Villarreal Pérez Jesús Zacarías, Ramírez Aranda José Manuel, de la O Cavazos Manuel, Zamudio Osuna Michelle de J, Perales Dávila José, Ballesteros Elizondo María Romelia, Gómez Meza Marco Vinicio, García Elizondo Francisco Javier, Rodríguez González Azucena M
a Universidad Autónoma de Nuevo León , Monterrey , Mexico.
b Servicios de Salud de Nuevo León , Monterrey , Mexico.
Hum Vaccin Immunother. 2017 Jan 2;13(1):128-135. doi: 10.1080/21645515.2016.1232786.
Immunization with the tetanus, diphtheria, and pertussis (Tdap) vaccine raises controversies on immunogenicity and possible antibody interference. We performed an experimental, double-blind, parallel group controlled clinical trial to evaluate the safety and immunogenicity of the Tdap vaccine in 204 pregnant women and their children and to determine its interference in antibody production. Pregnant women 18 to 38 y of age with 12 to 24 weeks gestation, a low obstetric risk, and without serious disease were randomly selected. The experimental group received 0.5 mL IM of Tdap and the control group normal saline. Six blood samples were drawn before and after solution application, and from the umbilical cord of the infants and at 2, 4, and 6 months of age. Pertactin and Pertussis toxin antibodies and possible interference of maternal antibodies with the vaccine were determined. In the experimental group, antibodies against Bordetella pertussis pertactin (anti-PRN) (112 E/mL 95% CI 89.9-139.9) and antibodies against pertussis toxin (anti-PT) (24.0 E/mL, 95% CI 18.3-31.4) were elevated in the mother before vaccination. These were higher in the umbilical cord and descended in the infant at 2 months (71.4 (95% CI 56.8-89.7 and 10.9; 95% CI 8.7-13.7, respectively). Anti-PT showed a delay in production. Tdap safety was confirmed with only mild local pain at 24 and 48 hours. Anti-PRN and anti-PT antibodies in the infant descend at 2 months of age. There is a delay in anti-PT in children of immunized mothers. Further studies are needed to elucidate its clinical significance.
破伤风、白喉和百日咳（Tdap）疫苗的免疫接种引发了关于免疫原性和可能的抗体干扰的争议。我们进行了一项实验性、双盲、平行组对照临床试验，以评估Tdap疫苗在204名孕妇及其子女中的安全性和免疫原性，并确定其对抗体产生的干扰。随机选择年龄在18至38岁、妊娠12至24周、产科风险低且无严重疾病的孕妇。实验组接受0.5 mL肌内注射Tdap，对照组接受生理盐水。在给药前后、婴儿脐带以及2、4和6月龄时采集六份血样。测定百日咳杆菌黏附素和百日咳毒素抗体以及母体抗体对疫苗的可能干扰。在实验组中，接种疫苗前母亲体内抗百日咳杆菌黏附素（抗-PRN）抗体（112 E/mL，95%置信区间89.9-139.9）和抗百日咳毒素（抗-PT）抗体（24.0 E/mL，95%置信区间18.3-31.4）升高。这些抗体在脐带血中更高，在婴儿2个月时下降（分别为71.4（95%置信区间56.8-89.7）和10.9；95%置信区间8.7-13.7）。抗-PT抗体产生延迟。仅在24和48小时出现轻微局部疼痛，证实了Tdap的安全性。婴儿体内的抗-PRN和抗-PT抗体在2个月龄时下降。免疫母亲的孩子中抗-PT抗体产生延迟。需要进一步研究以阐明其临床意义。
