Tejedor Juan C, Moro Manuel, Ruiz-Contreras Jesús, Castro Javier, Gómez-Campderá José Antonio, Navarro María Luisa, Merino José Manuel, Martín-Ancel Ana, Roca Joan, García-Del-Rí Manuel, Jurado Antonio, Díez-Delgado Francisco Javier, Omeñaca Félix, García-Sicilia José, Boceta Reyes, García-Corbeira Pilar, Collard Alix, Boutriau Dominique, Schuerman Lode, Jacquet Jeanne-Marie
Móstoles Hospital, Madrid, Spain.
Pediatr Infect Dis J. 2007 Jan;26(1):1-7. doi: 10.1097/01.inf.0000247070.60063.09.
This phase II study evaluated the immunogenicity and reactogenicity of primary vaccination with a novel Hib-MenC conjugate vaccine (GlaxoSmithKline [GSK] Biologicals) coadministered with DTPa-HBV-IPV (GSK Biologicals) at 2, 4 and 6 months.
Healthy infants were randomized to receive Hib-MenC coadministered with DTPa-HBV-IPV (N = 117) or MenC-CRM (Wyeth) coadministered with DTPa-HBV-IPV/Hib (GSK Biologicals; N = 120) at 2, 4 and 6 months. Antibody concentrations were measured before vaccination and after doses 2 and 3. Solicited local and general symptoms, unsolicited symptoms and serious adverse events (SAEs) were recorded.
All subjects in the Hib-MenC group had seroprotective titers of anti-PRP antibodies (>or=0.15 microg/mL) and SBA-MenC titers (>or=1:8) 1 month after the third dose. These responses were noninferior to those seen in the control group, in which a 99.1% seroprotection rate was observed for both Hib and MenC. At that time, anti-PRP and SBA-MenC GMTs were significantly higher in the Hib-MenC group (12.8 microg/mL and 2467.1 microg/mL, respectively) than in the control group (3.8 microg/mL and 1833.7 microg/mL). High seroprotection rates were already observed after the second dose of Hib-MenC; 96.4% and 100% of subjects were seroprotected to Hib and MenC, respectively. Immune responses to coadministered antigens were unimpaired; seroprotection/vaccine response rates >or=96.5% were recorded postdose 3 in the Hib-MenC group. No differences in reactogenicity were seen between the 2 study groups.
Coadministration of a Hib-MenC conjugate vaccine with DTPa-HBV-IPV is well tolerated and immunogenic, and does not impair the immune response to any of the coadministered antigens.
本II期研究评估了一种新型b型流感嗜血杆菌-脑膜炎球菌结合疫苗（葛兰素史克生物制品公司）与白喉破伤风无细胞百日咳-乙肝-脊髓灰质炎灭活疫苗（葛兰素史克生物制品公司）在2、4和6月龄时联合进行初次疫苗接种的免疫原性和反应原性。
将健康婴儿随机分为两组，一组在2、4和6月龄时接受b型流感嗜血杆菌-脑膜炎球菌结合疫苗与白喉破伤风无细胞百日咳-乙肝-脊髓灰质炎灭活疫苗联合接种（N = 117），另一组在相同月龄接受脑膜炎球菌结合疫苗（惠氏公司）与白喉破伤风无细胞百日咳-乙肝-脊髓灰质炎灭活疫苗/b型流感嗜血杆菌结合疫苗（葛兰素史克生物制品公司；N = 120）联合接种。在接种疫苗前以及第2剂和第3剂接种后测量抗体浓度。记录主动报告的局部和全身症状、非主动报告的症状以及严重不良事件（SAE）。
b型流感嗜血杆菌-脑膜炎球菌结合疫苗组的所有受试者在第3剂接种后1个月时抗PRP抗体（≥0.15μg/mL）和SBA-脑膜炎球菌抗体（≥1:8）的滴度均具有血清保护作用。这些反应不劣于对照组，对照组中b型流感嗜血杆菌和脑膜炎球菌的血清保护率均为99.1%。此时，b型流感嗜血杆菌-脑膜炎球菌结合疫苗组的抗PRP和SBA-脑膜炎球菌几何平均滴度（GMT）（分别为12.8μg/mL和2467.1μg/mL）显著高于对照组（3.8μg/mL和1833.7μg/mL）。在接种b型流感嗜血杆菌-脑膜炎球菌结合疫苗第2剂后即已观察到高血清保护率；分别有96.4%和100%的受试者对b型流感嗜血杆菌和脑膜炎球菌具有血清保护作用。对联合接种抗原的免疫反应未受损害；b型流感嗜血杆菌-脑膜炎球菌结合疫苗组在第3剂接种后血清保护/疫苗反应率≥96.5%。两个研究组之间在反应原性方面未见差异。
b型流感嗜血杆菌-脑膜炎球菌结合疫苗与白喉破伤风无细胞百日咳-乙肝-脊髓灰质炎灭活疫苗联合接种耐受性良好且具有免疫原性，并且不会损害对任何联合接种抗原的免疫反应。
