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Clinical Immunization Safety Assessment (CISA) Network

The Clinical Immunization Safety Assessment (CISA) Network is a national network of six medical research centers with expertise in immunization safety conducting clinical research on immunization associated health risks. CISA was established in 2001 as a collaborative project between the Immunization Safety Office, six medical research centers, and America's Health Insurance Plans.

How does the CISA Network receive vaccine safety questions?

Vaccine safety questions come from a variety of sources, including CDC's information line (1-800-CDC-INFO), electronic mail, and calls to the Immunization Safety Office and CISA sites. While the CISA Network cannot address all vaccine safety concerns, it makes every effort to provide support for these important questions.

How does the CISA Network address complex vaccine safety questions?

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Experts in vaccinology and vaccine safety from the six academic medical centers convene a monthly conference call, during which a complex vaccine safety issue is addressed in a structured format. An investigator presents a case, which includes the history of present illness (the adverse event following vaccination), and detailed physical and diagnostic (laboratory and other) findings. A summary of a literature review on this subject and the Vaccine Adverse Event Reporting System (VAERS) data are also presented. The experts discuss the findings and formulate a general assessment and plan. When appropriate, these conclusions are shared with the concerned provider.

The CISA Network has published several scientific articles and is leading a genomics initiative to study the role of human genetic variations in vaccine safety.

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Mission

  • To conduct clinical research about vaccine adverse events (VAE) and the role of individual variation
  • To provide clinicians with vaccine-based counsel and empower individuals to make informed immunization decisions
  • To assist domestic and global vaccine safety policy makers in the recommendation of exclusion criteria for at-risk individuals
  • To enhance public confidence in sustaining immunization benefits for all populations

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CISA Network Sites

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Goals

  • To study the pathophysiologic basis of adverse events following immunization using hypothesis-driven protocols.
  • To study risk factors associated with developing an adverse event following immunization using hypothesis-driven protocols, including genetic host-risk factors.
  • To provide clinicians with evidence-based guidelines when evaluating adverse events following immunization.
  • To provide clinicians with evidence-based vaccination or revaccination guidelines.
  • To serve as a regional referral center to address complex vaccine safety inquiries.

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Peer Review

In December 2010, CDC convened an External Peer Review of the Division of Healthcare Quality Promotion (DHQP) Surveillance Branch, to assess the scientific contributions of CISA. The primary focus of this meeting was to determine how CISA Network goals fit within the public health mission of CDC and ISO. A report on CISA provides the key points from the discussions and recommendations from the External Peer Review. [PDF - 303 KB]

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