Effect of atorvastatin on humoral immune response to 23-valent pneumococcal polysaccharide vaccination in healthy volunteers: The StatVax randomized clinical trial.

BACKGROUND: The immunomodulatory effects of statins on vaccine response remain uncertain. Therefore, the objective of this study was to determine if atorvastatin enhances pneumococcal-specific antibody titer following 23-valent pneumococcal polysaccharide vaccination. METHODS: Double-blind, placebo-controlled, single-center randomized clinical trial entitled StatVax. Subjects were enrolled between June and July 2014 and followed up through September 2014. 33 healthy volunteers signed informed consent after volunteer sampling. 11 participants were excluded; 22 healthy volunteers without prior pneumococcal vaccination were enrolled and completed the study. Participants were randomized to receive a 28-day course of 40 mg atorvastatin (n = 12) or matching lactose placebo (n = 10). On day 7 of treatment, Pneumovax 23 was administered intramuscularly. The primary outcome was fold change in total pneumococcal-specific antibody titer determined by a ratio of post-vaccination titer over baseline titer. Secondary outcomes included serotype-specific pneumococcal antibody titer, seroconversion, complete blood counts (CBC), erythrocyte sedimentation rate (ESR), and serum cytokine analysis. RESULTS: Of the 22 randomized patients (mean age, 23.86; SD, 4.121; 11 women [50%]), 22 completed the trial. Total anti-pneumococcal antibody titer in the atorvastatin group went from a baseline mean of 32.58 (SD, 15.96) to 147.7 (SD, 71.52) µg/mL at 21 days post-vaccination while titer in the placebo group went from a mean of 30.81 (SD, 13.04) to 104.4 (SD, 45) µg/mL. When comparing fold change between treatment groups, there was a significant increase in fold change of total anti-pneumococcal antibody titer in the atorvastatin group compared to the placebo group (2-way ANOVA, p = .0177). CONCLUSIONS: Atorvastatin enhances antigen-specific primary humoral immune response to a T cell-independent pneumonia vaccination. Pending confirmation by larger cohort studies of target populations, peri-vaccination conventional doses of statins can become a novel adjuvant for poorly-immunogenic polysaccharide-based vaccines. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02097589.

A randomized double-blind, placebo-controlled study to establish the effects of spirulina in elderly Koreans.

AIMS: This study was conducted to determine the antioxidant capacity, immunomodulatory and lipid-lowering effects of spirulina in healthy elderly subjects and to document the effectiveness of spirulina as a functional food for the elderly. METHODS: A randomized double-blind, placebo-controlled study was performed. The subjects were 78 individuals aged 60-87 years and were randomly assigned in a blinded fashion to receive either spirulina or placebo. The elderly were instructed to consume the spirulina or placebo at home, 8 g/day, for 16 consecutive weeks. RESULTS: In male subjects, a significant plasma cholesterol-lowering effect was observed after the spirulina intervention (p < 0.05). Spirulina supplementation resulted in a significant rise in plasma interleukin (IL)-2 concentration, and a significant reduction in IL-6 concentration. A significant time-by-treatment intervention for total antioxidant status was observed between spirulina and placebo groups (p < 0.05). In female subjects, significant increases in IL-2 level and superoxide dismutase activity were observed (p < 0.05) after spirulina supplementation. There were significant reductions in total cholesterol in female subjects. CONCLUSIONS: The results demonstrate that spirulina has favorable effects on lipid profiles, immune variables, and antioxidant capacity in healthy, elderly male and female subjects and is suitable as a functional food.