Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 18-49 years of age, naive to 23-valent pneumococcal polysaccharide vaccine.

BACKGROUND: Based on the success of vaccination with pneumococcal conjugate vaccines (PCVs) in children, recent studies have focused on PCVs in adults. Data from a randomized, double-blind study comparing the immunogenicity, tolerability, and safety of the 13-valent PCV (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) in PPSV23-naive adults 60-64 years of age have been published. The same study also included a cohort of adults aged 18-49 years that received open-label PCV13. The purpose of this cohort was to examine the immunogenicity, safety, and tolerability of PCV13 in adult subjects 18-49 years of age compared with adults 60-64 years of age for whom PCV13 is approved. METHODS: Adults naive to PPSV23 were grouped by age into 2 cohorts: 18-49 years (n=899; further stratified by age into 3 subgroups 18-29, 30-39, and 40-49 years) and 60-64 years (n=417). All subjects received 1 dose of PCV13. In both age groups, immunogenicity was assessed by antipneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) and IgG geometric mean concentrations (GMCs) 1 month after vaccination. Safety and tolerability were evaluated. RESULTS: In adults aged 18-49 years, OPA GMTs and IgG GMCs were noninferior for all 13 serotypes and statistically significantly higher for all except 1 serotype (OPA GMT) and 5 serotypes (IgG GMCs) compared with adults 60-64 years. Immune responses were highest in the youngest age subgroup (18-29 years). Local reactions and systemic events were more common in adults 18-49 years compared with 60-64 years and were self-limited. CONCLUSION: Immune responses to PCV13 are robust in adults ≥18 years of age, with highest responses observed in the youngest subgroup. Based on its safety and immunologic profile, PCV13 may serve an important therapeutic role in younger adults, particularly those with underlying medical conditions who have an increased risk of serious pneumococcal infections.

Assessment of whole-genome mapping in a well-defined outbreak of Salmonella enterica serotype Saintpaul.

We investigated the use of whole-genome mapping and pulsed-field gel electrophoresis (PFGE) with isolates from an outbreak of Salmonella enterica serotype Saintpaul. PFGE and whole-genome mapping were concordant with 22 of 23 isolates. Whole-genome mapping is a viable alternative tool for the epidemiological analysis of Salmonella food-borne disease investigations.

SigmaB and SarA independently regulate polysaccharide intercellular adhesin production in Staphylococcus epidermidis.

The production of polysaccharide intercellular adhesin (PIA) is an essential process in foreign body infections mediated by Staphylococcus epidermidis. Transcriptional regulation of the icaADBC operon, the genes responsible for production of enzymes that synthesize PIA, is multi-factorial and involves at least SarA and sigmaB. Transcriptional and promoter fusion studies revealed that the decreased transcription of the icaADBC operon observed in a S. epidermidis 1457 sigB mutant is not mediated through a direct interaction of sigmaB-RNA polymerase at the icaADBC promoter region but instead through the upregulation of IcaR, a known repressor of icaADBC transcription. Transcriptional analysis of a 1457 sigB-icaR double mutant confirmed that the decreased icaADBC transcript in 1457 sigB is IcaR dependent. Furthermore, primer extension studies suggest that the icaR promoter appears to be sigmaA dependent, suggesting that sigmaB indirectly controls icaR transcription through an unknown pathway. In addition, it was confirmed that the loss of SarA results in the loss of icaADBC transcription and PIA production in S. epidermidis. It was further demonstrated, through the over-production of SarA in 1457 sigB, that the loss of sarP1 promoter activity in 1457 sigB has little or no effect on the loss of PIA production in this mutant. Finally, it was demonstrated that PIA production could be restored in both 1457 sigB and 1457 sarA by complementing these mutants with a full-length icaADBC operon controlled by a cadmium-inducible noncognate promoter. It is concluded that sigmaB and SarA operate independently of each other to regulate PIA production and biofilm development in S. epidermidis.

Routine childhood immunizations.

The immunizations recommended in the 2001 Childhood Immunization Schedule are safe and effective. Newly approved vaccines, like the pneumococcal conjugate vaccine, hold the promise of eliminating or dramatically reducing persistent causes of childhood morbidity and mortality in the United States.

Managed care enrollee utilization of 911 medical services.

OBJECTIVE: To determine the mechanism by which managed care organization (MCO) enrollees enter the emergency medical services (EMS) system. METHODS: All enrollees belonging to the region's largest MCO and transported to emergency departments by a paramedic-level municipal EMS system were identified from billing records. Dispatch logs were examined to determine the time and origin of the call to the 911 communication center. Patient care records were used to obtain age, the level of care delivered (advanced or basic life support), and whether the patient received any medications while out of hospital. Hospital admission was also determined. RESULTS: Over a six-month period, 195 enrollees were transported. Three modes of 911 EMS system entry were identified: group I-enrollees who called 911 directly; group II-enrollees who called the MCO triage center, who then called 911 on behalf of the patient; and group III--enrollees who were sent to the MCO health center for evaluation, and subsequently the MCO called 911 to transfer the patient to the hospital. Of the 195 patients transported to the emergency department, the dispositions of 108 (55%) patients were obtained. Group I (n = 109) patients were more likely to be transported in the evening (3 PM to 11 PM), less likely to require advanced life support therapies, and less likely to be admitted to the hospital when compared with groups II (n = 32) and III (n = 54) patients. Group III patients were the most likely to receive advanced life support care and require admission to the hospital. CONCLUSION: The majority of MCO enrollees called 911 directly, and were most likely to do so during evening hours. Enrollees who called 911 directly (group I) had a trend toward lower acuity, based on the lowest ALS utilization of any group. Those enrollees who most frequently required advanced life support were those who received initial treatment at the MCO center prior to EMS transport. Though EMS system-specific, this type of descriptive analysis is helpful in assisting both EMS systems and MCOs to better assess utilization of 911 EMS resources by MCO enrollees. This study also challenges the prudent layperson paradigm.

Uncertainty in the amount of power delivered by CO2 medical lasers.

Carbon dioxide medical lasers are being used for various clinical applications with considerable success. Despite the bulk of the generating equipment, the use of light, articulated arms to deliver the power beam to either hand-held or microscope-mounted aiming heads allows accurate power placement. In addition, the beam can be focussed to a small spot size, minimizing damage to adjacent tissue provided that the output power and the precise duration of application are known, and the shielding of deeper tissue has been adequate. In an attempt to assess the reliability of the laser beam as a significant surgical tool (particularly suitable for fine cutting functions in microsurgical procedures), we tested the power output of some of the CO2 surgical lasers now available in Australia. An alarming discrepancy was found between the actual power delivered and the higher power value displayed as being delivered. As these medical lasers were tested and passed as fully functioning by their local agents, it is suggested that purchasers of CO2 lasers should be aware of these possible power inadequacies and subject their equipment to frequent power checks. Otherwise much longer applications of the laser beam will be needed to accomplish the cutting action required, with the consequent infliction of more damage to the surrounding tissues.