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- Villa, Luisa L., et al.
(author)
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Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
- 2007
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In: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 356:19, s. 1915-1927
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Journal article (peer-reviewed)abstract
- BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18. METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18. RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31). CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group.
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| 2. |
- Stapleton, L M, et al.
(author)
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Microbial carbon dynamics in nitrogen amended Arctic tundra soil: Measurement and model testing
- 2005
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In: Soil Biology & Biochemistry. - : Elsevier BV. - 0038-0717. ; 37:11, s. 2088-2098
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Journal article (peer-reviewed)abstract
- We examined the responses of grazers (protozoa and nematodes) and their main food sources to low levels of nitrogen (N) fertilisation and applied carbon (C) flux models to our data. Replicate plots of tundra soil adjacent to the Kongsfjorden (Svalbard 78°N) were amended with ammonium and nitrate at concentrations of 1 and 5 kg N ha−1 to assess the impact of anthropogenic N deposition over three summers. Bacterial abundance as determined using the fluorochrome SYBR Green and epifluorescence microscopy ranged between 9.73×108 and 102.49×108 cells/g dry wt of soil, with a significant response to N addition occurring only during the second sampling in 2001. Despite little change in bacterial biomass, bacterial production (measured by the incorporation of 3H thymidine into DNA) during the second sampling in 2002, increased in NH4 enriched plots compared to control and NO3 amended plots, indicating that NH4 was the preferred source of inorganic N. The main bacterial predators were heterotrophic flagellates (HNAN) and naked amoebae, which showed no significant response to the N addition. HNAN showed a correlation with bacterial abundance suggesting a dependence on bacteria as a food source. The inability of a microbial C flux model to fit our data (RWSS/data=18.6, r2=0.088) was at least partly due to insufficient bacterial production to meet the C demands of predator taxa, and high variability in the data over time. This is reflected in the performance statistics for model variants where select microbial taxa and data were removed. The optimal model in terms of predictive utility was a model with data from 2002 only, minus naked amoebae (RWSS/data=2.45, r2=0.806).
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