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.
See: https://www.metabolomicsworkbench.org/about/howtocite.php
| 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 |
| 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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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 |
