Tregnaghi Miguel, López Pio, Rocha Crisanta, Rivera Luis, David Marie-Pierre, Rüttimann Ricardo, Schuerman Lode
Centro de Desarrollo de Proyectos Avanzados, Córdoba, Argentina.
Rev Panam Salud Publica. 2006 Mar;19(3):179-88. doi: 10.1590/s1020-49892006000300006.
In 1998 the World Health Organization (WHO) recommended the inclusion of Haemophilus influenza type B (Hib) conjugate vaccines in infant immunization programs, whenever in accordance with national priorities. GlaxoSmithKline Biologicals has developed a new pentavalent combined diphtheria-tetanus-whole cell pertussis-hepatitis B/Hib (DTPw-HB/Hib) vaccine containing 5 microg of polyribosylribitol phosphate (PRP), and we assessed the immunogenicity and reactogenicity of primary and booster vaccination of healthy children with this new vaccine compared with a reference regimen consisting of the licensed DTPw-HB (Tritanrix) and Hib (Hiberix) vaccines given as simultaneous concomitant injections.
We performed a randomized, double-blind study from September 1998 to August 1999 to establish the immunogenicity and reactogenicity of primary and booster vaccination of healthy children with the new pentavalent combined DTPw-HB/Hib vaccine given as a single injection, compared with the reference regimen.
Both vaccination regimens elicited excellent immune responses, with all subjects in both groups achieving seroprotective anti-PRP antibody concentrations of > or = 0.15 microg/mL one month after primary vaccination. The combined DTPw-HB/Hib vaccine was non-inferior to the licensed vaccines in terms of seroprotection/seropositivity/vaccine response rates for all antigen components. Persistence of antibodies against all study vaccine antigens up to the time of booster vaccination was comparable between groups, and a marked increase of all antibody concentrations was observed after the booster dose. Both vaccine regimens were similar in terms of their overall reactogenicity profiles.
Our results indicate that the new DTPw-HB/Hib pentavalent combination vaccine provides an efficient and reliable way of implementing WHO recommendations for controlling hepatitis B and Hib infections on a worldwide basis.
1998年，世界卫生组织（WHO）建议根据各国实际情况，将B型流感嗜血杆菌（Hib）结合疫苗纳入婴儿免疫规划。葛兰素史克生物制品公司研发了一种新的五价联合疫苗，即白喉-破伤风-全细胞百日咳-乙肝/Hib（DTPw-HB/Hib）疫苗，每剂含5微克多聚核糖基核糖醇磷酸酯（PRP）。我们评估了健康儿童接种该新疫苗进行初次和加强免疫接种的免疫原性和反应原性，并与由已获许可的DTPw-HB（Tritanrix）和Hib（Hiberix）疫苗同时接种组成的对照方案进行了比较。
我们于1998年9月至1999年8月开展了一项随机双盲研究，以确定健康儿童接种新的五价联合DTPw-HB/Hib疫苗单剂进行初次和加强免疫接种的免疫原性和反应原性，并与对照方案进行比较。
两种疫苗接种方案均引发了良好的免疫反应，两组所有受试者在初次接种后1个月时抗PRP抗体浓度均达到≥0.15微克/毫升的血清保护水平。在所有抗原成分的血清保护/血清阳性/疫苗反应率方面，联合DTPw-HB/Hib疫苗不劣于已获许可的疫苗。两组在加强免疫接种时，针对所有研究疫苗抗原的抗体持久性相当，且加强剂量后所有抗体浓度均显著升高。两种疫苗接种方案的总体反应原性情况相似。
我们的结果表明，新的DTPw-HB/Hib五价联合疫苗为在全球范围内实施WHO关于控制乙肝和Hib感染的建议提供了一种有效且可靠的方式。
