A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.
R01
Pathogenic Exosomes During Herpes Zoster Mediate Increased Vascular Dementia Risk.
2 other identifiers
observational
375
1 country
2
Brief Summary
The purpose of this observational research study is to study if patients with herpes zoster, also known as Shingles, have a higher risk of vascular dysfunction (problems with blood vessels, including stroke) and vascular dementia (problems with mental decline as a result of decreased blood flow to the brain) compared to patients without herpes zoster. Patients are evaluated based on the group they are assigned too:
- Day 1 = 1st day presenting to clinic with acute zoster
- 7 days post zoster
- 1 month after Day 1
- 3 months after Day 1
- 6 months after Day 1
- 12 months after Day 1
- Control Group: individuals without herpes zoster o Day 1 (only 1 visit will be completed)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2025
CompletedFirst Submitted
Initial submission to the registry
March 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
December 11, 2025
December 1, 2025
4.5 years
March 24, 2025
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Analyze exosome content for known vascular damaging proteins/miRNAs from matched control and HZ individuals over a 12-month period.
Using mass spectrometry and small RNA sequencing, we will quantify abundance and temporal changes of exosomal proteins and miRNAs associated with vascular dysfunction, inflammation, coagulation, and stroke, then correlate analytes with clinical and laboratory features (anti-VZV IgG titers and IgM, complete blood counts, comprehensive metabolic panel, and aPTT/PT/INR). Enrichment analyses will be conducted on the network of exosomal proteins and miRNAs to uncover pathways and shared analytes associated with HZ, vascular dysfunction, and neurodegenerative processes.
From enrollment throughout the 5-year proposal period, occurring in a cyclical and overlapping manner.
Secondary Outcomes (1)
Determine the mechanism(s) in which non-infectious HZ exosomes promote vascular dysfunction.
From enrollment throughout the 5-year proposal period, occurring in a cyclical and overlapping manner.
Study Arms (2)
HZ (Herpes Zoster) Group
Participants with untreated acute herpes zoster outbreak.
Control Group
Participants without acute herpes zoster outbreak.
Eligibility Criteria
Each year, 50 control subjects and 25 zoster individuals will be recruited to provide blood samples for this study, as well as clinical and laboratory information. This study will recruit individuals reflective of the United States demographics: 58% white (non-Hispanic), 19% Hispanic, 12% Black/African American, 6% Asian, and 5% two or more races. Houston is the fourth most populous city in the United States and has a demographic breakdown and population pool conducive to reflect the United States population. We will aim to recruit the following annually for years 1-5: (1) of the 50 control subjects, 29 White (non-Hispanic), 10 Hispanic, 6 Black/African American, 3 Asian, 2 Other (two or more), and (2) of the 25 control subjects, 14 White (non-Hispanic), 5 Hispanic, 3 Black/African American, 2 Asian, 1 Other (two or more). Within each ethnic group, half will be women and half men.
You may qualify if:
- At the Screening Visit (Visit 1/Day 1), all participants must meet all the following criteria in order to be considered for participation in the study:
- Be a male or female ≥ 18 years of age.
- Present to clinic for routine dermatologic evaluation with or without rash.
- Are willing and able to complete study visits and procedures, and able to effectively communicate with the investigator and other study personnel.
- Have adequate venous access and are willing to undergo venipuncture for blood draws.
- Present with acute, vesicle-stage HZ that has not been treated with antiviral therapies
- Are willing and have reliable transportation to complete additional follow-up visits at 7 days, 1 month, 3 months, 6 months, and 12 months after initial visit for acute HZ.
You may not qualify if:
- At the Screening Visit (Visit 1/Day 1), participants meeting any of the following criteria will be excluded from participation in the study:
- Female individuals who are pregnant or breast-feeding.
- Receiving systemic or topical antivirals for varicella zoster virus (VZV).
- Sensitivity or allergy to systemic or topical antiviral medications for HZ.
- History of diagnosed HZ within the last 8 years.
- Received a HZ vaccine (e.g., Zostavax®/Shingrix®) within the last 8 years.
- Received any vaccinations within the last 3 months.
- Currently taking immunosuppressive therapies, including medications and radiation.
- Currently taking any anticoagulants.
- History of any coagulation disorder(s).
- History of end-stage renal disease or uremia.
- History of end-stage liver disease.
- History of HIV.
- Have had a COVID-19 infection in last 3 months.
- Any history of non-skin cancers within the last 3 months.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004, United States
Center for Clinical Studies, LTD. LLP
Webster, Texas, 77598, United States
Related Publications (6)
Richter ER, Dias JK, Gilbert JE 2nd, Atherton SS. Distribution of herpes simplex virus type 1 and varicella zoster virus in ganglia of the human head and neck. J Infect Dis. 2009 Dec 15;200(12):1901-6. doi: 10.1086/648474.
PMID: 19919304BACKGROUNDNagel MA, Rempel A, Huntington J, Kim F, Choe A, Gilden D. Frequency and abundance of alphaherpesvirus DNA in human thoracic sympathetic ganglia. J Virol. 2014 Jul;88(14):8189-92. doi: 10.1128/JVI.01070-14. Epub 2014 Apr 30.
PMID: 24789785BACKGROUNDMahalingam R, Wellish M, Wolf W, Dueland AN, Cohrs R, Vafai A, Gilden D. Latent varicella-zoster viral DNA in human trigeminal and thoracic ganglia. N Engl J Med. 1990 Sep 6;323(10):627-31. doi: 10.1056/NEJM199009063231002.
PMID: 2166914BACKGROUNDGilden DH, Rozenman Y, Murray R, Devlin M, Vafai A. Detection of varicella-zoster virus nucleic acid in neurons of normal human thoracic ganglia. Ann Neurol. 1987 Sep;22(3):377-80. doi: 10.1002/ana.410220315.
PMID: 2823688BACKGROUNDGershon AA, Chen J, Davis L, Krinsky C, Cowles R, Reichard R, Gershon M. Latency of varicella zoster virus in dorsal root, cranial, and enteric ganglia in vaccinated children. Trans Am Clin Climatol Assoc. 2012;123:17-33; discussion 33-5.
PMID: 23303966BACKGROUNDIadecola C. The pathobiology of vascular dementia. Neuron. 2013 Nov 20;80(4):844-66. doi: 10.1016/j.neuron.2013.10.008.
PMID: 24267647BACKGROUND
Biospecimen
Blood sample collection by venipuncture with butterfly needle collection kit; total blood volume collected at each visit is 20cc which is \<2 Tablespoons of blood.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Director
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2025
First Posted
March 30, 2025
Study Start
February 13, 2025
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
August 1, 2030
Last Updated
December 11, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
Direct identifiers such as name and initials will not be shared with those that conduct future research, unless required by law or patient safety. Personal Health Information may be shared with others for future research. Written authorization will be obtained from all participants in order to release this information to secondary researchers. All information shared with secondary researchers will be coded with the participant's PID, and every effort will be made to maintain the participant's confidentiality. Informed consent and HIPAA authorization will be obtained from all participants prior to collection of data and specimens. Those researchers involved in future research may receive medical history and study data, including demographics such as age, gender, race and ethnicity that are specific to the participant. Data and leftover samples will be coded and identified using a participant identification number (PID). Names and initials will not be shared.