Rojas Olga Lucía, Caicedo Liliana, Guzmán Carolina, Rodríguez Luz-Stella, Castañeda Javier, Uribe Liliana, Andrade Yohanna, Pinzón Ricardo, Narváez Carlos Fernando, Lozano Juan Manuel, De Vos Beatrice, Franco Manuel A, Angel Juana
Instituto de Genética Humana, Colombia.
Viral Immunol. 2007 Summer;20(2):300-11. doi: 10.1089/vim.2006.0105.
In a double blind trial, 319 fully immunized children received two doses of either placebo or 10(6.7) focus-forming units of the attenuated RIX4414 human rotavirus (RV) vaccine ("all-in-one" formulation). Plasma RV-specific IgA (RV IgA), stool RV IgA, and circulating total and RV memory B cells (CD19+ IgD+/- CD27+) with an intestinal homing phenotype (alpha4beta7+ CCR9+/-) were measured, after the first and second doses, as potential correlates of protection. After the first and/or second dose, 54% of vaccinees and 13% of placebo recipients had plasma RV IgA. Before vaccination, most (95%) of the children (of both study groups) were breast-fed and had stool RV IgA (68.64%). Coproconversion (4-fold increase) after the first and/or second dose was observed in 32.7% of vaccinees and 17.4% of placebo recipients. No significant difference was seen when comparing the frequencies of any subset of memory B cells between vaccinees and placebo recipients. Statistically significant weak correlations were found between plasma RV IgA titers and coproconversion, and several subsets of memory B cells. The vaccine provided 74.8% protection (95% confidence interval, 30.93-92.62) against any RV gastroenteritis and 100% protection (95% confidence interval, 14.53-100) against severe RV gastroenteritis. When vaccinees and placebo recipients were considered together, a correlation was found between protection from disease and plasma RV IgA measured after dose 2 and RV memory (IgD- CD27+ alpha4beta7+ CCR9+) circulating B cells measured after dose 1. However, the correlation coefficients for both tests were low (<0.2), suggesting that other factors are important in explaining protection from disease.
在一项双盲试验中，319名完全免疫的儿童接受了两剂安慰剂或10(6.7)蚀斑形成单位的减毒RIX4414人轮状病毒（RV）疫苗（“一体化”制剂）。在第一剂和第二剂之后，测量血浆RV特异性IgA（RV IgA）、粪便RV IgA以及具有肠道归巢表型（α4β7+ CCR9+/-）的循环总记忆B细胞和RV记忆B细胞（CD19+ IgD+/- CD27+），作为潜在的保护相关性指标。在第一剂和/或第二剂之后，54%的疫苗接种者和13%的安慰剂接受者有血浆RV IgA。接种疫苗前，大多数（95%）儿童（两个研究组）进行母乳喂养且有粪便RV IgA（68.64%）。在32.7%的疫苗接种者和17.4 %的安慰剂接受者中观察到第一剂和/或第二剂后的粪便转化（4倍增加）。比较疫苗接种者和安慰剂接受者之间记忆B细胞任何亚群的频率时，未发现显著差异。在血浆RV IgA滴度与粪便转化以及几个记忆B细胞亚群之间发现了具有统计学意义的弱相关性。该疫苗对任何RV胃肠炎提供了74.8%的保护（95%置信区间，30.93 - 92.62），对严重RV胃肠炎提供了100%的保护（95%置信区间，14.53 - 100）。当将疫苗接种者和安慰剂接受者一起考虑时，发现疾病保护与第二剂后测量的血浆RV IgA以及第一剂后测量的RV记忆（IgD- CD27+ α4β7+ CCR9+）循环B细胞之间存在相关性。然而，两项检测的相关系数均较低（<0.2），表明其他因素在解释疾病保护方面很重要。
