Summary of Study ST000440

This data is available at the NIH Common Fund's National Metabolomics Data Repository (NMDR) website, the Metabolomics Workbench, https://www.metabolomicsworkbench.org, where it has been assigned Project ID PR000339. The data can be accessed directly via it's Project DOI: 10.21228/M81S4N This work is supported by NIH grant, U2C- DK119886.

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Study IDST000440
Study TitleMetabotypes of Subjects with Adverse Reactions Following Vaccination
Study TypeMetabolomic Profile of Human Serum
Study SummaryMetabolomics may help identify a particular metabolic signature “metabotype” in patients who are predisposed to developing AEFI such as a systemic reaction, or myocarditis that currently is difficult or impossible to identify prior to the development of the AEFI. This proposed pilot study looks at the metabolic profiles of a specific population of subjects who received the smallpox vaccine with or without other concomitantly administered vaccines to help determine if a unique metabotype can be identified in subjects who reported systemic reactions following immunization. In addition, this proposed study will look at the metabolic profile of several subjects with subclinical or clinically diagnosed myopericarditis to determine if these subjects have a unique metabotype. The ability to identify a unique metabotype would allow a clinician to potentially mitigate serious AEFI and ultimately improve the quality of immunization healthcare. If identified, these profiles might represent novel biomarkers of risk that can supplement existing clinical decision making for risk stratification or vaccine exemptions.
Institute
University of North Carolina
DepartmentRCMRC
LaboratorySumner Lab
Last NameSumner
First NameSusan
AddressEastern Regional Comprehensive Metabolomics Resource Core, UNC Nutrition Research Institute, 500 Laureate Way, Kannapolis, NC, 28081
Emailsusan_sumner @unc.edu
Phone704-250-5066
Submit Date2016-08-02
Num Groups4
Total Subjects200
Num Males190
Num Females10
Raw Data AvailableYes
Analysis Type DetailNMR
Release Date2016-09-23
Release Version1
Susan Sumner Susan Sumner
https://dx.doi.org/10.21228/M81S4N
ftp://www.metabolomicsworkbench.org/Studies/ application/zip

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Project:

Project ID:PR000339
Project DOI:doi: 10.21228/M81S4N
Project Title:Metabotypes of Subjects with Adverse Reactions Following Vaccination: A Pilot Study
Project Type:Metabolomic Profile of Human Serum
Project Summary:An Adverse Event Following Immunization (AEFI) is an adverse reaction to a vaccination that goes above and beyond the usual side effects that are known to be associated with vaccinations. AEFIs can vary in clinical severity to very mild to incapacitating and occasionally require lost time from work or even hospitalization. In rare cases, there is an aberrant immune reaction from vaccination resulting in a potentially serious adverse event. One known serious adverse event related to the smallpox vaccine is myocarditis and/or pericarditis (myopericarditis). Metabolomics may help identify a particular metabolic signature “metabotype” in patients who are predisposed to developing AEFI such as a systemic reaction, or myocarditis that currently is difficult or impossible to identify prior to the development of the AEFI. This proposed pilot study looks at the metabolic profiles of a specific population of subjects who received the smallpox vaccine with or without other concomitantly administered vaccines to help determine if a unique metabotype can be identified in subjects who reported systemic reactions following immunization. In addition, this proposed study will look at the metabolic profile of several subjects with subclinical or clinically diagnosed myopericarditis to determine if these subjects have a unique metabotype. The ability to identify a unique metabotype would allow a clinician to potentially mitigate serious AEFI and ultimately improve the quality of immunization healthcare. If identified, these profiles might represent novel biomarkers of risk that can supplement existing clinical decision making for risk stratification or vaccine exemptions.
Institute:Defense Health Agency - Immunization Healthcare Branch and Womack Army Medical Center
Department:Immunization
Last Name:McClenathan
First Name:Bruce
Address:1-2532 Armistead Street, Fort Bragg, NC 28310
Email:bruce.m.mcclenathan.civ@mail.mil
Phone:(910) 432-4015

Subject:

Subject ID:SU000461
Subject Type:Human
Subject Species:Homo sapiens
Taxonomy ID:9606
Species Group:Human

Factors:

Subject type: Human; Subject species: Homo sapiens (Factor headings shown in green)

mb_sample_id local_sample_id Gender Group Number
SA022149S_591 1
SA022150S_401 1
SA022151S_271 1
SA022152S_601 1
SA022153S_281 1
SA022154S_391 1
SA022155S_71 1
SA022156S_81 1
SA022157S_621 1
SA022158S_91 2
SA022159S_261 2
SA022160S_241 2
SA022161S_231 2
SA022162S_251 2
SA022163S_291 2
SA022164S_321 2
SA022165S_311 2
SA022166S_301 2
SA022167S_31 2
SA022168S_221 2
SA022169S_201 2
SA022170S_1881 2
SA022171S_1891 2
SA022172S_1871 2
SA022173S_181 2
SA022174S_171 2
SA022175S_1901 2
SA022176S_1911 2
SA022177S_21 2
SA022178S_331 2
SA022179S_1941 2
SA022180S_1931 2
SA022181S_1921 2
SA022182S_211 2
SA022183S_351 2
SA022184S_501 2
SA022185S_511 2
SA022186S_51 2
SA022187S_491 2
SA022188S_481 2
SA022189S_521 2
SA022190S_531 2
SA022191S_571 2
SA022192S_581 2
SA022193S_561 2
SA022194S_551 2
SA022195S_541 2
SA022196S_471 2
SA022197S_461 2
SA022198S_381 2
SA022199S_161 2
SA022200S_371 2
SA022201S_361 2
SA022202S_61 2
SA022203S_41 2
SA022204S_411 2
SA022205S_451 2
SA022206S_441 2
SA022207S_431 2
SA022208S_421 2
SA022209S_341 2
SA022210S_191 2
SA022211S_141 2
SA022212S_111 2
SA022213S_151 2
SA022214S_121 2
SA022215S_131 2
SA022216S_101 2
SA022217S_1061 3
SA022218S_1071 3
SA022219S_1091 3
SA022220S_1101 3
SA022221S_1081 3
SA022222S_1051 3
SA022223S_671 3
SA022224S_631 3
SA022225S_1031 3
SA022226S_1111 3
SA022227S_1041 3
SA022228S_651 3
SA022229S_1141 3
SA022230S_1211 3
SA022231S_1201 3
SA022232S_1221 3
SA022233S_1231 3
SA022234S_1241 3
SA022235S_1191 3
SA022236S_1181 3
SA022237S_681 3
SA022238S_1131 3
SA022239S_1151 3
SA022240S_1161 3
SA022241S_1171 3
SA022242S_1121 3
SA022243S_691 3
SA022244S_901 3
SA022245S_911 3
SA022246S_1001 3
SA022247S_891 3
SA022248S_871 3
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Collection:

Collection ID:CO000455
Collection Summary:Serum was collected in accordance with standard operating procedures.
Sample Type:Blood

Treatment:

Treatment ID:TR000475
Treatment Summary:Two-hundred sera samples – 100 baseline (pre-vaccine) and 100 post-smallpox vaccination

Sample Preparation:

Sampleprep ID:SP000468
Sampleprep Summary:A total of 200 study samples were thawed on ice for sample preparation, 400 uL of the thawed serum sample were transferred to labeled tubes on ice where they were mixed with 1200uL of MeOH. Analytical quality control (QC) phenotypic pooled samples (3/Group) were generated by transferring pre-determined volumes of each sample from each respective phenotypic Group’s experimental samples into four different 2.0 mL LoBind tubes. The Phenotypic Pool tubes were vortexed, and 3 aliquots of 400 uL was transferred to Phenotypic Pool tubes for each Group. In addition, a study pool was generated by transferring 200 uL of serum from 25 randomly selected experimental samples into a 10.0 mL tube, vortexed and aliquoted into 10 Study Pool tubes. Methanol was added to all tubes (1200 uL), sample tubes were vortexed for 2 min on a multi-tube vortexer and centrifuged at 16,000 rcf for 5 min. A 1000 µl aliquot of the supernatant was transferred into new pre-labeled 2.0 mL LoBind tubes and lyophilized to complete dryness overnight. Samples were reconstituted with 700 uL of NMR Master Mix solution containing Chenomx ISTD: DSS-d6 and D2O-Phosphate Buffer at 7.4 pH. The tubes were vortexed for 4 min on a multi-tube vortexer and centrifuged at 16,000 rcf for 5 min. A 600 uL of each sample supernatant was transferred into a pre-labeled 5mm 4 NMR tubes for data acquisition on a 700 MHz spectrometer.

Analysis:

Analysis ID:AN000691
Analysis Type:NMR
Num Factors:8

NMR:

NMR ID:NM000076
Analysis ID:AN000691
Instrument Name:Bruker
Instrument Type:FT-NMR
NMR Experiment Type:1D 1H
Field Frequency Lock:Deuterium
Standard Concentration:0.5mM
Spectrometer Frequency:700 MHz
NMR Probe:5mm ATMA Cryoprobe
NMR Solvent:D2O
NMR Tube Size:5mm
Shimming Method:Topshim
Water Suppression:yes
Receiver Gain:4.5
Offset Frequency:3299
Chemical Shift Ref Cpd:DSS
Temperature:298.1K
Number Of Scans:128
Dummy Scans:4
Acquisition Time:3.893s
Relaxation Delay:2s
Spectral Width:12.0277ppm
Num Data Points Acquired:65536
Real Data Points:65536
Line Broadening:0.5Hz
Zero Filling:yes
Apodization:Lorentzian
Baseline Correction Method:Polynomial
Chemical Shift Ref Std:DSS-d6
Binned Increment:0.04ppm
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