Urbancikova Ingrid, Prymula Roman, Goldblatt David, Roalfe Lucy, Prymulova Karolina, Kosina Pavel
Children's Faculty Hospital Košice, Department of Pediatric Infectious Diseases, Košice, Slovakia.
Charles University, Faculty of Medicine in Hradec Kralove, Department of Social Medicine, Hradec Kralove, Czech Republic.
Vaccine. 2017 Sep 12;35(38):5186-5193. doi: 10.1016/j.vaccine.2017.07.103. Epub 2017 Aug 7.
Although both the 13-valent pneumococcal conjugate vaccine (PCV13) and the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) are widely used, it is unclear how interchangeable they are in terms of immunogenicity.
Two phase 3, open-label, multicenter studies were conducted to assess the immunogenicity and safety of a booster dose of PCV13 in children primed with PHiD-CV or PCV13. In the Czech Republic, 12-15-month-old children received a PCV13 booster after 3-dose priming with either PHiD-CV or PCV13. In Slovakia, 11-12-month-old children received PCV13 following 2-dose priming with either PHiD-CV or PCV13. Serum IgG concentrations were assessed by enzyme-linked immunosorbent assay and functional antibodies were assessed by opsonophagocytic assay (OPA) before the booster and at 1 and 12months afterward. The primary objective of these studies was to assess non-inferiority of OPA titers for serotype 19A in PHiD-CV-primed subjects compared to those in PCV13-primed children 1month post-booster.
A total of 98 subjects in the Czech Republic and 89 subjects in Slovakia were included. One month after the PCV13 booster dose, the IgG and OPA immune responses to serotype 19A in subjects primed with 2 or 3 doses of PHiD-CV were non-inferior to those in subjects primed with PCV13. Non-inferior and persistent immune responses to most other vaccine serotypes were also observed after the PCV13 booster in PHiD-CV-primed subjects. No safety issues were raised in either study.
Overall, robust IgG and OPA immunological responses were observed after booster vaccination with PCV13 in children primed with 2 or 3 doses of PHiD-CV or PCV13, including for serotypes not included in PHiD-CV. These results suggest that these vaccines are interchangeable in terms of safety and immunogenicity and that PCV13 can be used as a booster in the context of mixed schedules. (EudraCT numbers: 2012-005366-35 and 2012-005367-27).
尽管13价肺炎球菌结合疫苗（PCV13）和10价肺炎球菌不可分型流感嗜血杆菌蛋白D结合疫苗（PHiD-CV）都被广泛使用，但它们在免疫原性方面的互换性尚不清楚。
开展了两项3期、开放标签、多中心研究，以评估用PHiD-CV或PCV13进行初始免疫的儿童接种一剂PCV13加强针后的免疫原性和安全性。在捷克共和国，12至15个月大的儿童在接受3剂PHiD-CV或PCV13初始免疫后接种一剂PCV13加强针。在斯洛伐克，11至12个月大的儿童在接受2剂PHiD-CV或PCV13初始免疫后接种PCV13。在加强免疫前以及加强免疫后1个月和12个月，通过酶联免疫吸附测定评估血清IgG浓度，并通过调理吞噬试验（OPA）评估功能性抗体。这些研究的主要目的是评估在加强免疫后1个月，与接种PCV13初始免疫的儿童相比，接种PHiD-CV初始免疫的受试者中19A血清型的OPA滴度是否非劣效。
捷克共和国共纳入98名受试者，斯洛伐克共纳入89名受试者。在接种PCV13加强针1个月后，接种2剂或3剂PHiD-CV初始免疫的受试者对19A血清型的IgG和OPA免疫反应不劣于接种PCV13初始免疫的受试者。在接种PHiD-CV初始免疫的受试者中，接种PCV13加强针后对大多数其他疫苗血清型也观察到非劣效且持续的免疫反应。两项研究均未出现安全问题。
总体而言，在接种2剂或3剂PHiD-CV或PCV13进行初始免疫的儿童中，接种PCV13加强针后观察到了强烈的IgG和OPA免疫反应，包括对PHiD-CV中未包含的血清型。这些结果表明，这些疫苗在安全性和免疫原性方面具有互换性，并且PCV13可用于混合免疫程序中的加强免疫。（欧盟临床试验注册号：2012-005366-35和2012-005367-27）
