Clinical Immunization Safety Assessment (CISA) Network Priority Studies

The following list is a summary of CISA Network studies.

• Serious Adverse Events Following Yellow Fever Vaccine Administration
• Genetics of Guillain-Barré Syndrome (GBS)
• Live Vaccines in Children with DiGeorge Syndrome
• Smallpox Vaccination and Myopericardial Injury or Inflammation
• Hypersensitivity Algorithm
• Gelatin Case-Control Study
• Post-Immunization Adverse Event Registry
• Yellow Fever Telewatch
• Variable Immune Response after Influenza Vaccination in Children
• Family History Risk Study of Siblings

Serious Adverse Events Following Yellow Fever Vaccine Administration

The risk of acquiring yellow fever for United States travelers is often comparable to the risk of severe adverse events from the vaccine. This clinical evaluation of patients with serious adverse events following yellow fever vaccine administration, including risk assessment, aims to—

• Identify genetic risk factors for severe adverse events, particularly viscerotropic illness following yellow fever vaccine.
• Develop further evidence-based recommendations for use of yellow fever vaccine for travel abroad.

Genetics of Guillain-Barré Syndrome (GBS)

Guillain Barré syndrome (GBS) is the most common acute paralytic disease in the U.S. and has been associated with vaccination. This investigation of vaccine-associated and non-vaccine associated GBS aims to identify—

• Candidate genes that may be associated with increased risk of GBS following vaccination.
• Genes that may be specifically associated with an increased risk of GBS following immunization as compared with GBS not associated with vaccine.
• Cases of GBS that are temporally related to immunization and to evaluate the clinical features and the frequency of antecedent illnesses and concurrent infections with known GBS pathogens as demonstrated by serology and other methods.

Live Vaccines in Children with DiGeorge Syndrome

DiGeorge syndrome (DGS) causes varying degrees of immunosuppression in affected individuals. Few guidelines exist regarding use of live viral vaccines (LVV) in patients with DGS. This project aims to—

• Determine if patients with DGS who received LVVs experienced vaccine-related adverse events at rates higher than the general population.
• Determine if patients with DGS who did not receive LVVs experienced vaccine-preventable infections.
• Describe patients with DGS who received LVVs and those who did not.

Smallpox Vaccination and Myopericardial Injury or Inflammation

The smallpox vaccination program is considered essential to the national and military defense strategy against the bioweapons threat. This project aims to—

• Determine the rate of symptomatic or asymptomatic myopericarditis within 30 days after smallpox vaccination.
• Assess genetic, immune, or inflammatory markers in those who experience myopericarditis so vaccination guidelines for smallpox can be refined.

Hypersensitivity Algorithm

Hypersensitivity reactions to vaccine components are a frequent concern of vaccine providers and recipients, and the fear of such reactions may cause people to forgo certain vaccinations. This project aims to—

• Provide guidance and standardized procedures for the assessment of patients who may have experienced immediate hypersensitivity reactions following an immunization.
• Help determine the vaccine components responsible for hypersensitivity reactions.
• Provide protocols for use by physicians skilled in allergy skin testing to evaluate patients who have experienced suspected or proven hypersensitivity reactions following immunizations.

Gelatin Case-Control Study

Gelatin allergy can cause anaphylactic reactions when gelatin is introduced into a sensitive person. Immediate hypersenstivitiy reactions following receipt of gelatin-containing vaccines has been associated with elevated levels of gelatin-specific IgE. This project aims to—

• Determine the proportion of persons with immediate hypersensitivity reactions following gelatin-containing vaccines who have serum IgE antibody to gelatin, and compare the results with controls.
• Help develop evidence-based recommendations for vaccination of persons with elevated levels of gelatin-specific IgE.

Post-Immunization Adverse Event Registry

Because many adverse events (AEs) following immunization are rare, biological samples and clinical data from individuals who experience them should be collected as the events occur. This project aims to—

• Develop a registry of clinically significant AEs and related clinical data and a repository of biological specimens from patients who have experienced serious post-vaccination AEs for use in future studies.
• Increase our understanding of adverse responses to vaccines and guide development of re-immunization guidelines for patients who might benefit from further vaccinations, but may be at higher risk for AEs.

Yellow Fever Telewatch

Monitoring post-vaccination adverse events for large populations can be time- and resource-consuming. This project aims to determine—

• The effectiveness of an automated telephone and Web-based system for monitoring adverse events following vaccination.
• The rates of adverse events associated with yellow fever vaccination.
• The risk factors for increased rates of adverse events associated with yellow fever vaccination.

Variable Immune Response after Influenza Vaccination in Children

Seasonal influenza vaccine is recommended for children 6 to 59 months of age, yet some develop clinically significant adverse events including wheezing and other airway adverse events. This project aims to provide—

• A better understanding of the genetics of wheezing after influenza vaccination.
• A better understanding of the genetic variants associated with acquisition of influenza disease.
• Evidence-based recommendations for vaccinating children at risk of wheezing.

Family History Risk Study of Siblings

If genetic factors influence individual susceptibility to adverse events following immunization, then it follows that adverse events following immunization may aggregate within a family. This project aims to—

• Compare the risk of adverse events following vaccination in children with a family history of autoimmune or atopic disease to children without such a family history.
• Help develop evidence-based recommendations for vaccination in children with a family history of autoimmune or atopic disease.