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印度的六价疫苗:现状。

Hexavalent Vaccines in India: Current Status.

机构信息

Department of Pediatrics, Max Superspeciality Hospital, Delhi, India.

Glaxo Smith Kline Biologicals SA, Mumbai, India. Correspondence to: Dr Raunak Parikh, GSK, Dr. Annie Besant Road, Mumbai 400 030, Maharashtra, India.

出版信息

Indian Pediatr. 2019 Nov 15;56(11):939-950.

PMID:31729324
Abstract

Hexavalent vaccines containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, poliomyelitis, and hepatitis B virus antigens have the potential to be used for the primary series in India (6, 10, 14 weeks of age) and the toddler booster dose. Three hexavalent vaccines are available in India: DTwP-Hib/HepB-IPV (wP-hexa), DTaP-IPV-HB-PRP~T(2aP-hexa), and DTaP-HBV-IPV/Hib (3aP-hexa). In the three published phase-3 Indian studies, pertussis 'vaccine response' rates 1 month after a 6-10-14-week primary series were 68.4-75.7% for wP-hexa, 93.8-99.3% for 2aP-hexa, and 97.0-100% for 3aP-hexa; seroprotection rates for the other five antigens were 88.2-100%, 49.6-100%, and 98.6-100%, respectively. Studies outside India show: good immunogenicity/safety after boosting dosing; immune persistence to age 4.5 years (2aP-hexa), 7-9 years (3aP-hexa) (all antigens), and 9-10 and 14-15 years, respectively (hepatitis B); and successful co-administration with other vaccines. Hexavalent vaccines could reduce the number of injections, simplify vaccination schedules, and improve compliance.

摘要

六价疫苗含有白喉、破伤风、百日咳、流感嗜血杆菌 b 型、脊髓灰质炎和乙型肝炎病毒抗原,有可能在印度用于基础系列(6、10、14 周龄)和幼儿加强剂量。印度有三种六价疫苗:DTwP-Hib/HepB-IPV(wP-hexa)、DTaP-IPV-HB-PRP~T(2aP-hexa)和 DTaP-HBV-IPV/Hib(3aP-hexa)。在三项已发表的印度 3 期研究中,6-10-14 周基础系列接种后 1 个月,wP-hexa 的百日咳“疫苗反应”率为 68.4-75.7%,2aP-hexa 为 93.8-99.3%,3aP-hexa 为 97.0-100%;其他五种抗原的血清保护率分别为 88.2-100%、49.6-100%和 98.6-100%。印度以外的研究表明:加强剂量后具有良好的免疫原性/安全性;免疫持久性至 4.5 岁(2aP-hexa)、7-9 岁(3aP-hexa)(所有抗原)和 9-10 岁和 14-15 岁(乙型肝炎);与其他疫苗联合使用成功。六价疫苗可减少注射次数、简化疫苗接种计划并提高依从性。

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