Comparison of requirements in the European Union and United States of America for pre-clinical viral safety testing of veterinary vaccines.

Of paramount importance in ensuring the safety of live and inactivated veterinary vaccines is demonstration of freedom from extraneous agents in biological starting materials used in their production. Both the European Union (EU) and United States of America (US) provide regulations and guidelines on extraneous agent testing of veterinary vaccines including guidance from the Committee for Medicinal Products for Veterinary Use (CVMP), the European Pharmacopoeia (Ph. Eur.) and the USDA Code of Federal Regulations, Title 9 (9CFR). There are distinct requirements prescribed in EU and US regulations and guidelines. The differences in EU and US requirements for extraneous agent testing of starting materials are such that there may be occasions when no one test may satisfy both sets of regulations for a given scenario. For compliance with both, for global licensing purposes it may therefore be necessary to perform additional tests and/or to justify methods chosen from one set of regulations over another, based on a variety of factors.

Sexually transmitted infections and prostate cancer among men in the U.S. military.

Studies of self-reported sexually transmitted infections (STI) suggesting an association with prostate cancer may reflect underreporting of such infections among nondiseased subjects. To reduce such bias, we studied archived sera in a cohort of U.S. military personnel known to have high rates of both STIs and prostate cancer. Using a nested case-control design, serum samples from 534 men who served on active duty between September 1, 1993 and September 1, 2003 were examined. Controls were individually matched to cases based on date of serum collection, date of birth, branch of service, military rank, marital status, and race. Each of the 267 case-control pairs had two serum samples: a recent serum sample, taken approximately 1 year before the case's prostate cancer diagnosis, and an earlier serum sample, taken approximately 8 years before diagnosis. Each serum specimen was studied for antibodies against human papillomavirus, herpes simplex virus-2 (HSV-2), and Chlamydia trachomatis. Logistic regression accounted for matching and potential confounding factors. Study data indicated no association between prostate cancer and serologic evidence of infections just before the reference date. However, a statistically significant association between prostate cancer and serologic evidence of HSV-2 infection was detected in the earlier sample (odds ratio, 1.60; 95% confidence interval, 1.05-2.44). The strength of this association increased when analyses were restricted to sera collected at least 60 months before diagnosis (odds ratio, 2.04; 95% confidence interval, 1.26-3.29; 204 pairs). If this association is causal, then our findings would suggest a long latency period for prostate cancer development after HSV-2 infection.

Sunburns and risk of cutaneous melanoma: does age matter? A comprehensive meta-analysis.

PURPOSE: Sunburns are an important risk factor for melanoma and those occurring in childhood are often cited as posing the greatest risk. We conducted a meta-analysis to quantify the magnitude of association for melanoma and sunburns during childhood, adolescence, adulthood and over a lifetime. METHODS: After reviewing over 1300 article titles and evaluating 270 articles in detail, we pooled odds ratios from 51 independent study populations for "ever" sunburned and risk of cutaneous melanoma. Among these, 26 studies reported results from dose-response analyses. Dose-response analyses were examined using both fixed-effects models and Bayesian random-effects models. RESULTS: An increased risk of melanoma was seen with increasing number of sunburns for all time-periods (childhood, adolescence, adulthood, and lifetime). In an attempt to understand how risk between life-periods compares, we also report these same linear models on a scale of five sunburns per decade for each life-period. The magnitude of risk for five sunburns per decade is highest for adult and lifetime sunburns. CONCLUSIONS: Overall, these results show an increased risk of melanoma with increasing number of sunburns during all life-periods, not just childhood. Prevention efforts should focus on reducing sunburns during all life-periods.