Vaccine
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Conference proceedings, although an importance source to learn about new interventions, are brief and not subject to external evaluation prior to publication. Studies in human medicine suggest that trial results from conference proceedings may be poorly reported. The primary objective of this study was to evaluate characteristics of veterinary vaccine studies published in conference proceedings. 154 cattle or swine vaccine trials presented at veterinary practitioner conferences held in the United States from 1988 to 2003 were the test base to evaluate the following: abstract-to-publication ratio, positive-outcome ratios, differences between proceeding and subsequent journal articles, and compliance with the CONSORT Statement extension for abstracts. ⋯ Fewer than 10% of conference proceedings included: identification of the trials as randomized in the title, study design as field or challenge; the primary outcome; trial status; results for primary outcome; information about harms and funding source (2/89). When conference proceedings are subsequently published in journals; there is no significant difference in the data, however subsequent publication is uncommon. For many conference proceedings it would be difficult to assess the internal and external validity of the trial based on the information reported.
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Acute respiratory illnesses (ARI), comprising influenza-like illness (ILI) and other wintertime respiratory illnesses (ORI), impose substantial health and economic burdens on the United States. Little is known about the impact of ILI among household members (HHM), particularly children, on employees' productivity. To quantify the impact of employee and HHM-ILI and ARI on employee productivity, a prospective, observational cohort study was conducted among employees from three large US companies. ⋯ HHM illnesses accounted for 17.7% (1389/7868 days) of employee absenteeism, over half of which was due to HHM-ARI. ILI causes a significant amount of employee absence. Household members, particularly children, comprise a sizable proportion of general illness and injury-related employee absences.
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Serum bactericidal activity using human complement is the basis for established correlates of protection against invasive meningococcal disease. During the development of multicomponent protein-based vaccines against meningococcus B, it is necessary to measure antigen-specific bactericidal responses. ⋯ We characterized a large panel of strains and, using a competitive inhibition SBA, we identified four strains that are each specifically killed by bactericidal antibodies to one of the major vaccine components. These strains provide a straightforward approach to demonstrate protective responses to each component of the vaccine and demonstrate that each of the antigens in the vaccine is sufficient to provide a potentially protective level of bactericidal activity.
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GARDASIL has been shown to reduce the incidence of pre-cancerous cervical, vulvar, and vaginal lesions, and external genital warts causally related to HPV6/11/16/18. Because of its expected public health benefit on reduction of cervical cancer and other HPV-related diseases, this vaccine has been rapidly implemented in the routine vaccination programs of several countries. ⋯ These studies address general safety, including autoimmune disorders, long-term effectiveness, and type replacement. A summary of the surveillance efforts of the Unites States Centers for Disease Control and Prevention can be found in the accompanying article by Markowitz et al.
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Post-licensure evaluation of vaccines plays an important role in monitoring the progress of immunization programs, demonstrating population impact of vaccines, and providing data for ongoing policy decisions. Two human papillomovirus (HPV) vaccines are licensed and recommended for use in females in the United States, a quadrivalent human HPV vaccine, licensed in 2006 and a bivalent vaccine HPV vaccine licensed in 2009. HPV vaccination is recommended for females 11 or 12 years of age with catch-up vaccination through age 26 years. ⋯ While there are well established cancer registries in the United States, it will take decades before the impact of vaccine on cervical cancer is observed. More proximal measures of vaccine impact include outcomes such as prevalence of HPV vaccine types, incidence of cervical precancers and genital warts. We review systems in place or being established for post-licensure monitoring of HPV vaccine in the United States.