2008
DOI: 10.1016/s0140-6736(08)61591-3
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Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial

Abstract: Background-Observational data and non-human primate challenge studies suggest that cellmediated immune (CMI) responses may provide control of HIV replication. The Step Study is the first direct assessment of the efficacy of a CMI vaccine to protect against HIV infection or alter early plasma HIV levels in humans.

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Cited by 1,561 publications
(1,540 citation statements)
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References 49 publications
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“…Education, identification and treatment of infected persons with antiretroviral drugs, male circumcision, condoms, and needle exchange programs have been effective at curtailing the epidemic, but declines in the rate of new infections have plateaued, and it appears unlikely that the goal of <500 000 new adult infections per year will be achieved by 2020. An effective HIV‐1 vaccine could contribute to further reductions of infections as part of a coordinated prevention strategy,2 but to date, testing of candidate vaccines in efficacy trials has been disappointing 3, 4, 5, 6, 7 with only one trial showing any degree of vaccine efficacy 8…”
Section: Introductionmentioning
confidence: 99%
“…Education, identification and treatment of infected persons with antiretroviral drugs, male circumcision, condoms, and needle exchange programs have been effective at curtailing the epidemic, but declines in the rate of new infections have plateaued, and it appears unlikely that the goal of <500 000 new adult infections per year will be achieved by 2020. An effective HIV‐1 vaccine could contribute to further reductions of infections as part of a coordinated prevention strategy,2 but to date, testing of candidate vaccines in efficacy trials has been disappointing 3, 4, 5, 6, 7 with only one trial showing any degree of vaccine efficacy 8…”
Section: Introductionmentioning
confidence: 99%
“…Risk did not seem to be increased in men who were both circumcised and Ad5 seronegative (HR 0.7, 95 % CI 0.3-1.4). These results did not change significantly on multivariate analysis using adjusted HRs (Buchbinder et al, 2008).…”
Section: Preventative Hiv Vaccine Trials In the Oecd Countriesmentioning
confidence: 66%
“…This clinical trial was stopped in September 2007, as there was a statistically significant increase in HIV acquisition in the vaccinated group, compared with the placebo group, in those who were uncircumcised (Buchbinder et al, 2008). The two factors responsible for the higher rate of HIV acquisition in the vaccinated group compared with the placebo group were circumcision status in male participants and exposure to the Ad5 vector used in the STEP study (Buchbinder et al, 2008). The unadjusted hazard ratio (HR) for risk of HIV-1 acquisition was highest in men who were uncircumcised and who were Ad5 seropositive [HR 3.9, 95 % confidence interval (CI) 1.3-11.9].…”
Section: Preventative Hiv Vaccine Trials In the Oecd Countriesmentioning
confidence: 99%
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“…The Ad5 vectored vaccines used in these trials may even have enhanced HIV‐1 infection rates 29, 30. Despite these early setbacks, there are several reasons for renewed optimism regarding the value of T‐cell approaches, in both preventative and therapeutic settings.…”
Section: T‐cell Vaccine Design Strategiesmentioning
confidence: 99%