Dagan Ron, Juergens Christine, Trammel James, Patterson Scott, Greenberg David, Givon-Lavi Noga, Porat Nurith, Gruber William C, Scott Daniel A
The Faculty of Health Sciences, The Ben-Gurion University of the Negev, POB 653, Beer-Sheva 84105, Israel.
Pfizer Pharma GmbH, Linkstrasse 10, 10785 Berlin, Germany.
Vaccine. 2016 Aug 5;34(36):4313-20. doi: 10.1016/j.vaccine.2016.06.075. Epub 2016 Jul 12.
A prior 7- and 13-valent pneumococcal conjugate vaccine (PCV7 and PCV13) study provided sufficient data (N=1754; Jewish, n=1154; Bedouin, n=595; other, n=5) to investigate the association between nasopharyngeal (NP) acquisition of common PCV7 serotypes and cross-reacting 6A (PCV7+6A) and IgG concentrations.
Using a logistic regression model, serotype specific association between postinfant series IgG concentration (age 7months) and new NP acquisition between ages 7 and 24months was assessed and adjusted for ethnicity. From a subset of subjects with new NP acquisition (n=9-152 across serotypes studied), new acquisition percentiles and associated IgG concentrations were calculated.
For the serotypes studied, new NP acquisition rates decreased as IgG concentrations increased. Ethnicity did not influence these associations despite differences in carriage rates. From the subset with new acquisitions, 50% of the events occurred at IgG concentrations >0.61-5.58μg/mL; and 10% of the acquisitions occurred at IgG concentrations >2.48-17.69μg/mL.
Remarkably high IgG concentrations are required to reduce NP acquisition. These IgG concentrations differ between serotypes. Ethnicity did not influence the association between high IgG concentrations and prevention of carriage despite differences in carriage rates. Since carriage determines transmission, these results may have important implications for herd protection.
ClinicalTrials.gov number, NCT00508742; http://clinicaltrials.gov/ct2/show/NCT00508742.
先前一项关于7价和13价肺炎球菌结合疫苗(PCV7和PCV13)的研究提供了足够的数据(N = 1754;犹太人,n = 1154;贝都因人,n = 595;其他,n = 5),以研究常见PCV7血清型的鼻咽部(NP)获得与交叉反应性6A(PCV7 + 6A)及IgG浓度之间的关联。
使用逻辑回归模型,评估婴儿系列接种后(7个月龄)IgG浓度与7至24个月龄期间新的NP获得之间的血清型特异性关联,并根据种族进行调整。从新获得NP的受试者子集中(在所研究的血清型中n = 9 - 152),计算新获得的百分位数及相关的IgG浓度。
对于所研究的血清型,新的NP获得率随IgG浓度升高而降低。尽管携带率存在差异,但种族并未影响这些关联。在新获得NP的子集中,50%的事件发生在IgG浓度>0.61 - 5.58μg/mL时;10%的获得事件发生在IgG浓度>2.48 - 17.69μg/mL时。
需要非常高的IgG浓度才能降低NP获得。这些IgG浓度在不同血清型之间有所不同。尽管携带率存在差异,但种族并未影响高IgG浓度与预防携带之间的关联。由于携带决定传播,这些结果可能对群体保护具有重要意义。
ClinicalTrials.gov编号,NCT00508742;http://clinicaltrials.gov/ct2/show/NCT00508742 。