Nurkka Anu, Joensuu Jaana, Henckaerts Isabelle, Peeters Pascal, Poolman Jan, Kilpi Terhi, Käyhty Helena
National Public Health Institute, Helsinki, Finland.
Pediatr Infect Dis J. 2004 Nov;23(11):1008-14. doi: 10.1097/01.inf.0000143640.03214.18.
Development is ongoing to increase the serotype coverage of pneumococcal conjugate vaccines. We report here the immunogenicity and safety of a new 11-valent pneumococcal conjugate vaccine (Pn-PD) in infants.
In a randomized, single blind study, 154 Finnish infants received 1 of 3 regimens: 4 doses of Pn-PD at 2, 4, 6 and 12-15 months; 3 doses of the Pn-PD at 2, 4 and 6 months and 1 dose of 23-valent polysaccharide vaccine (PncPS) at 12-15 months; or 3 doses of the hepatitis B vaccine at 2, 4 and 6 months and Pn-PD at 12-15 months. Serum IgG antibodies to vaccine serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F were measured with an enzyme immunoassay at the ages of 2, 7 and 12-15 months and at 4 or 28 days after the last vaccination. Local and systemic reactions were recorded by parents during 8 days after each dose. Serious adverse reactions were recorded during the entire study period.
There was a significant increase in the IgG concentrations to vaccine serotypes after 3 doses of Pn-PD. Antibody concentrations after the primary series varied between 1.26 and 4.92 microg/ml depending on the serotype and study group. PncPS vaccine induced a better booster response than the Pn-PD, measured at 28 days after the fourth dose. IgG concentrations after the Pn-PD booster ranged between 1.60 and 9.63 microg/ml and after the PncPS booster between 4.24 and 40.54 microg/ml, depending on the serotype. The antibody concentrations after the first dose of Pn-PD administered at 12-15 months increased significantly but were lower than after the fourth dose at the same age. No significant antibody increase was measured 4 days after the vaccinations at 12-15 months. The safety profile of the vaccine was acceptable.
The Pn-PD we tested was immunogenic and safe in infants.
增加肺炎球菌结合疫苗血清型覆盖率的研发工作正在进行。我们在此报告一种新型11价肺炎球菌结合疫苗（Pn-PD）在婴儿中的免疫原性和安全性。
在一项随机、单盲研究中，154名芬兰婴儿接受3种方案中的一种：在2、4、6和12 - 15月龄接种4剂Pn-PD；在2、4和6月龄接种3剂Pn-PD，并在12 - 15月龄接种1剂23价多糖疫苗（PncPS）；或在2、4和6月龄接种3剂乙肝疫苗，并在12 - 15月龄接种Pn-PD。在2、7和12 - 15月龄以及最后一剂疫苗接种后4或28天，采用酶免疫测定法检测针对疫苗血清型1、3、4、5、6B、7F、9V、14、18C、19F和23F的血清IgG抗体。家长在每次接种后8天记录局部和全身反应。在整个研究期间记录严重不良反应。
3剂Pn-PD接种后，针对疫苗血清型的IgG浓度显著增加。根据血清型和研究组不同，基础免疫系列后的抗体浓度在1.26至4.92微克/毫升之间。在第四剂接种后28天测量，PncPS疫苗诱导的加强免疫反应优于Pn-PD。根据血清型不同，Pn-PD加强免疫后的IgG浓度在1.60至9.63微克/毫升之间，PncPS加强免疫后的IgG浓度在4.24至40.54微克/毫升之间。在12 - 15月龄接种第一剂Pn-PD后，抗体浓度显著增加，但低于同年龄第四剂接种后的浓度。在12 - 15月龄接种疫苗后4天未检测到抗体显著增加。该疫苗的安全性良好。
我们测试的Pn-PD在婴儿中具有免疫原性且安全。
