Clinical Immunization Safety Assessment (CISA) Network Priority Studies

Research Projects

• Genetics of Guillain-Barré Syndrome (GBS) Genome Wide Association Study (GWAS)

  The aims of this case control study include identifying genetic factors associated with GBS and GBS following immunization.
  Lead CISA Site: Boston University

• Retrospective Review of Post-Vaccination Adverse Events in Patients with Mitochondrial   Disorders

  The aims of this study include determining if patients with primary mitochondrial disorders who received immunizations experience health care encounters at higher rates than those reported in the general population. The study also aims to determine if patients with primary mitochondrial disorders are immunized with recommended vaccines at the same rates and ages as the general population.
  Lead CISA Site: Columbia University

• FeverText: Assessing Fever Rates after Influenza and Pneumococcal Vaccination Using Text Messaging During the US 2011-12 Influenza Season

  This study assesses the risk of fever in children who receive inactivated influenza and pneumococcal vaccines either separately or together. The study also aims to assess the utility and acceptability of text messaging to monitor a specific adverse event after vaccination.
  Lead CISA Site: Columbia University

• A Genome-Wide Association Study to Examine Genes Associated with an Increased Risk of Febrile Seizure in Children Following Measles-Containing Vaccines

  The objective of this case control study is to evaluate the human genome of individuals who experienced a febrile seizure 7 to 10 days after Measles-Mumps-Rubella (MMR) or Measles-Mumps-Rubella-Varicella (MMRV) vaccines in order to identify genetic risk factors associated with febrile seizures.
  Lead CISA Site: Kaiser Permanente Northern California

• Live Vaccines in Individuals with DiGeorge Syndrome (DGS)

  The primary aims of this study are:
  To examine potential adverse events in the 56 days following live vaccination in individuals with DGS.
  To assess the relationship between disease severity and potential live vaccine-related adverse events.
  Lead CISA Site: Columbia University

• Genetic Polymorphisms and Hypersensitivity Reactions to Vaccines

  The aims of this case-control study include evaluating the role of gelatin and other components in hypersensitivity reactions to vaccines and to identify the genetic basis of hypersensitivity reactions.
  Lead CISA Site: Johns Hopkins University

• A Self-Controlled Case Series study of Risk Factors for Idiopathic Acute Transverse Myelitis

  The aims of this study include understanding the vaccine related risk factors related to the onset of idiopathic acute transverse myelitis.
  Lead CISA Site: Johns Hopkins University   

• Testing for PCV1 and PCV2 DNA in Stools of RotaTeq Vaccines

  The goal of this study is to examine stool specimens of children vaccinated with RotaTeq vaccine in 2008-2009 for the presence of Porcine circovirus type 1 (PCV1) and Porcine circovirus type 2 (PCV2) DNA and look for evidence of viral replication in vaccines.
  Lead CISA Site: Columbia University

• Underimmunization with Diphtheria, Tetanus, and Acellular Pertussis (DTaP) Vaccine and Risk of Pertussis in an Outbreak Setting

  The aims of this study includes determining the strength of association between  DTaP  under immunization and risk of a pertussis PCR-positive test among children 6 months through 6 years of age in the Kaiser Permanente Northern California population. The study also aims to explore reasons for DTaP under immunization.
  Lead CISA Site: Kaiser Permanente Northern California

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Clinical Projects

• CISA Clinical Consult Case Review (CCCR) Working Group

  CISA provides expert panel reviews for individuals that have adverse events following immunization, which are deemed significant by healthcare providers.  Each case is systematically discussed using a clinical consult case review template.
  Lead CISA Site: Vanderbilt University

• CISA Hypersensitivity Review Working Group

  The hypersensitivity working group convenes monthly on CISA conference calls to discuss vaccine adverse events that appear to be hypersensitivity reactions.  Allergists discuss findings and create a general assessment and plan for individual cases, and also discuss suggested revisions to regulatory guidelines for vaccination.

  The Hypersensitivity Working Group also conducted a review of VAERS reports of hypersensitivity following the 2009-H1N1 influenza vaccine to characterize adverse events. 
  Lead CISA Site: Johns Hopkins University

• Biologically Plausible and Evidence-Based Risk Intervals in Immunization Safety Research

  CISA convened a working group to systematically assess and discuss biologically plausible periods of time during which vaccine recipients are thought to be at potentially increased risk of an adverse event following immunization. A goal was to provide information on biologically plausible risk intervals for use in future clinical and epidemiologic studies of immunization safety.
  Lead CISA Site: Kaiser Permanente Northern California

• Vaccine Safety Advice Network (VSAN) Pilot Project

  CISA is implementing a web-based pilot project to respond to health care questions regarding vaccine related adverse events or safety in Tennessee. This project involves a coordinated response between the Tennessee Department of Health (TNDOH) and the Vanderbilt Vaccine Research Program (VVRP).
  Lead CISA Site: Vanderbilt University

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