccines significantly enhanced antibody titers and broadened neutralizing capacity against emerging Omicron subvariants in HD patients. However, cellular immunity remained suboptimal despite multiple antigen exposures, highlighting the need for optimized vaccination strategies in this immunocompromised population.
STUDY DESIGN: A prospective observational cohort study.
SETTING & PARTICIPANTS: We enrolled adult HD patients and age-matched healthy adults between October 2022 and February 2023. Blood samples were taken at baseline, 1 month (M1), and 3 months (M3) postvaccination.
EXPOSURES: Bivalent mRNA vaccines.
OUTCOMES: Anti-SARS-CoV-2 spike protein receptor-binding domain antibodies, surrogate viral neutralization tests, pseudovirus neutralization tests, and SARS-CoV-2-specific interferon-γ release assay.
ANALYTIC APPROACH: Continuous variables were assessed using t test, Mann-Whitney U test, or Kruskal-Wallis test with Dunn's post hoc test; categorical variables were assessed using chi-square test or Fisher exact test. Holm-Bonferroni correction was applied for multiple comparisons.
RESULTS: Among 106 HD patients, 89.6% and 10.4% received either Spikevax Original/Omicron BA.1 or BA.4/5. Prior SARS-CoV-2 infection was documented in 25.5%, and 93.4% had received four monovalent vaccine doses. Anti-SARS-CoV-2-S antibody levels demonstrated a 4.2-fold increase at M1, subsequently declining by 50% at M3. Surrogate viral neutralization tests showed enhanced neutralization against Omicron BA.1, BA.2, and BA.4/5, with seropositive rates of 75.3% to 96% maintained at M3. Infection-naïve patients exhibited lower baseline antibodies but demonstrated more pronounced booster responses compared with previously infected individuals. Pseudovirus neutralization tests demonstrated 2-to-9.9-fold increases at M1 in neutralizing capacity against emerging Omicron subvariants BF.7, BA.2.75, BQ.1.1, and XBB.1.5. However, only 58.1% of patients demonstrated positive SARS-CoV-2-specific interferon-γ release assay responses at M1, with no correlation to humoral outcomes. Immune responses were comparable between HD patients and healthy controls.
LIMITATIONS: Limited sample size, heterogeneous vaccination and infection history.
CONCLUSIONS: Bivalent mRNA vaccines significantly enhanced antibody titers and broadened neutralizing capacity against emerging Omicron subvariants in HD patients. However, cellular immunity remained suboptimal despite multiple antigen exposures, highlighting the need for optimized vaccination strategies in this immunocompromised population.