Giuseppe
Emeritus
HIV Vaccine Trial Results ? An Opening for Further Research (N Engl J Med., editorial, extract, edited)
HIV Vaccine Trial Results ? An Opening for Further Research
Raphael Dolin, M.D.
[Full Free PDF available at NEJM.org]
HIV-AIDS has emerged as an enormous, worldwide public health problem over the past 25 years. An estimated 33 million persons are infected with human immunodeficiency virus type 1 (HIV-1), and more than 7000 new infections occur every day.1 Although major advances have been made in the treatment of HIV-1 infection and in certain behavioral approaches to the prevention of HIV infection, ultimately, control will most likely depend on the development and application of a safe and effective HIV vaccine.
Substantial effort is being expended to develop an HIV vaccine through a variety of approaches. 2 However, disappointing results have emerged from the only three large-scale efficacy trials previously carried out in humans.3-5 In this issue of the Journal, Rerks-Ngarm et al.6 report the results of a clinical trial of a vaccine regimen (ClinicalTrials.gov number, NCT00223080), describing the first findings of possible prevention of HIV-1 infection in humans. This is of potentially great importance to the field of HIV research.
The two analyses specified in the protocol, the intention-to-treat and per-protocol analyses, showed vaccine efficacies of 26.4% (P = 0.08) and 26.2% (P = 0.16), respectively. A modified intention-to-treat analysis, in which subjects who had HIV-1 infection at the time of randomization were excluded, showed a vaccine efficacy of 31.2% (P = 0.04).
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HIV Vaccine Trial Results ? An Opening for Further Research
Raphael Dolin, M.D.
[Full Free PDF available at NEJM.org]
HIV-AIDS has emerged as an enormous, worldwide public health problem over the past 25 years. An estimated 33 million persons are infected with human immunodeficiency virus type 1 (HIV-1), and more than 7000 new infections occur every day.1 Although major advances have been made in the treatment of HIV-1 infection and in certain behavioral approaches to the prevention of HIV infection, ultimately, control will most likely depend on the development and application of a safe and effective HIV vaccine.
Substantial effort is being expended to develop an HIV vaccine through a variety of approaches. 2 However, disappointing results have emerged from the only three large-scale efficacy trials previously carried out in humans.3-5 In this issue of the Journal, Rerks-Ngarm et al.6 report the results of a clinical trial of a vaccine regimen (ClinicalTrials.gov number, NCT00223080), describing the first findings of possible prevention of HIV-1 infection in humans. This is of potentially great importance to the field of HIV research.
The two analyses specified in the protocol, the intention-to-treat and per-protocol analyses, showed vaccine efficacies of 26.4% (P = 0.08) and 26.2% (P = 0.16), respectively. A modified intention-to-treat analysis, in which subjects who had HIV-1 infection at the time of randomization were excluded, showed a vaccine efficacy of 31.2% (P = 0.04).
(...)
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