Preface

The CDC Anthrax Vaccine Safety & Efficacy Research Plan (The Plan) outlines studies and activities developed by CDC to address recent concerns that have been raised about the efficacy, safety, and to some extent, the acceptability of Anthrax Vaccine Adsorbed (AVA). The development and implementation of this plan is a direct response to U.S. House/Senate Conference Appropriations Language for FY001 and FY01.2 The Plan describes how CDC and its collaborators, including National Institutes of Health (NIH), Department of Defense (DoD), academic research centers, nongovernmental organizations, and private sector research organizations are responding to the Congressional charge to evaluate and improve the safety and efficacy of AVA. In one major component of this research, CDC’s National Center for Infectious Diseases (NCID) and National Immunization Program (NIP) are collaborating on an AVA clinical trial due to begin enrollment in March 2002. The interim results of data collected through subjects’ first 7 months of the study will be presented to the FDA for consideration of changing the route of AVA administration from SQ to IM, and elimination of the 2-week vaccine dose. At the end of the study, the entire results will be submitted to FDA for consideration of elimination of additional doses from the licensed AVA schedule. At that time, CDC will also supplement these data with results from parallel non-human primate challenge studies and additional research on immunologic correlates of protection. The CDC investigators will also evaluate the occurrence of local adverse events following AVA administration and the effect of selected risk factors, including gender on vaccine safety. CDC also is coordinating several activities to evaluate and improve adverse event reporting, evaluation, and management. As part of this activity, CDC and DoD are establishing a network of Vaccine Healthcare Centers (VHCs) of excellence within the military that will serve as a platform from which to conduct AVA safety research studies to enhance AVA’s safety, efficacy and acceptability. The DoD role is to focus on the clinical management and follow-up of service personnel with vaccine associated adverse events and the CDC role is to evaluate the VHC network’s impact, assess interventions and conduct vaccine safety-related research through these centers. This CDC Anthrax Vaccine Safety & Efficacy Research Plan proposes in greater detail several AVA research studies and activities that address the U.S. Congressional mandate to investigate the safety, efficacy and acceptability of AVA among military and civilian populations.

1  

The FY2000 House/Senate Conference Appropriations Language specified that the funds be used to address “1) the risk factors for anthrax vaccine adverse events, including differences in rates of adverse events between men and women; 2) determining immunological correlates of protection and documenting anthrax vaccine efficacy; and 3) optimizing the anthrax vaccination schedule and administration to assure efficacy while minimizing the number of doses required and the occurrence of adverse events.”

2  

The FY 2001 House/Senate Conference Appropriations Language states “Regarding the anthrax vaccine study, the conferees understand that clinical studies will be greatly facilitated by the establishment of the vaccine healthcare network, with the first site located at Walter Reed Army Medical Center.”



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