Efficacy of Influenza A H1n1/09 Vaccine in Hemodialysis and Kidney Transplant Patients

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Clin J Am Soc Nephrol 6: ●●●?●●●, 2011. doi: 10.2215/CJN.02160311


Efficacy of Influenza A H1n1/09 Vaccine in
Hemodialysis and Kidney Transplant Patients


Marta Crespo,* Silvia Collado,* Marisa Mir,* Higini Cao,* Francesc Barbosa,* Consol Serra,? Carlota Hidalgo,*
Anna Faura,* Milagros Montero,? Juan Garc?a de Lomas,? Juan P. Horcajada,? Josep M. Puig,* and Julio Pascual*
Summary
Background and objectives Data are needed to assess safety and efficacy of the 2009 pandemic influenza A
H1N1 vaccine in renal patients.
Design, setting, participants, & measurements We prospectively evaluated seroconversion, predictors of response,
and vaccine safety in renal patients. Hemagglutination inhibition tests to detect serum antibodies
against a new Influenza A-H1N1 virus were performed in 79 transplant patients, 48 hemodialysis patients,
and 15 healthy workers before and 1 mo after vaccination. Healthy controls and 88/127 renal patients were
vaccinated. Seroconversion was defined as at least 2 dilutions increase in titer.
Results We excluded 19 individuals seroprotected (
1/40) against the novel H1N1 in the initial sample. Efficacy
rate in the 96 vaccinated individuals was 43.7% (42/96 seroconverted versus 4/27 nonvaccinated patients,
P
0.007). For vaccinated subgroups, efficacy was 41.8% in transplant patients (P
0.039 versus
nonvaccinated), 33.3% in hemodialysis patients (P
0.450), and 81.8% in controls. Healthy controls showed
better response to vaccine than transplant (P
0.021) and dialysis patients (P
0.012). For the transplant
subgroup, longer time after transplantation (P
0.028) was associated with seroconversion, but no influence
was found for age, sex, renal function, or immunosuppression. In the hemodialysis subgroup, younger
age was associated with response (55.7  20.8 versus 71.6  10.1 yr, P
0.042), but other specific variables,
including KT/V or time on dialysis, were not. No serious adverse events were reported, and kidney function
was stable.
Conclusion The novel influenza A 2009 H1N1 vaccine was safe in renal patients, although administration of
a single dose of adjuvanted vaccine induced a poor response in these patients.

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Re: Efficacy of Influenza A H1n1/09 Vaccine in Hemodialysis and Kidney Transplant Patients

H1N1 Flu Vaccine Safe In Patients With Kidney Failure Or Transplant


When the influenza A (H1N1) virus swept around the world in spring 2009, infection was presumed to be more common in immunosuppressed patients, such as those who have had a kidney transplant. Later that year, the International Societies of Transplantation recommended that transplant recipients receive at least one dose of the H1N1 vaccine, although there was no information on the efficacy of the vaccine in that population.

Marta Crespo, MD, and Julio Pascual, MD, PhD (Parc de Salut Mer, Barcelona, Spain), have now evaluated the efficacy of the H1N1 vaccine in patients who had received a kidney transplant, as well as those on hemodialysis. They found the vaccine was safe in kidney patients, but using a single dose of the vaccine produced a poor response in patients, according to a study recently published in the Clinical Journal of American Society of Nephrology.

Included in the study were 79 kidney transplant patients, 48 hemodialysis patients, and 15 healthcare workers who had normal kidney function. All who were vaccinated received one dose of the vaccine; blood samples were tested for antibodies against the virus before vaccination and 8 weeks after.

Of the 96 people (including controls) who received the vaccine, 43.7% (42/96) developed antibodies (seroconverted). That included 41.8% of those in the kidney transplant group, 33.3% of those on hemodialysis, and 81.8% of the healthy controls. The healthy control group had a significantly better response than the other two groups; there was no significant difference in response between the other two groups. Overall, younger people were more likely to seroconvert. In the transplant group, patients who had more time since transplantation were more likely to seroconvert than those with recent transplants, and in the hemodialysis group, younger patients were more likely to seroconvert. No severe adverse effects were seen.

Although the study protocol was similar to that advised by the transplantation society, "administration of a single dose of adjuvanted vaccine produced a poor response" in transplant and dialysis patients, compared to the healthy controls, noted the study authors. "In our experience, recently transplanted patients and older patients on hemodialysis are two special populations that probably need at least two doses of vaccine to seroconvert."

"Renal patients do not show the same responses to medical problems as the general population," said Dr. Crespo. "Specific studies must be performed to evaluate the efficacy and safety of measure such as vaccination against the influenza A H1N1."

Study co-authors include Silvia Collado, Marisa Mir, Higini Cao, Francesc Barbosa, Consol Serra, Carlota Hidalgo, Anna Faura, Milagros Montero, Juan Garc?a de Lomas, Juan Horcajada, and Josep M. Puig.

Disclosures: The authors of this manuscript have conflicts of interest to disclose as described by the Journal of the American Society of Nephrology. The study was performed, in part, with funding from the project ISCIII PII0/01370.

Source: American Society of Nephrology (ASN)

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