Original Investigation
Dialysis
Immunogenicity of a Standard Trivalent Influenza Vaccine in Patients on Long-term Hemodialysis: An Open-Label Trial

https://doi.org/10.1053/j.ajkd.2008.11.032Get rights and content

Background

Disturbances in acquired immunity are considered to be responsible, at least in part, for the high infection rate and inadequate response to vaccinations observed in hemodialysis (HD) patients. The present prospective trial aimed to: (1) evaluate the immunogenicity of a standard influenza vaccine in HD patients, and (2) identify determinants of the immune response.

Study Design

Prospective interventional open-label study.

Setting & Participants

201 long-term HD patients and 41 healthy volunteers.

Intervention

Vaccination with a standard trivalent inactivated influenza vaccine.

Outcomes

The primary outcome was seroprotection rate, defined as percentage of participants with an antibody titer of 40 or greater 1 month after vaccination.

Measurements

All antibody titers were determined in duplicate by using the hemagglutination inhibition assay. Regression analyses were performed to investigate the association between demographics, uremic retention solutes (including p–cresol), inflammation, nutrition, iron status, trace elements, and immune response in HD patients.

Results

More than 80% of HD patients showed seroprotection after vaccination. The immune response of HD patients was similar to that of healthy volunteers. Booster vaccination did not improve the immune response. High serum ferritin level was the only parameter independently associated with a better vaccination-induced antibody response in HD patients.

Limitations

A high seroprotection rate at baseline undermined the power to identify clinical determinants of the immune response.

Conclusions

Influenza vaccination is as efficacious in HD patients as in healthy volunteers. With the exception of serum ferritin, none of the investigated parameters of nutrition, inflammation, and dialysis adequacy had a significant impact on the immune response. Our data support annual vaccination of HD patients and question the clinical relevance of disturbances in acquired immunity in contemporary HD patients.

Section snippets

Participants

During the 2003 to 2004 influenza season, 201 stable HD patients were enrolled from 2 different units (University Hospitals, Leuven, and Virga Jesse Hospital, Hasselt, Belgium). All patients were dialyzed thrice weekly for 4 hours with synthetic membranes. Patients treated with immunosuppressive drugs or with known allergy to chicken proteins were excluded. Forty-one hospital staff members were recruited as controls. The study was approved by the local ethics committee. All patients gave

Study Population

Baseline clinical characteristics of HD patients are listed in Table 1. HD patients were significantly older (67 ± 14 versus 56 ± 7 years; P < 0.001) and were more often vaccinated against influenza (81.7% versus 60.0%; P < 0.05) in the preceding influenza season compared with healthy volunteers. There were also proportionally more men in the HD cohort (60.7% versus 29.3%; P < 0.001). Patients with seroprotection against none of the influenza strains at baseline (n = 16) had significantly lower

Discussion

To the best of our knowledge, this study is the largest prospective study ever performed in HD patients evaluating antibody response after influenza vaccination and factors affecting this response. The major findings are as follows: (1) influenza vaccination confers high seroprotection rates (ranging from 81% to 87%) in HD patients, (2) the immune response to influenza vaccination is similar in HD patients and healthy volunteers, (3) a booster dose does not improve seroprotection rates, and (4)

Acknowledgements

Results presented in this report have been published previously in abstract format. Nephrol Dial Transplant 22:228, 2007.

Support: Part of this study was supported by an unrestricted grant from Roche Pharmaceuticals. The company did not take part in the design of the study, collection or analysis of the data, writing of the report, or the decision to publish the report.

Financial Disclosure: None.

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    Originally published online as doi: 10.1053/j.ajkd.2008.11.032 on April 2, 2009.

    Trial registration: www.clinicaltrials.gov; study number: NCT00776750.

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