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Lactobacillus GG as an immune adjuvant for live-attenuated influenza vaccine in healthy adults: a randomized double-blind placebo-controlled trial.

Abstract

BACKGROUND/OBJECTIVES

Live-attenuated influenza vaccine (LAIV) protects against influenza by mucosal activation of the immune system. Studies in animals and adults have demonstrated that probiotics improve the immune response to mucosally delivered vaccines. We hypothesized that Lactobacillus GG (LGG) would function as an immune adjuvant to increase rates of seroconversion after LAIV administration.

SUBJECTS/METHODS

We conducted a randomized double-blind placebo-controlled pilot study to determine whether LGG improved rates of seroconversion after administration of LAIV. We studied 42 healthy adults during the 2007-2008 influenza season. All subjects received LAIV and then were randomized to LGG or placebo, twice daily for 28 days. Hemagglutinin inhibition titers were assessed at baseline, at day 28 and at day 56 to determine the rates of seroconversion. Subjects were assessed for adverse events throughout the study period.

RESULTS

A total of 39 subjects completed the per-protocol analysis. Both LGG and LAIV were well tolerated. Protection rates against the vaccine H1N1 and B strains were suboptimal in subjects receiving LGG and placebo. For the H3N2 strain, 84% receiving LGG vs 55% receiving placebo had a protective titer 28 days after vaccination (odds of having a protective titer was 1.84 95% confidence interval 1.04-3.22, P=0.048).

CONCLUSION

Lactobacillus GG is potential as an important adjuvant to improve influenza vaccine immunogenicity. Future studies of probiotics as immune adjuvants might need to specifically consider examining vaccine-naïve or sero-negative subjects, target mucosal immune responses or focus on groups known to have poor response to influenza vaccines.

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  • Authors+Show Affiliations

    ,

    Division of Geographic Medicine and Infectious Diseases, Department of Medicine, Tufts Medical Center, Boston, MA 02111, USA. ldavidson1@tuftsmedicalcenter.org

    , ,

    Source

    MeSH

    Adjuvants, Immunologic
    Adolescent
    Adult
    Antibodies, Viral
    Double-Blind Method
    Drug-Related Side Effects and Adverse Reactions
    Female
    Hemagglutination Inhibition Tests
    Humans
    Influenza A Virus, H1N1 Subtype
    Influenza A Virus, H3N2 Subtype
    Influenza Vaccines
    Influenza, Human
    Lactobacillus
    Male
    Pilot Projects
    Probiotics
    Vaccines, Attenuated
    Young Adult

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    21285968

    Citation

    Davidson, L E., et al. "Lactobacillus GG as an Immune Adjuvant for Live-attenuated Influenza Vaccine in Healthy Adults: a Randomized Double-blind Placebo-controlled Trial." European Journal of Clinical Nutrition, vol. 65, no. 4, 2011, pp. 501-7.
    Davidson LE, Fiorino AM, Snydman DR, et al. Lactobacillus GG as an immune adjuvant for live-attenuated influenza vaccine in healthy adults: a randomized double-blind placebo-controlled trial. Eur J Clin Nutr. 2011;65(4):501-7.
    Davidson, L. E., Fiorino, A. M., Snydman, D. R., & Hibberd, P. L. (2011). Lactobacillus GG as an immune adjuvant for live-attenuated influenza vaccine in healthy adults: a randomized double-blind placebo-controlled trial. European Journal of Clinical Nutrition, 65(4), pp. 501-7. doi:10.1038/ejcn.2010.289.
    Davidson LE, et al. Lactobacillus GG as an Immune Adjuvant for Live-attenuated Influenza Vaccine in Healthy Adults: a Randomized Double-blind Placebo-controlled Trial. Eur J Clin Nutr. 2011;65(4):501-7. PubMed PMID: 21285968.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Lactobacillus GG as an immune adjuvant for live-attenuated influenza vaccine in healthy adults: a randomized double-blind placebo-controlled trial. AU - Davidson,L E, AU - Fiorino,A-M, AU - Snydman,D R, AU - Hibberd,P L, Y1 - 2011/02/02/ PY - 2011/2/3/entrez PY - 2011/2/3/pubmed PY - 2011/7/16/medline SP - 501 EP - 7 JF - European journal of clinical nutrition JO - Eur J Clin Nutr VL - 65 IS - 4 N2 - BACKGROUND/OBJECTIVES: Live-attenuated influenza vaccine (LAIV) protects against influenza by mucosal activation of the immune system. Studies in animals and adults have demonstrated that probiotics improve the immune response to mucosally delivered vaccines. We hypothesized that Lactobacillus GG (LGG) would function as an immune adjuvant to increase rates of seroconversion after LAIV administration. SUBJECTS/METHODS: We conducted a randomized double-blind placebo-controlled pilot study to determine whether LGG improved rates of seroconversion after administration of LAIV. We studied 42 healthy adults during the 2007-2008 influenza season. All subjects received LAIV and then were randomized to LGG or placebo, twice daily for 28 days. Hemagglutinin inhibition titers were assessed at baseline, at day 28 and at day 56 to determine the rates of seroconversion. Subjects were assessed for adverse events throughout the study period. RESULTS: A total of 39 subjects completed the per-protocol analysis. Both LGG and LAIV were well tolerated. Protection rates against the vaccine H1N1 and B strains were suboptimal in subjects receiving LGG and placebo. For the H3N2 strain, 84% receiving LGG vs 55% receiving placebo had a protective titer 28 days after vaccination (odds of having a protective titer was 1.84 95% confidence interval 1.04-3.22, P=0.048). CONCLUSION: Lactobacillus GG is potential as an important adjuvant to improve influenza vaccine immunogenicity. Future studies of probiotics as immune adjuvants might need to specifically consider examining vaccine-naïve or sero-negative subjects, target mucosal immune responses or focus on groups known to have poor response to influenza vaccines. SN - 1476-5640 UR - https://www.unboundmedicine.com/medline/citation/21285968/Lactobacillus_GG_as_an_immune_adjuvant_for_live_attenuated_influenza_vaccine_in_healthy_adults:_a_randomized_double_blind_placebo_controlled_trial_ L2 - http://dx.doi.org/10.1038/ejcn.2010.289 DB - PRIME DP - Unbound Medicine ER -