KEYWORDS:
Vaccine Safety
Adverse Events
Expertise
clinical evaluation
network

BACKGROUND:
Clinical Immunization Safety Assessment (CISA) centers are a new initiative designed to improve the scientific understanding of vaccine safety issues at the individual "patient" level and will serve as a source of clinical expertise in adverse events following immunization.

OBJECTIVE(S):
· Develop clinical protocols for the evaluation and management of adverse events following immunization Evaluate patients with similar adverse events, using a standard protocol and assess genetic or other risk factors that predispose high-risk groups to adverse reactions
· Provide immunization guidelines and clinical management protocol for high-risk patients
> Serve as a public and provider regional referral center for clinical vaccine safety inquiries.

METHOD(S):
The CISA network will systematically evaluate cases of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). Selected cases will undergo enhanced follow up and targeted clinical evaluation, to better understand the mechanism and risk factors for the event. Health care providers will also be able to refer patients to a CISA center for a consultation, either by filing a VAERS report and including a specific request, or through usual consultation mechanisms already in place to specialists at the institutions with whom a center is affiliated. The results of these evaluations will be used to develop clinical evaluation protocols or patient management guidelines that can be used by all health care providers.


RESULT(S):
The initial launch of CISA centers was funded in October 2001 for a total $1.9 million and includes Johns Hopkins University, Northern California Kaiser, Boston University Medical Center and Columbia Presbyterian Hospital.

CONCLUSIONS(S):
It is anticipated that the CISA Network will produce some relevant clinical investigations regarding adverse events following immmunization.

LEARNING OBJECTIVES:
To introduce the Clinical Immunization Safety Assessment Network formation.
To understand how CISA interfaces with VAERS.
To introduce topics of study for the CISA network in the coming year.