INTRODUCTION

The reports included in this document summarize the past and ongoing activities of the AIDS Vaccine Evaluation Group (AVEG). This introductory section includes an overview of the AVEG and its major functional units: AIDS Vaccine Evaluation Units, Data Coordinating and Analysis Center, Central Immunology Laboratory, and Mucosal Immunology Laboratory. AVEG activities are conducted under contract and active coordination with the Clinical Development Branch of the Division of AIDS of the National Institute of Allergy and Infectious Diseases. This section contains a listing of all AVEG studies, including the dates of active enrollment, a table of AIDS vaccine candidates studied by the AVEG, and provides an overview of the AVEG's structure.

Subsequent sections comprising the body of this report are:

• IMMUNOLOGY
  • Provides definitions for the immunogenicity assays performed
  • Describes the algorithms employed to screen samples for activity
  • Lists: Antigens and mitogens for lymphoproliferative studies
    • CTL assays
    • Antigens/peptides for ELISA assays
    • Specimen types for mucosal assays

• PROTOCOL OUTLINES

  Outlines are provided for completed and current AVEG studies. More detailed product descriptions of candidate vaccines are given in Appendix A; the AVEG standard inclusion/exclusion criteria are contained in Appendix B; the AVEG definition of risk criteria are provided in Appendix C.

• PARTICIPANT LISTINGS

• AVEG BIBLIOGRAPHY

SPECIAL NOTE: Sponsor names used throughout this handbook reflect product information found in AVEG protocol documents. Although some manufacturer/company names have changed, their current titles do not necessarily apply to those products tested in the protocols. [See Section IV for list of name changes.]