Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons

<p>Abstract</p> <p>Background</p> <p>Seasonal influenza imposes a substantial personal morbidity and societal cost burden. Vaccination is the major strategy for influenza prevention; however, because antigenically drifted influenza A and B viruses circulate annually, influenza vaccines must be updated to provide protection against the predicted prevalent strains for the next influenza season. The aim of this study was to assess the efficacy, safety, reactogenicity, and immunogenicity of a trivalent inactivated split virion influenza vaccine (TIV) in healthy adults over two influenza seasons in the US.</p> <p>Methods</p> <p>The primary endpoint of this double-blind, randomized study was the average efficacy of TIV versus placebo for the prevention of vaccine-matched, culture-confirmed influenza (VMCCI) across the 2005-2006 and 2006-2007 influenza seasons. Secondary endpoints included the prevention of laboratory-confirmed (defined by culture and/or serology) influenza, as well as safety, reactogenicity, immunogenicity, and consistency between three consecutive vaccine lots. Participants were assessed actively during both influenza seasons, and nasopharyngeal swabs were collected for viral culture from individuals with influenza-like illness. Blood specimens were obtained for serology one month after vaccination and at the end of each influenza season's surveillance period.</p> <p>Results</p> <p>Although the point estimate for efficacy in the prevention of all laboratory-confirmed influenza was 63.2% (97.5% confidence interval [CI] lower bound of 48.2%), the point estimate for the primary endpoint, efficacy of TIV against VMCCI across both influenza seasons, was 46.3% with a 97.5% CI lower bound of 9.8%. This did not satisfy the pre-specified success criterion of a one-sided 97.5% CI lower bound of >35% for vaccine efficacy. The VMCCI attack rates were very low overall at 0.6% and 1.2% in the TIV and placebo groups, respectively. Apart from a mismatch for influenza B virus lineage in 2005-2006, there was a good match between TIV and the circulating strains. TIV was highly immunogenic, and immune responses were consistent between three different TIV lots. The most common reactogenicity events and spontaneous adverse events were associated with the injection site, and were mild in severity.</p> <p>Conclusions</p> <p>Despite a good immune response, and an average efficacy over two influenza seasons against laboratory-confirmed influenza of 63.2%, the pre-specified target (lower one-sided 97.5% confidence bound for efficacy > 35%) for the primary efficacy endpoint, the prevention of VMCCI, was not met. However, the results should be interpreted with caution in view of the very low attack rates we observed at the study sites in the 2005-2006 and 2006-2007, which corresponded to relatively mild influenza seasons in the US. Overall, the results showed that TIV has an acceptable safety profile and offered clinical benefit that exceeded risk.</p> <p>Trial registration</p> <p>NCT00216242</p

Sport, genetics and the `natural athlete': The resurgence of racial science

This article explores the ethical implications of recent discussions that naturalize the relationship between race, the body and sport within the frame of genetic science. Many suggestions of a racially distributed genetic basis for athletic ability and performance are strategically posited as a resounding critique of the `politically correct' meta-narratives of established sociological and anthropological forms of explanation that emphasize the social and cultural construction of race. I argue that this use of genetic science in order to describe and explain common-sense impressions of racial physiology and sporting ability is founded on erroneous premises of objectivity and disinterest, and inflates the analytical efficacy of scientific truth claims. I suggest that assertions of a value-free science of racial athletic ability reify race as inherited permanent biological characteristics that produce social hierarchies and are more characteristic of a longer history of `racial science'

Testosterone dreams: rejuvenation, aphrodisia, doping

John Hoberman.381 p. ; 23 cm

Book Symposium: Ask Vest Christiansen's Gym Culture, Identity and Performance-Enhancing Drugs

This is a review and discussion of Ask Vest Christiansen’s book Gym Culture, Identity and Performance-Enhancing Drugs: Tracing a Typology of Steroid Use (2020). As indicated by the title, the book is on gym culture, the pursuit of fit, muscular bodies and the use of drugs as a means to get there. The book builds on the international research literature and in-depth interviews with men who have experience of image and performance enhancing drugs (IPEDs), to explore the fascination with muscles, motivations for using drugs to enhance them, assessments of risk and experience of side effects. The book examines what the altered body does to the men’s identity, self-image and relationships with peers and partners. Taking an evolutionary psychological approach, it also investigates the biological and psychological foundations of the fascination with the muscular body. Moreover, the book considers the political and regulatory frameworks in place to prevent the use of IPEDs and assess those strategies potential to reach their aims

Promoting the Ostjuden: Ethnic identity, stereotyping, and audience in the German-Jewish cultural review "Ost und West" (Berlin, 1901-1923)

Between 1901 and 1923, the Berlin-based cultural journal Ost und West promoted East European Jewish culture to a fairly assimilated Jewish audience in Central Europe. The common goal of its editors was to reverse Jewish assimilation in "the West" by promoting "Eastern" models for Jewish identity. East European Jews ("Eastern Jews" or Ostjuden) had been perceived negatively by many Western Jews (Westjuden) and non-Jews since the Enlightenment. Since that time, intellectuals and policymakers had sought to "dejudaize" the Ostjuden to make them more like good "Europeans." To combat this program of Westernization, Ost und West attempted to create a positive image of Eastern Jews and to legitimize public expressions of "Jewishness" in the West.Yet Ost und West did not merely "repackage" the Eastern Jew in order to make Jewishness attractive. Instead, its editors often published negative images of Westernized Jews in reaching out to its mainly German-Jewish readership. Negative stereotypes of Ostjuden were taken and grafted onto representations of Westjuden. These "new" stereotypes were then used to address three Jewish audiences in Germany: intellectuals, middle-class women, and middle-class men. Each audience is the subject of a specific chapter of the dissertation.The idea that Jews eagerly assimilated to German society and that they were self-hating is subjected to critical scrutiny in this study. After World War I ended, increasing anti-Semitism and inflation brought on Ost und West's decline. Nevertheless, the journal had already influenced other periodicals to focus on Ostjuden, and its ethnic definitions of Jewishness were increasingly adopted as a model for German-Jewish identity. The study of Ost und West ultimately extends our knowledge of how minority groups understand themselves. It also illuminates contemporary discussions in Europe and the Americas regarding ethnic identity.Thesis (Ph.D.)--The University of Texas at Austin, 1993.School code: 0227