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Poor immune response to a standard single dose non-adjuvanted vaccination against 2009 pandemic H1N1 influenza virus A in the adult and elder hemodialysis patients.
Vaccine. 2012 Jul 13; 30(33):5009-18.V

Abstract

BACKGROUND

Hemodialysis patients have higher risk of mortality and morbidity when infected with 2009 pandemic H1N1 (pH1N1/09) virus. Depending on different methodologies and criteria, previous studies reported variable response rates to adjuvanted vaccines against pH1N1/09 virus in hemodialysis patients, however, the efficacy of non-adjuvanted vaccines, which are currently used in many countries such as the USA and Asian areas, has not been comprehensively evaluated in hemodialysis population before.

METHODS

We evaluated the efficacy of a standard single 15 μg-dose of non-adjuvanted monovalent pH1N1/09 vaccine (AdimFlu-S) in vaccine-naïve 110 hemodialysis and 173 healthy participants. When enrolling, all participants had not any clinical symptom or sign suggesting pH1N1/09 infection since the index case was identified in Taiwan. Sera from all participants were tested by hemagglutination inhibition (HI) and micro-neutralization-ELISA (microNT-ELISA) tests before and 21 days after vaccination. The outcome parameters were seroconversion rate (≥ 4-fold in HI titer with titer ≥ 1:40), seroprotection rate (HI titers ≥ 1:40), seroresponse rate (≥ 4-fold increase in HI or microNT-ELISA titer), fold of increase in geometric mean (GM) titers, and adverse effects.

RESULTS

In method A analyses, we included all participants' data in final analyses, and the seroconversion rates and the fold increase of GM titer after vaccination were 25.4% and 1.8 in adult (18-60-year olds) hemodialysis subgroup, and 23.4% and 1.8 in elder (>60-year olds) hemodialysis subgroup based on HI titers, which were all significantly lower than those of the corresponding healthy control subgroups. Similar trends were observed based on microNT-ELISA titers, further validating the results. Multivariable analysis revealed hemoglobin and cholesterol levels were significant predictors for seroresponse in hemodialysis patients, suggesting the possible impacts of nutrition status and anemia. In method B analyses, we excluded participants with pre-vaccination seroprotection (based on HI or microNT-ELISA criteria) in final analyses. The response rates in various subgroups from method B analyses were also similar as those from method A analyses. No severe adverse effect was noted.

CONCLUSIONS

According to the European and U.S. criteria, a single 15 μg-dose of non-adjuvanted pH1N1/09 vaccination is safe but ineffective in both adult and elder hemodialysis patients. Further studies using multiple doses or higher antigen amount are warrant to define the most appropriate regimen.

Authors+Show Affiliations

Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22658967

Citation

Chang, Yu-Tzu, et al. "Poor Immune Response to a Standard Single Dose Non-adjuvanted Vaccination Against 2009 Pandemic H1N1 Influenza Virus a in the Adult and Elder Hemodialysis Patients." Vaccine, vol. 30, no. 33, 2012, pp. 5009-18.
Chang YT, Guo CY, Tsai MS, et al. Poor immune response to a standard single dose non-adjuvanted vaccination against 2009 pandemic H1N1 influenza virus A in the adult and elder hemodialysis patients. Vaccine. 2012;30(33):5009-18.
Chang, Y. T., Guo, C. Y., Tsai, M. S., Cheng, Y. Y., Lin, M. T., Chen, C. H., Shen, D., Wang, J. R., & Sung, J. M. (2012). Poor immune response to a standard single dose non-adjuvanted vaccination against 2009 pandemic H1N1 influenza virus A in the adult and elder hemodialysis patients. Vaccine, 30(33), 5009-18. https://doi.org/10.1016/j.vaccine.2012.05.016
Chang YT, et al. Poor Immune Response to a Standard Single Dose Non-adjuvanted Vaccination Against 2009 Pandemic H1N1 Influenza Virus a in the Adult and Elder Hemodialysis Patients. Vaccine. 2012 Jul 13;30(33):5009-18. PubMed PMID: 22658967.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Poor immune response to a standard single dose non-adjuvanted vaccination against 2009 pandemic H1N1 influenza virus A in the adult and elder hemodialysis patients. AU - Chang,Yu-Tzu, AU - Guo,Chao-Yu, AU - Tsai,Ming-Song, AU - Cheng,Ya-Yun, AU - Lin,Meng-Te, AU - Chen,Chien-Hui, AU - Shen,Daphne, AU - Wang,Jen-Ren, AU - Sung,Junne-Ming, Y1 - 2012/05/30/ PY - 2012/02/02/received PY - 2012/05/03/revised PY - 2012/05/10/accepted PY - 2012/6/5/entrez PY - 2012/6/5/pubmed PY - 2012/10/18/medline SP - 5009 EP - 18 JF - Vaccine JO - Vaccine VL - 30 IS - 33 N2 - BACKGROUND: Hemodialysis patients have higher risk of mortality and morbidity when infected with 2009 pandemic H1N1 (pH1N1/09) virus. Depending on different methodologies and criteria, previous studies reported variable response rates to adjuvanted vaccines against pH1N1/09 virus in hemodialysis patients, however, the efficacy of non-adjuvanted vaccines, which are currently used in many countries such as the USA and Asian areas, has not been comprehensively evaluated in hemodialysis population before. METHODS: We evaluated the efficacy of a standard single 15 μg-dose of non-adjuvanted monovalent pH1N1/09 vaccine (AdimFlu-S) in vaccine-naïve 110 hemodialysis and 173 healthy participants. When enrolling, all participants had not any clinical symptom or sign suggesting pH1N1/09 infection since the index case was identified in Taiwan. Sera from all participants were tested by hemagglutination inhibition (HI) and micro-neutralization-ELISA (microNT-ELISA) tests before and 21 days after vaccination. The outcome parameters were seroconversion rate (≥ 4-fold in HI titer with titer ≥ 1:40), seroprotection rate (HI titers ≥ 1:40), seroresponse rate (≥ 4-fold increase in HI or microNT-ELISA titer), fold of increase in geometric mean (GM) titers, and adverse effects. RESULTS: In method A analyses, we included all participants' data in final analyses, and the seroconversion rates and the fold increase of GM titer after vaccination were 25.4% and 1.8 in adult (18-60-year olds) hemodialysis subgroup, and 23.4% and 1.8 in elder (>60-year olds) hemodialysis subgroup based on HI titers, which were all significantly lower than those of the corresponding healthy control subgroups. Similar trends were observed based on microNT-ELISA titers, further validating the results. Multivariable analysis revealed hemoglobin and cholesterol levels were significant predictors for seroresponse in hemodialysis patients, suggesting the possible impacts of nutrition status and anemia. In method B analyses, we excluded participants with pre-vaccination seroprotection (based on HI or microNT-ELISA criteria) in final analyses. The response rates in various subgroups from method B analyses were also similar as those from method A analyses. No severe adverse effect was noted. CONCLUSIONS: According to the European and U.S. criteria, a single 15 μg-dose of non-adjuvanted pH1N1/09 vaccination is safe but ineffective in both adult and elder hemodialysis patients. Further studies using multiple doses or higher antigen amount are warrant to define the most appropriate regimen. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22658967/Poor_immune_response_to_a_standard_single_dose_non_adjuvanted_vaccination_against_2009_pandemic_H1N1_influenza_virus_A_in_the_adult_and_elder_hemodialysis_patients_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)00717-7 DB - PRIME DP - Unbound Medicine ER -