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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02654704
Other study ID # 15-1029F
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 2015
Est. completion date July 2020

Study information

Verified date July 2020
Source Michigan State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To follow longitudinally healthy and immune-compromised responses to pneumococcal vaccination, in 60+ individuals towards the development of personalized medicine implementation (minimum enrollments in 2 age categories: young adults[18-25], older adults [55+], within each category: 10+ healthy, 10+ asthma, 10+ immune-compromised [e.g. leukemia or autoimmune disorders]). The approach will profile thousands of molecular components utilizing high-throughput technologies and integrate these data to obtain personalized immune response to vaccination. The study will provide insights into immune response mechanisms specific to asthmatics, immune compromised and healthy individuals, as well as in response to vaccination. Additionally the differences in dynamic response across the two age groups will be investigated.


Description:

The primary investigation involves integrative multi-omics monitoring of individuals following their pneumonia vaccination over twelve time points. Genomic sequencing will be used to evaluate the volunteer's genomic risks based on variants with known disease association. Full transcriptome (via RNA-Sequencing), proteome and metabolome profiling (via mass spectrometry) will be performed per time-point. This will allow the dynamic monitoring of thousands of molecular components and their responses to vaccination, capturing both the initial innate response reaction in addition to the adaptive response and return to baseline. This study involves a simple blood draw, saliva collection, standard FDA-approved pneumococcal vaccine administration and Spirometry.


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Pneumococcal Vaccination
The individuals will be followed to observe their immune system activation, following their vaccination with the standard Pneumococcal Polysaccharide Vaccine (PPSV23) as approved by the FDA.

Locations

Country Name City State
United States Clinical and Translational Science Institute East Lansing Michigan

Sponsors (1)

Lead Sponsor Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chen R, Mias GI, Li-Pook-Than J, Jiang L, Lam HY, Chen R, Miriami E, Karczewski KJ, Hariharan M, Dewey FE, Cheng Y, Clark MJ, Im H, Habegger L, Balasubramanian S, O'Huallachain M, Dudley JT, Hillenmeyer S, Haraksingh R, Sharon D, Euskirchen G, Lacroute P, Bettinger K, Boyle AP, Kasowski M, Grubert F, Seki S, Garcia M, Whirl-Carrillo M, Gallardo M, Blasco MA, Greenberg PL, Snyder P, Klein TE, Altman RB, Butte AJ, Ashley EA, Gerstein M, Nadeau KC, Tang H, Snyder M. Personal omics profiling reveals dynamic molecular and medical phenotypes. Cell. 2012 Mar 16;148(6):1293-307. doi: 10.1016/j.cell.2012.02.009. — View Citation

Mias GI, Snyder M. Personal genomes, quantitative dynamic omics and personalized medicine. Quant Biol. 2013 Mar;1(1):71-90. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Integrated Omics profile The study will construct RNA-expression, protein profiles and small molecule profiles on immune cells as these change over time prior to and following immune activation by the vaccine. The collective temporal patterns will be used to classify immune response. The outcome measured is an updated integrative Personal Omics Profile as reported at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3341616/ . This is observational in nature to assess personalized medicine methodology for following immune response. Through study completion, an average of 2 years
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