Clinical Immunization Safety Assessment

Clinical immunization safety assessment centers The National Immunization Program of the Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA, is trying to set up a network of Clinical Immunization Safety Assessment Centers (CISA). Based on standardized clinical evaluation protocols the centers will assist health care providers in evaluating patients who may have had an adverse reaction after immunization. Furthermore, the centers will evaluate newly hypothesized syndromes or events identified through the routine VAERS (28). 

Announcing funding for clinical immunization safety assessment centers. www.cdc.gov/od/pgo/funding/ 01112.htm, 27/06/2001. 

WHO adopted for their revised guidance, the terminology outlined by the Clinical Immunization Safety Assessment (CISA) Network. CISA had redefined terms used to describe causal relationship between vaccine and AEFI. They felt that using the terms consistent with, inconsistent with and indeterminate was favourable, compared to the previously used very likely/certain, probable, possible, unlikely, unrelated and unclassifiable, and would reduce confusion and inconsistency [3 ]. 

Regulatory guidance for the conduct of clinical trials on vaccines is specific. Traditional phase I trials in normal volunteers are not conducted. Rather, all trials assess not only safety but also efficacy (or at least immunogenicity). Trials may well be challenge trials, that is, after immunization subjects are purposely challenged with exposure to the infective agent of concern. 

In another clinical trial the immunogenicity and safety of polysaccharide vaccine has been assessed in 21 renal transplant recipients (15). Protective antibody titers were reached at 6 and 12 weeks after immunization in aU recipients, bar one. No local or systemic adverse effects were observed. 

The central aspect of clinical testing in infants should include the evaluation of a diverse spectrum of immune functions in response to an added substance. To develop the appropriate tests for assessing the safety of the immunological responses to new substances, it is useful to first identify the target tissues affected by the interaction of ingested substances with the host immune system (Table 6-7). 

As seen in the overview of the proposed clinical guidelines (Figures D-4, D-5, and D-6), it is not clear whether assessments of body composition, immune response, auditory function, and temperament were conducted. Several of these tests (to be determined by expert panels), applied at level 2 or level 3, are especially important to determine the safety of LC-PUFAs because theoretical safety concerns exist. For example, LC-PUFAs affect immune response, and they have been linked to neural development. Chapter 6 provides the committee s findings and recommendations on body composition and immune, auditory, and temperament assessment. 

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