Document 0298
 DOCN  M9550298
 TI    Some statistical issues in HIV vaccine trials.
 DT    9505
 AU    Rida WN; Lawrence DN; Biostatistics Research Branch, National Institute
       of Allergy and; Infectious Diseases, Bethesda, MD 20892.
 SO    Stat Med. 1994 Oct 15-30;13(19-20):2155-77. Unique Identifier : AIDSLINE
       MED/95149009
 AB    Efficacy trials of prophylactic HIV vaccines will be among the most
       difficult clinical trials ever attempted. Not only will there be
       challenges with the recruitment and retention of high-risk uninfected
       individuals, there will be many statistical challenges to the design,
       conduct, analysis, and interpretation of these trials. General features
       of an efficacy trial are described, including choice for the primary
       endpoint and testing for and estimating vaccine efficacy. Secondary
       objectives of trials are also discussed. These include determining the
       correlates of protective immunity, assessing the impact of HIV genetic
       variation on vaccine efficacy, and using biological markers such as
       viral load and CD4+ lymphocyte cell count to gain insight on a vaccine's
       ability to prevent or delay disease. The use of biological markers as
       surrogates for disease outcome is discussed. Last, trial designs for
       studying several candidate vaccines or other HIV prevention strategies
       in a single trial are examined.
 DE    Acquired Immunodeficiency Syndrome/*PREVENTION & CONTROL  Adult  Animal
       *AIDS Vaccines/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/
       CLASSIFICATION/GENETICS/IMMUNOLOGY/PHARMACOLOGY/THERAPEUTIC USE
       Biological Markers  Chimpansee troglodytes  *Clinical Trials  Clinical
       Trials, Phase I  Cohort Studies  CD4-Positive T-Lymphocytes/IMMUNOLOGY
       Disease Models, Animal  Disease Transmission, Vertical  Ethics  Female
       Homosexuality, Male  Human  HIV
       Infections/DIAGNOSIS/EPIDEMIOLOGY/*PREVENTION & CONTROL/  TRANSMISSION
       HIV Seropositivity/DIAGNOSIS  HIV-1/GENETICS  Infant  Macaca mulatta
       Male  Prostitution  Randomized Controlled Trials/STATISTICS & NUMER DATA
       *Research Design  Sample Size  Time Factors  Treatment Outcome  JOURNAL
       ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).