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HIV vaccine development and evaluation: realistic expectations

W L Heyward1, K M MacQueen, K L Goldenthal

  • 1Division of HIV/AIDS Prevention, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.

AIDS Research and Human Retroviruses
|November 14, 1998
PubMed
Summary
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Developing an effective human immunodeficiency virus (HIV) vaccine is progressing rapidly, with early trials underway. Further large-scale efficacy trials are anticipated to achieve a safe and effective HIV vaccine.

Area of Science:

  • Vaccinology
  • Immunology
  • Infectious Diseases

Background:

  • Over 85 vaccines for 24 indications were licensed in the US by January 1998.
  • Vaccine development typically requires many years from agent discovery to licensure.
  • Multiple efficacy trials are often necessary for vaccine approval.

Purpose of the Study:

  • To review the progress of human immunodeficiency virus (HIV) vaccine development.
  • To discuss the initiation and future plans for HIV vaccine efficacy trials.

Main Methods:

  • Review of ongoing and planned human immunodeficiency virus (HIV) vaccine trials.
  • Analysis of the decision-making process for advancing candidate vaccines to large-scale efficacy trials.

Main Results:

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  • Over 34 candidate HIV vaccines have undergone Phase 1 trials, with three advancing to Phase 2.
  • The first Phase 3 efficacy trial for an HIV vaccine has commenced in the US.
  • Three additional Phase 3 trials are planned within the next three years.

Conclusions:

  • Significant progress has been made in HIV vaccine development despite incomplete understanding of pathogenesis.
  • Future HIV vaccine development will likely involve numerous large-scale efficacy trials across diverse populations.
  • Phase 3 trials are crucial for advancing the development of a safe and effective HIV vaccine.