Evidence map›Paper›PMID 21285968›Full record

Trial reportEuropean journal of clinical nutrition2011

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

L E Davidson, A-M Fiorino, D R Snydman, P L Hibberd

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of clinical nutrition, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04884776 (Modulation of Gut Microbiota to Enhance Health and Immunity of Vulnerable Individuals During COVID-19 Pandemic), which is not on this map. Cited by 83 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 4 pooled it
9.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04884776 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Modulation of Gut Microbiota to Enhance Health and Immunity of Vulnerable Individuals During COVID-19 Pandemic

TypeinterventionalSponsorChinese University of Hong KongRan2021 to 2024Enrolled453ConditionsGut Microbiota, COVID-19 VaccineArmsMicrobiome immunity formula, Active placebo
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 4 syntheses or guidelines pooled it, 167 citations in OpenAlex.

  1. The effect of probiotics on respiratory tract infection with special emphasis on COVID-19: Systemic review 2010-20.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2021
    Pooled it
  2. Vaccines for preventing influenza in healthy adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Impact of oral administration of single strainFrontiers in immunology · 2022
    Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Review
  11. A Safe and Versatile Minicell Platform Derived fromJournal of microbiology and biotechnology · 2025
    Article
  12. Review
  13. Review
  14. Review
  15. Molecular Mechanisms ofMicroorganisms · 2024
    Review
  16. Article
  17. Review
  18. Review
  19. Article
  20. Consumption of yogurt fermented withBioscience of microbiota, food and health · 2023
    Article

23 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

L E DavidsonDivision of Geographic Medicine and Infectious Diseases, Department of Medicine, Tufts Medical Center, Boston, MA 02111, USA. ldavidson1@tuftsmedicalcenter.org
A-M Fiorino
D R Snydman
P L Hibberd
Tufts Medical Center · USMassachusetts General Hospital · US

Funding

TUFTS CLINICAL AND TRANSLATION SCIENCE INSTITUTE (UL1): BPCAUL1RR025752 · NCRR · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2008 to 2011
$17.6M
ZIDOVUDINE &LAMIVUDINE ALONE OR IN COMBINATION ON BODY COMPOSITIONM01RR000054 · NCRR · TUFTS MEDICAL CENTER · PI RAO, MADHUMATHI · 1985 to 2005
$12.2M
Midcareer Investigator Award in Patient-Oriented Research (K24)K24AT003683 · NCCIH · TUFTS MEDICAL CENTER · PI HIBBERD, PATRICIA L · 2006 to 2015
$1.9M
Clinical Research Training in Infectious DiseasesT32AI055412 · NIAID · TUFTS MEDICAL CENTER · PI SNYDMAN, DAVID RICHARD · 2005 to 2014
$1.3M
NCCIH NIH HHS K24 AT003683NCRR NIH HHS M01 RR000054NCRR NIH HHS M01RR00054NCRR NIH HHS UL1 RR025752NIAID NIH HHS T32 AI055412
6 · The paper itself

Abstract

BACKGROUND/

objectivesLive-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/

methodsWe 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.

resultsA 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).

conclusionLactobacillus 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.

Indexed as

Adjuvants, ImmunologicAdolescentAdultAntibodies, ViralDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleHemagglutination Inhibition TestsHumansInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza, HumanInfluenza VaccinesLactobacillusMalePilot ProjectsAdjuvants, ImmunologicAntibodies, ViralInfluenza VaccinesVaccines, Attenuated

Identifiers

PMID21285968
PMCPMC3071884
OpenAlexW2023196450

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.