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 ID	ST000440
Study Title	Metabotypes of Subjects with Adverse Reactions Following Vaccination
Study Type	Metabolomic Profile of Human Serum
Study Summary	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	University of North Carolina
Department	RCMRC
Laboratory	Sumner Lab
Last Name	Sumner
First Name	Susan
Address	Eastern Regional Comprehensive Metabolomics Resource Core, UNC Nutrition Research Institute, 500 Laureate Way, Kannapolis, NC, 28081
Email	susan_sumner @unc.edu
Phone	704-250-5066
Submit Date	2016-08-02
Num Groups	4
Total Subjects	200
Num Males	190
Num Females	10
Raw Data Available	Yes
Analysis Type Detail	NMR
Release Date	2016-09-23
Release Version	1

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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.

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.