随机研究两种 Tdap 疫苗在已接种 DTaP 的青少年中的免疫应答，并与已接种 DTwP 的青少年的结果进行比较。

Randomized study of immune responses to two Tdap vaccines among adolescents primed with DTaP and comparison with results among adolescents primed with DTwP.

机构信息

US Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA; Department of Health Policy, Vanderbilt University School of Medicine, Nashville, TN, USA.

US Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA; Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

出版信息

Vaccine. 2019 Aug 14;37(35):5003-5008. doi: 10.1016/j.vaccine.2019.07.015. Epub 2019 Jul 10.

DOI:10.1016/j.vaccine.2019.07.015

PMID:31301919

Abstract

BACKGROUND

It has been reported that persons primed with acellular (DTaP) pertussis vaccines have reduced duration of pertussis protection compared with those primed with whole-cell (DTwP) vaccines. However, due to the rapid transition to acellular vaccines, studies attempting directly to compare protection among DTaP-primed vs DTwP-primed individuals are subject to confounding by age and other limitations of ecological studies. Using validated assay results and stored sera from multiple Tdap studies, we evaluated two licensed Tdap vaccines among DTaP-primed adolescents to allow comparison with results obtained in the same laboratory from earlier studies involving DTwP-primed adolescents.

METHODS

Participants 11-12 years of age who had received exactly 5 doses of DTaP vaccine prior to 7 years of age were randomly assigned in 2012 to receive one of two licensed Tdap vaccines. Serum specimens obtained pre- and post-vaccination were assayed for responses to the vaccines. Current results were then compared to results obtained in the same laboratory from prior randomized Tdap studies conducted among adolescents primed with DTwP or DTaP.

RESULTS

Both Tdap vaccines produced strong antibody responses to diphtheria and tetanus; responses to contained pertussis antigens were consistent with the differing levels of those antigens in each Tdap vaccine. However, postvaccination pertussis antibody responses were as much as 71% lower in these DTaP-primed adolescents compared with responses among DTwP-primed adolescents in a prior study of the same two Tdap vaccines. In contrast, results from the present study were similar to those seen in another study of Tdap among DTaP-primed adolescents.

DISCUSSION

Taken together, these results from randomized clinical trials provide direct evidence of reduced antibody responses to both licensed Tdap vaccines among adolescents primed with DTaP vaccine, compared with adolescents primed with DTwP vaccine. Clinical trial registry number: ClinicalTrials.gov, NCT01629589.

摘要

背景

据报道，与接种全细胞（DTwP）疫苗相比，接种无细胞（DTaP）百日咳疫苗的个体百日咳保护持续时间缩短。然而，由于迅速转向使用无细胞疫苗，因此尝试直接比较 DTaP 疫苗接种与 DTwP 疫苗接种个体之间保护的研究受到年龄和其他生态研究局限性的混杂因素的影响。本研究使用来自多个 Tdap 研究的经过验证的检测结果和储存血清，评估了两种已批准的 Tdap 疫苗在 DTaP 疫苗接种的青少年中的作用，以与同一实验室从之前涉及 DTwP 疫苗接种的青少年的研究中获得的结果进行比较。

方法

2012 年，年龄在 11-12 岁之间且在 7 岁前已接受 5 剂 DTaP 疫苗接种的参与者被随机分配接受两种已批准的 Tdap 疫苗中的一种。接种疫苗前后采集的血清标本用于检测对疫苗的反应。当前的结果与同一实验室之前进行的针对 DTwP 或 DTaP 疫苗接种的青少年的随机 Tdap 研究获得的结果进行了比较。

结果

两种 Tdap 疫苗均对白喉和破伤风产生强烈的抗体反应；疫苗中包含的百日咳抗原的反应与每种 Tdap 疫苗中抗原的不同水平一致。然而，与之前相同两种 Tdap 疫苗的研究中 DTwP 疫苗接种的青少年相比，这些 DTaP 疫苗接种的青少年的接种后百日咳抗体反应低了 71%。相比之下，本研究的结果与另一项针对 DTaP 疫苗接种的青少年的 Tdap 研究的结果相似。