Trial reportAmerican journal of kidney diseases : the official journal of the National Kidney Foundation2011
Immunogenicity and efficacy in hemodialysis patients of an AS03(A)-adjuvanted vaccine for 2009 pandemic influenza A(H1N1): a nonrandomized trial.
Trial report in American journal of kidney diseases : the official journal of the National Kidney Foundation, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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Who cites it
19 citing papers in PubMed, 40 citations in OpenAlex.
- Changes of immunogenic profiles between a single dose and one booster influenza vaccination in hemodialysis patients - an 18-week, open-label trial.Scientific reports · 2016Trial
- Risk factors affecting seroconversion after influenza A/H1N1 vaccination in hemodialysis patients.BMC nephrology · 2012Trial
- Article
- From Sharks to Yeasts: Squalene in the Development of Vaccine Adjuvants.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Early Humoral Responses of Hemodialysis Patients after COVID-19 Vaccination with BNT162b2.Clinical journal of the American Society of Nephrology : CJASN · 2021Article
- Article
- Article
- Comparative Effectiveness of High-Dose Versus Standard-Dose Influenza Vaccine Among Patients Receiving Maintenance Hemodialysis.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2020Article
- High-dose influenza vaccine use among patients receiving hemodialysis in the United States, 2010-2013.Vaccine · 2018Article
- Adjuvanted influenza vaccines.Human vaccines & immunotherapeutics · 2018Review
- The role of age-related T-cell differentiation in patients with renal replacement therapy.Immunology and cell biology · 2017Article
- Efficacy of single versus boost vaccination against influenza virus in patients with multiple myeloma.Haematologica · 2015Article
- Prophylactic vaccinations in chronic kidney disease: Current status.Human vaccines & immunotherapeutics · 2015Review
- Immunogenicity of low-dose MF59-adjuvanted 2009 influenza A/H1N1 vaccine in dialysis patients.Clinical and experimental nephrology · 2013Article
- Serological response to influenza A H1N1 vaccine (Pandemrix®) and seasonal influenza vaccine 2009/2010 in renal transplant recipients and in hemodialysis patients.Medical microbiology and immunology · 2012Article
- Influenza vaccine effectiveness in patients on hemodialysis: an analysis of a natural experiment.Archives of internal medicine · 2012Article
- Article
- Influenza A/H1N1 vaccine in patients treated by kidney transplant or dialysis: a cohort study.Clinical journal of the American Society of Nephrology : CJASN · 2011Article
- Cost-effectiveness of adjuvanted versus nonadjuvanted influenza vaccine in adult hemodialysis patients.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2011Article
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Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHemodialysis patients have a reduced response to vaccinations because of uremia-related immune dysfunction. To increase the immunogenicity of vaccines, antigens can be formulated with adjuvants. The new tocopherol-containing adjuvant system AS03(A) has not been tested yet in patients with end-stage renal disease. STUDY
designNonrandomized trial. SETTING &
participants291 hemodialysis patients from 3 dialysis units co-operating with the Department of Nephrology at the University Hospital Heidelberg, Germany: 169 patients were vaccinated using either 1 (64 patients) or 2 doses (105 patients); 123 patients refused the vaccination and served as controls.
interventionIntramuscular immunization with 3.75 μg of an inactivated split-virion A/California/7/2009 H1N1v pandemic vaccine adjuvanted with AS03(A) in a single- or double-dose regimen. OUTCOMES: A pandemic influenza A immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) response >11 AU (arbitrary units) was defined as a positive response. MEASUREMENTS: Quantitative antibody testing using the pandemic influenza A IgG ELISA. Antibody titers were tested 3 months after vaccination and compared with nonimmunized dialysis patients.
resultsAfter vaccination against 2009 pandemic influenza A(H1N1), 41 of 64 (64.1%) patients with 1 vaccination and 93 of 105 (88.6%) with 2 vaccinations showed a protective immune response compared with 43 of 123 (34.9%) unvaccinated patients (P < 0.001). Logistic regression analysis confirmed vaccination dose as an independent factor for response to pandemic H1N1 vaccination. No episode of pandemic H1N1 illness occurred in any group within the study period of 6 months after vaccination. No serious adverse events occurred, and local symptoms ranged from mild to moderate in 143 of 169 (84.6%) patients. LIMITATIONS: Nonrandomized assignment; use of nontreated patients as controls; no comparison to nonadjuvanted vaccines; dose variation in the intervention group.
conclusionsPandemic H1N1 vaccine adjuvanted with AS03(A) is immunogenic, effective, and safe in hemodialysis patients.
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