Statistical evaluation of HIV vaccines in early clinical trials

Contemp Clin Trials. 2006 Apr;27(2):147-60. doi: 10.1016/j.cct.2005.11.008. Epub 2006 Jan 19.

Abstract

The HIV pandemic is a pressing threat to global public health; HIV vaccine development is critical. Clinical evaluation of HIV vaccine candidates differs from the standard therapeutics trial framework primarily due to the fact that healthy individuals are studied. We present an early stage evaluation program developed for the HIV Vaccine Trials Network (HVTN) motivated by characteristics unique to the vaccine setting. The program consists of 3 prototypical stages (Phase I, Ib, II) that provide a unified yet flexible approach to the safety and immunogenicity evaluation of diverse vaccine regimens. The goal of these early trials is to narrow the number of candidate vaccines to the most promising candidates worthy of further study in efficacy trials.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • AIDS Vaccines / immunology
  • AIDS Vaccines / therapeutic use*
  • Clinical Trials, Phase I as Topic / methods*
  • Clinical Trials, Phase II as Topic / methods*
  • Data Interpretation, Statistical*
  • Enzyme-Linked Immunosorbent Assay / methods
  • HIV Antibodies / blood
  • HIV Infections / prevention & control
  • HIV-1 / immunology
  • Humans
  • T-Lymphocytes / immunology

Substances

  • AIDS Vaccines
  • HIV Antibodies