BACKGROUND: Non-dialysis-dependent chronic kidney disease (CKD-ND) patients are recommended to receive a one-dose influenza vaccination annually . However, studies investigating vaccine efficacy in the CKD-ND population are still lacking . In this study, we aimed to evaluate vaccine efficacy between the one-dose and two-dose regimen and among patients with different stages of CKD throughout a 20-week follow-up period .
METHODS: We conducted a single-center, non-randomized, open-label, controlled trial among patients with all stages of CKD-ND . Subjects were classified as unvaccinated, one-dose, and two-dose groups (4 weeks apart) after enrollment . Serial changes in immunological parameters (0 , 4 , 8, and 20 weeks after enrollment), including seroprotection, geometric mean titer (GMT), GMT fold-increase, seroconversion, and seroresponse, were applied to evaluate vaccine efficacy .
RESULTS: There were 43 , 84, and 71 patients in the unvaccinated, one-dose, and two-dose vaccination groups, respectively . At 4-8 weeks after vaccination, seroprotection rates in the one- and two-dose group for H1N1, H3N2, and B ranged from 82.6-95.8% , 97.4-100%, and 73.9-100%, respectively . The concomitant seroconversion and GMT fold-increases nearly met the suggested criteria for vaccine efficacy for the elderly population . Although the seroprotection rates for all of the groups were adequate, the seroconversion and GMT fold-increase at 20 weeks after vaccination did not meet the criteria for vaccine efficacy . The two-dose regimen had a higher probability of achieving seroprotection for B strains (Odds ratio : 3.5 , 95% confidence interval (1.30-9.40) ). No significant differences in vaccine efficacy were found between early (stage 1-3) and late (stage 4-5) stage CKD .
CONCLUSIONS: The standard one-dose vaccination can elicit sufficient protective antibodies . The two-dose regimen induced a better immune response when the baseline serum antibody titer was low . Monitoring change in antibody titers for a longer duration is warranted to further determine the current vaccine strategy in CKD-ND population.
Index: booster dosage, immune response, influenza virus, non-dialysis-dependent chronic kidney disease, vaccine