Miao Yan, Mzolo Thembile, Pellegrini Michele
GSK, Amsterdam, The Netherlands.
GSK, Siena, Italy.
Infect Dis Ther. 2019 Sep;8(3):335-341. doi: 10.1007/s40121-019-00258-5. Epub 2019 Aug 3.
Vaccines against human papillomavirus (HPV), tetanus, diphtheria, pertussis (Tdap) and Neisseria meningitidis are widely recommended in adolescents. A phase-4 observer-blind study was performed to investigate the impact of concomitant administration of a quadrivalent HPV (HPV4) and Tdap vaccine with a quadrivalent meningococcal CRM-conjugate vaccine (MenACWY-CRM) in terms of immunogenicity against the different vaccine antigens and overall safety profile. Previous results showed that concomitant administration of the three vaccines did not impact the immunogenicity of Tdap and MenACWY, or safety. This article presents recently released HPV immunogenicity results.
Healthy adolescents aged 11-18 years (801) were randomized to receive either HPV4 + Tdap + MenACWY or HPV4 + Tdap + Placebo and two additional doses of HPV4 at 2 and 6 months after the first dose. Antibody responses to HPV types (HPV-6, -11, -16 and -18) were assessed at baseline and at 1 month post-full vaccination.
Post-third HPV4 dose, non-inferiority of immune responses to HPV4 + Tdap + MenACWY vs. HPV4 + Tdap + Placebo was demonstrated; the lower limits of two-sided 95% CIs of the between-group differences in seroconversion rates were > - 5% (non-inferiority margin) against each HPV type tested. Seroconversion rates ranged between 98.0% (HPV-6) and 99.7% (HPV-11 and HPV-18) in group HPV4 + Tdap + MenACWY and from 99.0% (HPV-11 and HPV-16) to 99.7% (HPV-6 and HPV-18) in group HPV4 + Tdap + Placebo.
Overall, these data support the concomitant administration of HPV4, Tdap and MenACWY-CRM in adolescents.
Novartis Vaccines and Diagnostics Inc., now part of the GSK group of companies.
ClinicalTrials.gov identifier, NCT01424644.
人乳头瘤病毒（HPV）、破伤风、白喉、百日咳（Tdap）和脑膜炎奈瑟菌疫苗在青少年中广泛推荐使用。开展了一项4期观察性盲法研究，以调查四价HPV（HPV4）和Tdap疫苗与四价脑膜炎球菌CRM结合疫苗（MenACWY-CRM）同时接种对不同疫苗抗原免疫原性和总体安全性的影响。先前的结果表明，三种疫苗同时接种不会影响Tdap和MenACWY的免疫原性或安全性。本文介绍了最近公布的HPV免疫原性结果。
将801名11至18岁的健康青少年随机分为两组，一组接受HPV4+Tdap+MenACWY，另一组接受HPV4+Tdap+安慰剂，并在首剂接种后2个月和6个月额外接种两剂HPV4。在基线和全程接种后1个月评估对HPV各型（HPV-6、-11、-16和-18）的抗体反应。
在第三次接种HPV4后，证明HPV4+Tdap+MenACWY组与HPV4+Tdap+安慰剂组的免疫反应具有非劣效性；针对每种检测的HPV型别，两组血清转化率差异的双侧95%置信区间下限均＞-5%（非劣效界值）。HPV4+Tdap+MenACWY组的血清转化率在98.0%（HPV-6）至99.7%（HPV-11和HPV-18）之间，HPV4+Tdap+安慰剂组在99.0%（HPV-11和HPV-16）至99.7%（HPV-6和HPV-18）之间。
总体而言，这些数据支持在青少年中同时接种HPV4、Tdap和MenACWY-CRM。
诺华疫苗和诊断公司，现属葛兰素史克集团公司。
ClinicalTrials.gov标识符，NCT01424644。
