2014年3月12日讯 /生物谷BIOON/ --辉瑞（Pfizer）3月12日公布了肺炎球菌结合型疫苗Prevenar 13（沛儿13）里程碑意义的大型CAPiTA研究的详细数据。该项研究涉及约8.5万名受试者，研究结果表明，Prevenar 13预防了65岁及以上成人群体中疫苗型社区获得性肺炎（community-acquired pneumonia，CAP）的首次流行发作（first episode），达到了研究的主要目标。这是首次在成人群体中明确地证明疫苗型肺炎球菌CAP流行发作显著降低的研究，更重要的是，显著降低了非菌血症性/非侵入性疫苗型肺炎球菌CAP的流行发作。该项研究的数据，已提交至2014年3月12日在印度海德拉巴举行的第九届肺炎球菌及肺炎球菌病国际研讨会（ISPPD-9）。

CAPiTA（Community-Acquired Pneumonia Immunization Trial in Adults，成人社区获得性肺炎免疫试验）研究也达到了2个次要终点：（i）显著降低了非菌血症性/非侵入性疫苗型肺炎球菌CAP；（ii）显著降低了疫苗型侵入性肺炎球菌病（IPD）。

研究中，与安慰剂组相比，Prevenar 13免疫组疫苗型CAP首次发作减少45.56%（p=0.0006）。同时，Prevenar 13免疫组非菌血症性/非侵入性疫苗型肺炎球菌CAP首次发作减少45.00%（p=0.0067），疫苗型IPD首次发作减少75.00%。该项研究中Prevenar 13的安全性与既往研究一致。

其他数据显示，接种Prevenar 13的受试者，在免疫之后长达4年的时间内，疫苗型CAP、非菌血症性/非侵入性疫苗型CAP、疫苗型IPD首次发作均得到降低。

CAPiTA研究的数据，将作为Prevenar 13用于成人的建议的重要组成部分。其他关键因素，也将加以考虑，包括成年群体中当前的肺炎球菌病负担。

关于沛儿13（Prevenar 13）：

Prevenar 13是由辉瑞开发的一款13价肺炎链球菌结合型疫苗，是目前唯一一种获FDA和欧盟批准用于全年龄段（从婴儿期至成年期）的肺炎球菌疫苗，用于预防13株肺炎链球菌菌株（1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,23F）导致的肺炎球菌性肺炎和侵入性疾病。Prevenar 13于2011年由FDA通过加速审批程序批准，以解决老年群体中的医疗需求。作为加速审批的要求，辉瑞开展了CAPiTA来验证Prevenar13的临床利益。（生物谷Bioon.com）

英文原文：Pfizer (PFE) Reports Prevenar 13 Met Primary, Secondary Objectives in CAPTA

Pfizer Inc. (NYSE: PFE) presented detailed results of the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the landmark study of approximately 85,000 subjects, demonstrating that Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) prevented a first episode of vaccine-type community-acquired pneumonia (CAP) in adults 65 years of age and older, the study’s primary objective. This trial is the first in adults to clearly demonstrate a significant reduction in vaccine-type pneumococcal CAP, and importantly, non-bacteremic/non-invasive vaccine-type pneumococcal CAP. Results were presented during the late-breaker session at the 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Hyderabad, India, on March 12, 2014.

CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) also met both of its secondary study objectives –significant reduction in (i) non-bacteremic/non-invasive vaccine-type pneumococcal CAP and (ii) vaccine-type invasive pneumococcal disease (IPD).

Regarding the study’s primary objective, there were 45.56 percent fewer first episodes of vaccine-type CAP among Prevenar 13-vaccinated subjects than in subjects who received placebo (P=0.0006). Regarding the study’s secondary objectives, the Prevenar 13 group experienced 45.00 percent fewer first episodes of non-bacteremic/non-invasive vaccine-type CAP (P=0.0067) and 75.00 percent fewer first episodes of vaccine-type IPD (P=0.0005) compared with the placebo group. The safety profile of Prevenar 13 in this study was consistent with studies previously conducted in adults.

Additional data showed reductions in vaccine-type CAP, non-bacteremic/non-invasive vaccine-type CAP, and vaccine-type IPD for up to four years after vaccination among subjects who received Prevenar 13.

“With the aging of the population, hospitalizations due to pneumococcal pneumonia represent a growing burden to public health systems. Evidence from this study is particularly important for a population in which age-related decline of the immune system makes it difficult to prevent disease,” said Dr. Emilio A. Emini, senior vice president, Vaccine Research and Development, Pfizer.

“This study demonstrated that vaccination with Prevenar 13 can prevent a significant portion of pneumococcal community-acquired pneumonia in adults aged 65 and older, which is an important global public health goal,” said principal investigator Prof. Marc Bonten, professor of Molecular Epidemiology of Infectious Diseases, Department of Medical Microbiology, Julius Center for Health Sciences & Primary Care, University Medical Center Utrecht in the Netherlands.

The CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) study data will be an important part of any consideration of potential new or updated recommendations for Prevenar 13 in adults. Other key factors also are expected to be taken into consideration, including the current burden of pneumococcal disease in adults.

About CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults)

In 2011, Prevnar 13 was licensed by the U.S. Food and Drug Administration under an accelerated approval process to address an unmet medical need in older adults. As a requirement of the accelerated approval pathway, Pfizer conducted CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) to verify clinical benefit.

This was a parallel-group, randomized, placebo-controlled, double-blind, single-center trial in which subjects aged 65 years and older were randomly assigned to receive a single dose of either Prevnar 13 or placebo. A total of 84,496 subjects were enrolled. The trial was conducted by Julius Clinical, a spin-off of the Julius Center for Health Sciences and Primary Care, a division of the University Medical Center Utrecht in the Netherlands. Fifty-eight sentinel hospitals were used for the surveillance of CAP and IPD.

Vaccine-type CAP (VT-CAP) was defined as CAP caused by any Streptococcus pneumoniae serotype included in the vaccine. Non-bacteremic/noninvasive VT-CAP was defined as CAP in which vaccine-type S. pneumoniae caused the pneumonia, but was not detected concurrently in the bloodstream or any other normally sterile site. Vaccine-type IPD was defined as a case in which vaccine-type S. pneumoniae was present in the bloodstream or any other normally sterile site, with or without pneumonia.

关键词：辉瑞,沛儿13,Prevenar 13,肺炎球菌,疫苗

信息来源:生物谷