Acceptance and Adverse Events of the 2009 H1N1 Vaccination in Immunosuppressed Pediatric Liver Transplant Recipients

Goldschmidt, Imeke; Pfister, Eva Doreen; Becker, Malte; Häckl, Sebastian; Bott, Oliver J.; Baumann, Ulrich

doi:10.1016/j.jpeds.2010.10.034

Cited by 18 publications

(8 citation statements)

References 11 publications

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“…In addition, in a large series of 364 solid organ transplant recipients (including heart, liver, kidney, and lung transplantation), no adverse effects or rejection episodes were found after vaccination with the adjuvanted 2009 pandemic vaccine (15). Our results with pandemic vaccine concur with the findings of other studies in which no adverse effects or rejection episodes were found in SOT patients receiving the pandemic vaccine (14)(15)(16)(17) In contrast, episodes of acute allograft rejection have also been related with influenza virus infection (23)(24)(25). In these circumstances, the benefits of the vaccine in SOT patients outweigh the potential risk of rejection and support administration of the vaccine in this population.…”

Section: Discussionsupporting

confidence: 88%

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Immunogenicity of pandemic influenza A H1N1/2009 adjuvanted vaccine in pediatric solid organ transplant recipients

Gavaldá

Cabral

Pérez‐Romero

et al. 2013

Pediatric Transplantation

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The aim of this study was to assess the immunogenicity of a vaccine against this virus in a prospective cohort of transplanted pediatric patients without previous influenza infection who received one dose of MF59®-adjuvanted pandemic H1N1/2009 vaccine. Seventeen patients who were being regularly followed up at the Outpatient Clinic of the Children's Transplant Unit (liver and kidney transplantation) in Hospital Universitari Vall d'Hebron (Barcelona) were included. Seroconversion was demonstrated in 15 of 17 (88.2%) vaccinated children. There were no rejection episodes or major adverse events. The MF59(®) -adjuvanted pandemic H1N1/2009 vaccine was safe and elicited an adequate response.

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Section: Discussionsupporting

confidence: 88%

“…In contrast, episodes of acute allograft rejection have also been related with influenza virus infection . In these circumstances, the benefits of the vaccine in SOT patients outweigh the potential risk of rejection and support administration of the vaccine in this population.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity of pandemic influenza A H1N1/2009 adjuvanted vaccine in pediatric solid organ transplant recipients

Gavaldá

Cabral

Pérez‐Romero

et al. 2013

Pediatric Transplantation

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“…[56] reported that vaccination of heart transplant recipients can reduce the proportion of patients developing influenza‐like illness. In a retrospective analysis of paediatric liver transplant patients vaccinated with the pandemic H1N1 vaccine, the frequency of infection was 4% compared with 25% in unvaccinated patients [57].…”

mentioning

confidence: 99%

Vaccination of immunocompromised patients

Ljungman

2012

Clinical Microbiology and Infection

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Clin Microbiol Infect 2012; 18 (Suppl. 5): 93–99 Abstract Vaccination of immunocompromised patients is challenging both regarding efficacy and safety. True efficacy data are lacking so existing recommendations are based on immune responses and safety data. Inactivated vaccines can generally be used without risk but the patients who are most at risk for infectious morbidity and mortality as a result of their severely immunosuppressed state are also those least likely to respond to vaccination. However, vaccination against pneumococci, Haemophilus influenzae and influenza are generally recommended. Live vaccines must be used with care because the risk for vaccine‐associated disease exists.

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“…One published report also described SOT rejection in one pancreas transplant recipient immunised with a non-GSK adjuvanted vaccine [17]. By contrast, other studies conducted in Switzerland, Belgium, Spain, Germany and Canada in patients with lung [18], kidney [19, 20], liver [21], pancreas and heart transplants [22, 23] reported no evidence of increased risk of rejection. Most of this research evaluated antibody responses to the vaccines and overall safety, rather than clinical rejection as an outcome.…”

Section: Resultsmentioning

confidence: 99%

Adjuvanted (AS03) A/H1N1 2009 Pandemic Influenza Vaccines and Solid Organ Transplant Rejection: Systematic Signal Evaluation and Lessons Learnt

Santos¹,

Seifert²,

Bauchau

et al. 2017

Drug Saf

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IntroductionWe investigated a signal of solid organ transplant (SOT) rejection after immunisation with (AS03) A/H1N1 2009 pandemic influenza vaccines.MethodsPotential immunological mechanisms were reviewed and quantitative analyses were conducted. The feasibility of pharmacoepidemiological studies was explored.ResultsOverall results, including data from a pharmacoepidemiological study, support the safety of adjuvanted (AS03) pandemic influenza vaccination in SOT recipients. The regulatory commitment to evaluate the signal through a stepwise investigation was closed in 2014.ConclusionLessons learned highlight the importance of investigating plausible biological mechanisms between vaccines and potentially associated adverse outcomes, and the importance of selecting appropriate study settings and designs for safety signal investigations.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-017-0532-3) contains supplementary material, which is available to authorized users.

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Acceptance and Adverse Events of the 2009 H1N1 Vaccination in Immunosuppressed Pediatric Liver Transplant Recipients

Cited by 18 publications

References 11 publications

Immunogenicity of pandemic influenza A H1N1/2009 adjuvanted vaccine in pediatric solid organ transplant recipients

Immunogenicity of pandemic influenza A H1N1/2009 adjuvanted vaccine in pediatric solid organ transplant recipients

Vaccination of immunocompromised patients

Adjuvanted (AS03) A/H1N1 2009 Pandemic Influenza Vaccines and Solid Organ Transplant Rejection: Systematic Signal Evaluation and Lessons Learnt

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