       Document 0075
 DOCN  M9620075
 TI    Assessing HIV vaccine effects.
 DT    9602
 AU    Koopman JS; Little RJ; Department of Epidemiology, University of
       Michigan, Ann Arbor; 48109-2029, USA.
 SO    Am J Epidemiol. 1995 Nov 15;142(10):1113-20. Unique Identifier :
       AIDSLINE MED/96066870
 AB    It is unlikely that human immunodeficiency virus (HIV) vaccines will
       create impenetrable barriers to infection. When the barriers to
       infection are broken, however, vaccine effects on the progression of
       infection to disease and on the contagiousness of infection could be
       considerable. The usual outcomes of vaccine trials are either infection
       or disease. The authors argue that for HIV vaccines, the alternative
       outcome of contagiousness may be more important. Because of the long
       incubation period to acquired immunodeficiency syndrome (AIDS), a
       vaccine trial with AIDS as the outcome would be a long and costly
       undertaking. Because contagiousness is concentrated into the period of
       primary infection, vaccine trials assessing contagiousness would not
       take as long. An approach to assessing vaccine effects on the
       contagiousness of primary infection while simultaneously assessing
       protection against infection is presented. It involves randomizing
       vaccination of couples in whom both individuals are uninfected and one
       or both have a risk of infection outside the couple. In such a study,
       the vaccine effect on susceptibility to infection can be estimated from
       the proportions of vaccinated and unvaccinated couples in whom neither
       partner is infected. Estimation of the contagiousness effect also uses
       information on the frequency with which both partners are infected. In
       areas of the world where heterosexual epidemics are emerging within the
       context of concurrent partnerships, the randomization of vaccination of
       couples could increase the efficiency and decrease the costs of vaccine
       trials.
 DE    *AIDS Vaccines  Confounding Factors (Epidemiology)  Disease
       Susceptibility/IMMUNOLOGY  Female  Human  HIV/PATHOGENICITY  Male
       *Models, Immunological  Randomized Controlled Trials  Virulence  JOURNAL
       ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
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