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.

The vaccine was generally well tolerated and induced cell-mediated immune responses against human immunodeficiency virus type 1 peptides in most healthy adults. Despite these findings, vaccination in a proof-of-concept trial with use of this vaccine was discontinued because of lack of efficacy.

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BackgroundMicrobial exposures have been suggested to confer protection from allergic disorders and reduced exposures to gastrointestinal microbiota have been proposed as an explanation for the increase in asthma prevalence. Since the general prevalence of Helicobacter pylori has been decreasing, we hypothesized that H. pylori serostatus would be inversely related to the presence of asthma.MethodsAdults were recruited to participate in the New York University (NYU)/Bellevue Asthma Registry in New York City. Adult asthma cases (N = 318) and controls (N = 208) were identified and serum IgG antibodies to H. pylori whole cell antigens or the immunodominant CagA antigen were measured.ResultsAs expected, the asthma cases and controls differed with respect to atopy and lung function. Seropositivity to H. pylori or CagA antigen was present in 47.1% of the total case and control study population. Asthma was inversely associated with CagA seropositivity (OR = 0.57, 95% CI = 0.36–0.89). Median age of onset of asthma (doctor's diagnosis) was older (21 years) among individuals with CagA+ strains than among H. pylori- individuals (11 years) (p = 0.006).ConclusionThese data are consistent with the hypothesis that colonization with CagA+ H. pylori strains is inversely associated with asthma and is associated with an older age of asthma onset in an urban population. The data suggest H. pylori as a marker for protection.Trial RegistrationClinicalTrials.gov NCT00212537

To determine whether the ISNT rule (that normal eyes show a characteristic configuration for disc rim thickness of inferiorՆsuperiorՆnasalՆtemporal), widely used for clinical evaluation of the optic nerve head, can differentiate normal from glaucomatous eyes.Methods: All subjects underwent complete eye examination, including achromatic automated perimetry, simultaneous stereoscopic disc photography, and confocal scanning laser ophthalmoscopy. Subjects with normal eyes had no evidence of glaucoma or ocular hypertension and had normal perimetry measurements. Subjects with glaucoma had a reproducible visual field defect. One eye from each subject was randomly enrolled. The ISNT rule was assessed by masked evaluation of disc photographs at the 3, 6, 9, and 12 o'clock positions.Results: Sixty-six subjects with normal eyes (33 black and 33 white individuals) and 43 with open-angle glaucoma (15 black and 28 white individuals) were enrolled. The ISNT rule was intact in 52 (79%) of 66 normal eyes and 12 (28%) of 43 glaucomatous eyes (PϽ.001). Multiple logistic regression indicated that the odds ratio for glaucoma associated with violation of the ISNT rule was 6.04 (95% confidence interval, 1.74-20.95) after adjustment for age; race was not a confounder of this association. Conclusion:The ISNT rule is useful in differentiating normal from glaucomatous optic nerves and is unaffected by race.

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It is likely that high-risk volunteers will be willing to enroll in HIV vaccine efficacy trials. A variety of participant and community educational strategies are needed to address participant concerns, and to ensure understanding of key concepts prior to giving consent for participation.