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评估CECT5711菌株作为疫苗接种过程中的佐剂:一项针对健康成年人的随机临床试验。

Evaluation of CECT5711 strain as a coadjuvant in a vaccination process: a randomised clinical trial in healthy adults.

作者信息

Redondo Noemí, Nova Esther, Gheorghe Alina, Díaz Ligia Esperanza, Hernández Aurora, Marcos Ascensión

机构信息

Immunonutrition Group (Metabolism and Nutrition Department) - Institute of Food Science, Technology and Nutrition, Spanish National Research Council (ICTAN-CSIC), José Antonio Novais St. 10, 28040 Madrid, Spain.

出版信息

Nutr Metab (Lond). 2017 Jan 5;14:2. doi: 10.1186/s12986-016-0154-2. eCollection 2017.

DOI:10.1186/s12986-016-0154-2
PMID:28070204
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5217323/
Abstract

BACKGROUND

Although the effects of probiotics on the immune system have been extensively evaluated under disease states, their role in healthy situations remains unclear, since changes are hardly expected under immunological homeostasis. EFSA indicates that vaccination protocols could be used to evaluate the potential role of probiotics to improve the immune response against antigen challenges. The aim of the study was to evaluate the effect of CECT5711 (Lc) on the specific immunity of healthy volunteers undergoing vaccination with Hepatitis A virus (HAV).

METHODS

One hundred twenty-three healthy adults were randomised into three groups to follow a 6-week (wk) intervention and all received an intramuscular HAV vaccine 2 weeks after starting the intervention: 1) PRO1 received Lc for 2weeks (1 capsule/day; 3 × 10 CFU/capsule) and placebo capsules after vaccination; 2) PRO2 received a daily capsule of Lc (3 × 10 cfu/day) before and after the challenge; 3) Control group (C) received a daily placebo capsule before and after the vaccine. Blood samples were collected at the beginning (visit 1; V1) and after 2 (V2) and 6 weeks (V3) of the intervention. At each visit, lymphocyte subset counts and cytokine levels were analysed. Specific HAV antibodies were analysed at V1 and V3. To evaluate differences between groups, one-way ANOVA with Bonferroni post-hoc test were used regarding lymphocyte subset counts and specific HAV antibodies production, and Friedman test of related samples and Kendall concordance coefficient for cytokines production. Chi square test was used to analyse seroconversion rates.

RESULTS

Specific HAV antibodies were significantly higher in PRO1 (50.54 ± 29.57) compared to C (36.23 ± 16.45) ( = 0.017) and showed an intermediate value in PRO2 (41.61 ± 15.74). Seroconversion rates were similar in the three groups (97.3, 92.3 and 97.4% in C, PRO1 and PRO2 respectively). Memory T-helper lymphocytes increased in V3 vs. V1 ( = 0.032) in PRO2. No differences were found in cytokine concentrations.

CONCLUSION

Mixed results have been found regarding the usefulness of Lc supplementation to increase the antigen-specific antibody response to an immune challenge. Clinical trial registration number: EudraCT Number 2016-000183-42. Registered 19 January 2016. Retrospectively registered.

摘要

背景

尽管益生菌对免疫系统的影响已在疾病状态下得到广泛评估,但其在健康状况下的作用仍不明确,因为在免疫稳态下几乎不会出现变化。欧洲食品安全局指出,疫苗接种方案可用于评估益生菌在改善针对抗原刺激的免疫反应方面的潜在作用。本研究的目的是评估CECT5711(Lc)对接种甲型肝炎病毒(HAV)疫苗的健康志愿者特异性免疫的影响。

方法

123名健康成年人被随机分为三组,进行为期6周的干预,并在开始干预2周后均接受肌肉注射HAV疫苗:1)PRO1组在接种疫苗后接受2周的Lc(1粒胶囊/天;3×10⁹CFU/胶囊)和安慰剂胶囊;2)PRO2组在刺激前后每天接受1粒Lc胶囊(3×10⁹CFU/天);3)对照组(C)在接种疫苗前后每天接受1粒安慰剂胶囊。在干预开始时(访视1;V1)以及干预2周(V2)和6周(V3)后采集血样。每次访视时,分析淋巴细胞亚群计数和细胞因子水平。在V1和V3时分析特异性HAV抗体。为评估组间差异,对淋巴细胞亚群计数和特异性HAV抗体产生采用单向方差分析及Bonferroni事后检验,对细胞因子产生采用相关样本的Friedman检验和Kendall一致性系数。采用卡方检验分析血清转化率。

结果

与C组(36.23±16.45)相比,PRO1组的特异性HAV抗体显著更高(50.54±29.57)(P = 0.017),PRO2组呈现中间值(41.61±15.74)。三组的血清转化率相似(C组、PRO1组和PRO2组分别为97.3%、92.3%和97.4%)。PRO2组中,V3时记忆辅助性T淋巴细胞相对于V1增加(P = 0.032)。细胞因子浓度未发现差异。

结论

关于补充Lc以增加对免疫刺激的抗原特异性抗体反应的有效性,研究结果不一。临床试验注册号:EudraCT编号2016 - 000183 - 42。于2016年1月19日注册。回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf7f/5217323/0513871589fd/12986_2016_154_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf7f/5217323/0513871589fd/12986_2016_154_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf7f/5217323/0513871589fd/12986_2016_154_Fig1_HTML.jpg

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