Department of Pediatrics and Center for Vaccine Evaluation and Study, Medical Research Institute, Ewha Womans University School of Medicine, Seoul, Republic of Korea.
Vaccine. 2012 Feb 27;30(10):1886-94. doi: 10.1016/j.vaccine.2011.12.122. Epub 2012 Jan 13.
The World Health Organization (WHO) recommends that all countries adopt Haemophilus influenzae type b (Hib) vaccine into routine child immunization programs to protect children from the significant burden of life-threatening pneumonia and meningitis.
In this blind, comparative, randomized, phase-III Korean multicenter study, we assessed immunogenicity and safety following primary vaccination of a new H. influenzae type b tetanus toxoid conjugate vaccine, LBVH0101 (LG Life Sciences, Ltd., Seoul, Korea) compared with Hiberix™ (GSK, Rixensart, Belgium) in Korean children at 2, 4 and 6 months of age followed by a booster vaccination at 12-15 months. Serum anti-PRP IgG concentration and bactericidal activity were determined. Local/systemic symptoms were assessed after vaccination. Serious adverse events were recorded throughout the study.
A total of 185 infants were included in immunogenicity evaluations. After the second and third doses of LBVH0101, 90.32% and 100% of infants achieved an antibody level ≥1 μg/mL, respectively, compared with 78.26% and 96.74% of those who received Hiberix™. After the second vaccination, the geometric mean concentration (GMC) of LBVH0101 recipients was 7.34 μg/mL and was higher than that of Hiberix™ recipients (3.55 μg/mL). After the third vaccination, the GMCs were 14.59 μg/mL and 12.15 μg/mL in the LBVH0101 and Hiberix™ recipients, respectively. The booster dose produced higher antibody concentrations: 30.25 μg/mL and 71.64 μg/mL for LBVH0101 and Hiberix™ recipients, respectively. Bactericidal capacity and antibody potency of anti-PRP IgG induced by LBVH0101 was 35.05 and 116.27 after the second and third vaccinations, respectively, compared with 53.76 and 79.64 for Hiberix™. Anti-PRP IgG seroprotection rate and GMC were similar post-primary immunization between the groups; both showed functional maturation and similar booster responses. LBVH0101 had comparable safety results as the control vaccine, Hiberix™, as most of the solicited adverse events and unsolicited adverse events upon LBVH0101 administration were mild in severity. No serious vaccination-related adverse reactions were observed.
LBVH0101 showed a good immunogenicity and safety profile in infants and children. The two-dose infant-priming schedule with a booster dose may suffice for Hib immunization in Korean infants (Clinical trial registration numbers: NCT01019772 and NCT01251133).
世界卫生组织（WHO）建议所有国家将乙型流感嗜血杆菌（Hib）疫苗纳入儿童常规免疫规划，以保护儿童免受危及生命的肺炎和脑膜炎的严重负担。
在这项盲法、对照、随机、III 期韩国多中心研究中，我们评估了新型 Hib 破伤风类毒素结合疫苗 LBVH0101（LG Life Sciences，Ltd.，首尔，韩国）与 Hiberix™（GSK，Rixensart，比利时）在 2、4 和 6 个月龄时进行初级免疫接种后，12-15 个月时进行加强免疫接种后的免疫原性和安全性。测定血清抗 PRP IgG 浓度和杀菌活性。接种后评估局部/全身症状。记录整个研究期间的严重不良事件。
共有 185 名婴儿纳入免疫原性评估。与接受 Hiberix™的婴儿相比，在接受 LBVH0101 的第二和第三剂后，分别有 90.32%和 100%的婴儿达到抗体水平≥1μg/mL，分别为 78.26%和 96.74%。在第二次接种后，LBVH0101 受种者的几何平均浓度（GMC）为 7.34μg/mL，高于 Hiberix™受种者（3.55μg/mL）。在第三次接种后，LBVH0101 和 Hiberix™受种者的 GMC 分别为 14.59μg/mL和 12.15μg/mL。加强剂量产生更高的抗体浓度：LBVH0101 和 Hiberix™受种者分别为 30.25μg/mL 和 71.64μg/mL。LBVH0101 诱导的抗 PRP IgG 的杀菌能力和抗体效价分别为第二次和第三次接种后的 35.05 和 116.27，而 Hiberix™为 53.76 和 79.64。两组原发性免疫接种后抗 PRP IgG 血清保护率和 GMC 相似；两者均表现出功能成熟和相似的加强反应。LBVH0101 的安全性与对照疫苗 Hiberix™相当，因为 LBVH0101 给药后大多数不良事件和非预期不良事件均为轻度。未观察到与疫苗接种相关的严重不良反应。
LBVH0101 在婴儿和儿童中表现出良好的免疫原性和安全性。在韩国婴儿中，两剂婴儿初免加一剂加强免疫的方案可能足以预防 Hib（临床试验注册号：NCT01019772 和 NCT01251133）。
