Ryman Josiah, Weaver Jessica, Hu Tianyan, Weinberger Daniel M, Yee Ka Lai, Sachs Jeffrey R
Quantitative Pharmacology and Pharmacometrics, Merck & Co., Inc, Rahway, NJ, USA.
Center for Observational and Real-World Evidence, Merck & Co., Inc., Rahway, NJ, USA.
NPJ Vaccines. 2022 Nov 7;7(1):140. doi: 10.1038/s41541-022-00538-1.
The strength of the immune response, as measured by antibody concentrations, varies between pneumococcal conjugate vaccines (PCVs). Linking immunogenicity and effectiveness is necessary to assess whether changes in immune response from currently recommended PCVs to next-generation vaccines could impact effectiveness. Simulated reverse cumulative distribution curves were generated using published serotype-specific IgG concentrations with placebo or PCV7. This was combined with the published estimates of serotype-specific vaccine effectiveness of PCV7 against invasive pneumococcal disease to estimate the protective antibody concentration for each serotype in PCV7. Then, based on the published serotype-specific IgG concentrations in PCV13 recipients, reverse cumulative distribution curves were generated for the serotypes shared between PCV13 and PCV7. These estimated protective antibody concentration values were then used to predict the vaccine effectiveness of PCV13. The results were compared to published aggregate values for vaccine effectiveness. The aggregate median predicted vaccine effectiveness values were similar to previously reported observed values for the United Kingdom (93% versus 90%), Australia (71% versus 70%), and Germany (91% versus 90%). These results demonstrate that IgG concentrations of next-generation PCVs can be used to generate reliable estimates of vaccine effectiveness for serotypes shared with established PCVs.
通过抗体浓度衡量的免疫反应强度在肺炎球菌结合疫苗（PCV）之间存在差异。将免疫原性与有效性联系起来对于评估从当前推荐的PCV到下一代疫苗的免疫反应变化是否会影响有效性是必要的。使用已发表的与安慰剂或PCV7相关的血清型特异性IgG浓度生成模拟反向累积分布曲线。这与已发表的PCV7针对侵袭性肺炎球菌疾病的血清型特异性疫苗有效性估计值相结合，以估计PCV7中每种血清型的保护性抗体浓度。然后，根据PCV13接种者中已发表的血清型特异性IgG浓度，为PCV13和PCV7共有的血清型生成反向累积分布曲线。这些估计的保护性抗体浓度值随后用于预测PCV13的疫苗有效性。将结果与已发表的疫苗有效性汇总值进行比较。汇总的预测疫苗有效性中位数与英国（93%对90%）、澳大利亚（71%对70%）和德国（91%对90%）先前报告的观察值相似。这些结果表明，下一代PCV的IgG浓度可用于生成与现有PCV共有的血清型的疫苗有效性的可靠估计值。
