Zorman Julie K, Esser Mark, Raedler Michael, Kreiswirth Barry N, Ala'Aldeen Dlawer A A, Kartsonis Nicholas, Smugar Steven S, Anderson Annaliesa S, McNeely Tessie, Arduino Jean Marie
Merck Sharp & Dohme Corp.; Whitehouse Station, NJ USA.
Hum Vaccin Immunother. 2013 Sep;9(9):1857-64. doi: 10.4161/hv.25253. Epub 2013 Jun 18.
Staphylococcus aureus is a well-recognized, clinically important cause of nosocomial infections, and as such, a vaccine to prevent S. aureus infections would be an important achievement. A Phase IIB/III study of V710, a vaccine containing iron-regulated surface determinant B (IsdB), demonstrated significant sero-conversion rates in cardiovascular surgery patients following a single pre-surgery immunization. However, the vaccine was not efficacious in preventing bacteremia or deep sternal wound infection post-surgery, thus raising the possibility that IsdB might not be available for immune recognition during infection. The purpose of the work described herein was to evaluate and quantify the naturally occurring anti-IsdB levels at baseline and over time during infection, to understand whether IsdB is expressed during a S. aureus infection in hospitalized non-vaccinated patients. We evaluated baseline and follow-up titers in 3 populations: (1) healthy subjects, (2) hospitalized patients with non-S. aureus infections, and (3) hospitalized patients with S. aureus infections. Baseline anti-IsdB levels generally overlapped between the 3 groups, but were highly variable within each group. In healthy subjects, baseline and follow-up levels were highly correlated (Spearman's rho = 0.93), and the geometric mean fold-rise (GMFR) in anti-IsdB levels between study entry and last value was 0.9-fold (95% confidence interval (CI): 0.8 to 1.0 ; p = 0.09), showing no trend over time. The convalescent GMFR in anti-IsdB levels from baseline was 1.7-fold (95% CI: 1.3 to 2.2, p = 0.0008) during S. aureus infection, significantly different from the 1.0-fold GMFR (95% CI: 0.9-1.2, p = 0.60) in non-S. aureus infection, p = 0.005. Additionally, S. aureus isolates (51) obtained from the hospitalized patient group expressed the IsdB protein in vitro. Collectively, these data suggest that IsdB expression levels rise substantially following infection with S. aureus, but not with other pathogens, and IsdB is likely well-conserved across S. aureus strains.
金黄色葡萄球菌是一种公认的、临床上引起医院感染的重要病原体,因此,一种预防金黄色葡萄球菌感染的疫苗将是一项重要成果。一项关于V710(一种含有铁调节表面决定簇B(IsdB)的疫苗)的IIB/III期研究表明,在心血管外科手术患者术前单次免疫后,血清转化率显著。然而,该疫苗在预防术后菌血症或深部胸骨伤口感染方面无效,因此增加了IsdB在感染期间可能无法被免疫识别的可能性。本文所述工作的目的是评估和量化感染期间基线及随时间推移自然产生的抗IsdB水平,以了解在未接种疫苗的住院患者发生金黄色葡萄球菌感染时IsdB是否表达。我们评估了3组人群的基线和随访滴度:(1)健康受试者,(2)患有非金黄色葡萄球菌感染的住院患者,以及(3)患有金黄色葡萄球菌感染的住院患者。3组之间的基线抗IsdB水平通常重叠,但每组内差异很大。在健康受试者中,基线和随访水平高度相关(斯皮尔曼等级相关系数rho = 0.93),研究开始时与最后一次测量时抗IsdB水平的几何平均倍数升高(GMFR)为0.9倍(95%置信区间(CI):0.8至1.0;p = 0.09),未显示随时间的趋势。在金黄色葡萄球菌感染期间,抗IsdB水平从基线开始的恢复期GMFR为1.7倍(95%CI:1.3至2.2,p = 0.0008),与非金黄色葡萄球菌感染时1.0倍的GMFR(95%CI:0.9 - 1.2,p = 0.60)显著不同,p = 0.005。此外,从住院患者组获得的51株金黄色葡萄球菌分离株在体外表达IsdB蛋白。总体而言,这些数据表明,感染金黄色葡萄球菌后IsdB表达水平大幅上升,但感染其他病原体后则不然,并且IsdB在金黄色葡萄球菌菌株中可能高度保守。