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Human immunodeficiency virus vaccine development in developing countries: are efficacy trials feasible?

Publication ,  Journal Article
Excler, JL; Beyrer, C
Published in: J Hum Virol
2000

The implementation of human immunodeficiency virus (HIV) vaccine efficacy trials in developing countries represents an unprecedented series of challenges for the medical and scientific communities, health authorities, policy makers, and the populations of diverse countries. Such trials require great attention, dedication, and information at the earliest possible time from many groups in these communities, as well as the clear and full collaboration of all the national and international institutions and agencies involved. This article discusses suggestions and makes recommendations regarding multiple hurdles to trial implementation, including access to appropriate populations, incidence and natural history of HRV type 1 (HIV-1) infection, definition of efficacy endpoints, and logistical, ethical, regulatory, political, and media issues. The conduct of phase I and II trials in developing countries will be a critical step for appropriate vaccine selection and in helping to identify the country- and community-specific issues and the needs for further implementation. Some countries have already established their own national HIV vaccine development plans. Additional operational and action plans with special emphasis on efficacy trial implementation would be strongly recommended after country-specific preparedness workshops and constitution of national or regional task forces.

Duke Scholars

Published In

J Hum Virol

ISSN

1090-9508

Publication Date

2000

Volume

3

Issue

4

Start / End Page

193 / 214

Location

United States

Related Subject Headings

  • Virology
  • Research Design
  • Politics
  • Patient Selection
  • Incidence
  • Humans
  • HIV Infections
  • Developing Countries
  • Communications Media
  • Cohort Studies
 

Citation

APA
Chicago
ICMJE
MLA
NLM

Published In

J Hum Virol

ISSN

1090-9508

Publication Date

2000

Volume

3

Issue

4

Start / End Page

193 / 214

Location

United States

Related Subject Headings

  • Virology
  • Research Design
  • Politics
  • Patient Selection
  • Incidence
  • Humans
  • HIV Infections
  • Developing Countries
  • Communications Media
  • Cohort Studies