Pichichero Michael E, Blatter Mark M, Reisinger Keith S, Harrison Christopher J, Johnson Candice E, Steinhoff Mark C, Senders Shelly D, Rothstein Edward P, Willems Paul, Howe Barbara J
University of Rochester Medical Center, Rochester, NY 14642, USA.
Pediatr Infect Dis J. 2002 Sep;21(9):854-9. doi: 10.1097/00006454-200209000-00014.
To assess the impact of a birth dose of hepatitis B vaccine (HepB) on the reactogenicity and immunogenicity of a novel diphtheria-tetanus-acellular pertussis (DTaP)- HepB-inactivated poliovirus (IPV)/ type b (Hib) combination vaccine administered subsequently at 2, 4 and 6 months of age.
Neonates ( = 550) were randomized into two groups with regard to receipt of HepB at birth. All subjects in both groups received DTaP-HepB-IPV/Hib at 2, 4 and 6 months of age. Solicited local and general adverse events were recorded for 8 days after each dose. Antibodies to hepatitis B surface antigen were measured 1 month after the third dose of DTaP-HepB-IPV/Hib in a subset of 170 infants; titers of at least 10 mIU/ml were considered protective.
The DTaP-HepB-IPV/Hib combination vaccine was well-tolerated in both groups. Of the infants who received a birth dose of HepB, 22.6% had severe (Grade 3) reactions after any of the three doses of DTaP-HepB-IPV/Hib combination vaccine compared with 23.2% of subjects who did not receive a birth dose of HepB (difference, -0.5%; 90% confidence interval, -7.4 to 6.1). Antibody to hepatitis B surface antigen titers were > or =10 mIU/ml for all tested infants. Geometric mean titers were 2996.2 and 1240.1 mIU/ml with and without a birth dose of HepB, respectively.
A HepB birth dose does not increase the reactogenicity of a combination DTaP-HepB-IPV/Hib vaccine administered at 2, 4 and 6 months of age, and all tested subjects achieved protective anti-HBs titers (> or =10 mIU/ml), although geometric mean titers were higher when a birth dose of HepB was given.
评估出生时接种一剂乙肝疫苗（HepB）对随后在2、4和6月龄接种的新型白喉-破伤风-无细胞百日咳（DTaP）-乙肝-灭活脊髓灰质炎病毒（IPV）/b型流感嗜血杆菌（Hib）联合疫苗的反应原性和免疫原性的影响。
根据出生时是否接种HepB，将550名新生儿随机分为两组。两组所有受试者均在2、4和6月龄接种DTaP-HepB-IPV/Hib。每次接种后记录8天内的局部和全身主动报告的不良事件。在170名婴儿亚组中，在第三剂DTaP-HepB-IPV/Hib接种后1个月测量乙肝表面抗原抗体。抗体滴度至少为10 mIU/ml被视为具有保护性。
两组对DTaP-HepB-IPV/Hib联合疫苗的耐受性均良好。在出生时接种HepB的婴儿中，22.6%在三剂DTaP-HepB-IPV/Hib联合疫苗中的任何一剂接种后出现严重（3级）反应，而未接种出生剂量HepB的受试者为23.2%（差异为-0.5%；90%置信区间为-7.4至6.1）。所有检测婴儿的乙肝表面抗原抗体滴度均≥10 mIU/ml。接种和未接种出生剂量HepB的婴儿的几何平均滴度分别为2996.2和1240.1 mIU/ml。
出生时接种HepB不会增加2、4和6月龄接种的DTaP-HepB-IPV/Hib联合疫苗的反应原性，并且所有检测受试者均达到保护性抗-HBs滴度（≥10 mIU/ml），尽管接种出生剂量HepB时几何平均滴度更高。
