Evidence map›Paper›PMID 30686636›Full record

Trial reportVaccine2019

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

Tyler J Wildes, Adam Grippin, Henrietta Fasanya, Kyle A Dyson, Mark Brantly

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02097589 (The Effect of Short-term Atorvastatin Treatment on Immune Responses to Pneumovax 23), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 31% 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.

NCT02097589 phase1completednot on this map

The Effect of Short-term Atorvastatin Treatment on Immune Responses to Pneumovax 23

TypeinterventionalSponsorUniversity of FloridaRan2014 to 2014Enrolled33ConditionsHealthy ControlsArmsAtorvastatin, Pneumovax 23, Placebo (lactose pill)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Cholesterol-modifying drugs in COVID-19.Oxford open immunology · 2020
    Article
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

5 authors at 3 institutions in 1 country.

Tyler J WildesUniversity of Florida MD-PhD Program, College of Medicine, Gainesville, FL, USA; University of Florida Brain Tumor Immunotherapy Program, Preston A. Wells, Jr. Center for Brain Tumor Therapy, Lillian S. Wells Department of Neurosurgery, McKnight Brain Institute, University of Florida, Gainesville, FL, USA. Electronic address: twildes@ufl.edu.
Adam GrippinUniversity of Florida MD-PhD Program, College of Medicine, Gainesville, FL, USA; University of Florida Brain Tumor Immunotherapy Program, Preston A. Wells, Jr. Center for Brain Tumor Therapy, Lillian S. Wells Department of Neurosurgery, McKnight Brain Institute, University of Florida, Gainesville, FL, USA.
Henrietta FasanyaUniversity of Florida MD-PhD Program, College of Medicine, Gainesville, FL, USA; University of Florida Health Cancer Center, Department of Radiation Oncology, Gainesville, FL, USA.
Kyle A DysonUniversity of Florida MD-PhD Program, College of Medicine, Gainesville, FL, USA; University of Florida Brain Tumor Immunotherapy Program, Preston A. Wells, Jr. Center for Brain Tumor Therapy, Lillian S. Wells Department of Neurosurgery, McKnight Brain Institute, University of Florida, Gainesville, FL, USA.
Mark BrantlyUniversity of Florida MD-PhD Program, College of Medicine, Gainesville, FL, USA; University of Florida Division of Pulmonary and Critical Care Medicine, Gainesville, FL, USA.
Allen Institute for Brain Science · USUniversity of Florida · USUniversity of Florida Health · US

Funding

Using social networks to map and evaluate team science across CTSA hubsUL1TR001427 · NCATS · UNIVERSITY OF FLORIDA · PI MITCHELL, DUANE A. · 2015 to 2024
$37.2M
Together: Transforming and Translating Discovery to Improve HealthTL1TR001428 · NCATS · UNIVERSITY OF FLORIDA · PI MCCORMACK, WAYNE T. · 2015 to 2023
$3.9M
NCATS NIH HHS TL1 TR001428NCATS NIH HHS UL1 TR001427
6 · The paper itself

Abstract

backgroundThe 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.

methodsDouble-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.

resultsOf 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).

conclusionsAtorvastatin 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 registrationclinicaltrials.gov Identifier: NCT02097589.

Indexed as

Immunity, HumoralAdjuvants, ImmunologicAdultAntibodies, BacterialAntibody FormationAnticholesteremic AgentsAtorvastatinCytokinesDouble-Blind MethodFemaleHealthy VolunteersHumansMalePneumococcal VaccinesPneumonia, PneumococcalStreptococcus pneumoniae23-valent pneumococcal capsular polysaccharide vaccineAdjuvants, ImmunologicAntibodies, BacterialAnticholesteremic AgentsAtorvastatinCytokinesPneumococcal VaccinesAtorvastatinHealthy volunteersHumoral immunityPneumococcal pneumoniaVaccination

Identifiers

PMID30686636
PMCPMC6379110
OpenAlexW2912884963

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

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 Socratic graph.