Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA.
Vaccine. 2011 Oct 19;29(45):7942-8. doi: 10.1016/j.vaccine.2011.08.071. Epub 2011 Aug 27.
A hepatitis B vaccine was manufactured with a modified process (mpHBV) that incorporated double the usual amount of phosphate. Following a study in young adults, the mpHBV was evaluated in infants in a combination hepatitis B and Haemophilus influenzae B vaccine (mpHBV-Hib).
The mpHBV-Hib was compared with the licensed bivalent HBV-Hib vaccine Comvax™ for immunogenicity and safety. Both vaccines contained 5 μg/0.5 mL of hepatitis B surface antigen (HBsAg) and 7.5 μg/0.5 mL of PRP-OMPC (polyribosylribitol phosphate outer membrane protein complex). A total of 543 infants were randomized 1:1 to receive either vaccine at 2, 4 and 12 months of age. A pneumococcal conjugate vaccine (PCV) was given concomitantly. Immunogenicity was assessed at 1-month post-dose 3.
Seroprotection rates [% subjects with anti-hepatitis B surface antigen antibody titers (anti-HBs) ≥10 mIU/mL)] were 100% and 99% for mpHBV-Hib and the licensed control (Comvax™), respectively. Anti-HBs geometric mean titers (GMTs) were 4204 (95% CI, 3411-5182) and 1683 (95% CI, 1350-2099) mIU/mL, respectively. Anti-PRP seroprotection rates (SPR) at ≥0.15 μg/mL and at ≥1.0 μg/mL were 97% and 94%, respectively, for mpHBV-Hib and 96% and 92%, respectively, for the control. Anti-PRP GMTs were 7.1 μg/mL for mpHBV-Hib and 8.0 μg/mL for the control. Reactogenicity of the two vaccines was similar.
The mpHBV in combination with Hib and with co-administered PCV was highly immunogenic. The safety profile of mpHBV-Hib was comparable to the licensed control. Both the control and mpHBV-Hib met acceptability criteria for seroprotection rates to hepatitis B, with higher anti-HBs GMTs noted for mpHBV-Hib.
一种乙型肝炎疫苗采用改良工艺（mpHBV）制造，其中磷酸盐的含量是通常的两倍。在一项针对年轻人的研究之后，该改良工艺的乙型肝炎疫苗在婴儿中与乙型肝炎和流感嗜血杆菌 B 型联合疫苗（mpHBV-Hib）进行了评估。
将 mpHBV-Hib 与已上市的乙型肝炎和流感嗜血杆菌 B 型联合疫苗 Comvax™ 进行免疫原性和安全性比较。两种疫苗均含有 5μg/0.5mL 的乙型肝炎表面抗原（HBsAg）和 7.5μg/0.5mL 的 PRP-OMPC（多聚核糖醇磷酸外层膜蛋白复合物）。共有 543 名婴儿按 1:1 的比例随机分配至接受两种疫苗中的任意一种，于 2、4 和 12 月龄时接种。同时接种肺炎球菌结合疫苗（PCV）。在第 3 剂后 1 个月评估免疫原性。
血清保护率[（抗乙型肝炎表面抗原抗体滴度≥10mIU/mL 的受试者百分比）]分别为 100%和 99%，mpHBV-Hib 和已上市对照（Comvax™）疫苗均达到 100%。抗-HBs 几何平均滴度（GMT）分别为 4204（95%CI，3411-5182）和 1683（95%CI，1350-2099）mIU/mL。mpHBV-Hib 疫苗血清保护率（SPR）≥0.15μg/mL 和≥1.0μg/mL 分别为 97%和 94%，对照疫苗分别为 96%和 92%。抗-PRP GMT 分别为 7.1μg/mL 和 8.0μg/mL。两种疫苗的不良反应发生率相似。
含有 Hib 和同时接种 PCV 的改良工艺乙型肝炎疫苗具有高度免疫原性。mpHBV-Hib 的安全性与已上市对照疫苗相当。对照疫苗和 mpHBV-Hib 均达到乙型肝炎血清保护率的可接受标准，mpHBV-Hib 的抗-HBs GMT 更高。
