well as the prioritization CDC assigned to each study, is presented in three matrices (Tables 3-1, 3-2, 3-3). This chapter summarizes the studies that CDC has planned to address each set of research objectives. More detailed descriptions of the studies and the committee’s review of each study are provided in Chapters 4, 5, and 6 of this report. The committee’s overall assessment of the research plan is presented in Chapter 7.

The research studies are being carried out or managed at CDC by two units—the National Immunization Program (NIP) and the National Center for Infectious Diseases (NCID). As its name suggests, NIP is a disease-prevention program providing for the planning, coordination, and conduct of immunization activities nationwide (CDC, 2001). Its activities include providing consultation and training to assist health departments in planning, developing, and implementing immunization programs; administering research and operational programs for prevention and control of vaccine-preventable diseases; and supporting a nationwide framework for surveillance of vaccine-preventable diseases. NIP’s support to health departments includes assistance in developing information management systems to monitor the safety and efficacy of vaccines by linking vaccine administration information with adverse event reporting and disease outbreak patterns (CDC, 2001). In keeping with these activities, the aspects of the anthrax safety and efficacy research program developed and overseen by NIP include studies of vaccine acceptability as well as of the use of data from the Vaccine Adverse Event Reporting System (VAERS) and the Defense Medical Surveillance System (DMSS) to improve information about adverse events following vaccination.

NCID is focused on the prevention of disease, disability, and death caused by infectious diseases and seeks to accomplish this goal by working with public health officials, health care professionals, and international groups (CDC, 2002a). The center’s staff conducts surveillance, epidemic investigations, epidemiologic and laboratory research, training, and public education programs to develop and promote prevention and control strategies for infectious diseases. For the anthrax vaccine research program, NCID has developed and is managing three interrelated studies of the safety and efficacy or immunogenicity of the vaccine in both humans and nonhuman primates (NHPs).

The following sections review the research objectives and critical research questions described in the CDC materials.

EFFICACY

CDC’s stated objectives for the efficacy component of its anthrax vaccine research program are displayed in Box 3-1.

The studies that have been planned to address efficacy and immunogenicity are (1) the Human Reactogenicity and Immunogenicity Trial (the Human Clinical Trial); (2) the Nonhuman Primate Vaccine Dose Ranging, Immunogenicity, and Challenge Trial (the NHP study); and (3) the Correlates of Protection Study (the ICP study). These studies are being carried out at or through NCID.

BOX 3-1 CDC Objectives for Research on the Efficacy of the Anthrax Vaccine

  1. Assess AVA efficacy in humans immunized with AVA by measuring immune responses identified as protective in efficacy objective B (animal studies). Immune markers of protection will be evaluated by varying the number of priming shots and the route of administration.

  2. Assess AVA efficacy in animals immunized with serial dilutions of AVA and challenged with live, inhaled anthrax spores.

  3. Use blood samples from the subjects in the clinical trial and in animal studies to identify immune correlates of protection and validate laboratory studies to measure them.

SOURCE: CDC, 2002c, p. 10.



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