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

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.