Systems Biology of Zoster Vaccine
Primary Purpose
Zoster, Zoster Varicella, Shingles
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Shingrix®
Sponsored by
About this trial
This is an interventional prevention trial for Zoster focused on measuring Zoster, Immune responses, Vaccine, Vaccine Trials, Clinical Trials, Chicken Pox, Shingles
Eligibility Criteria
Inclusion Criteria:
- Subject must be able to understand and provide informed consent.
- Adults aged 50-60 years, or community dwelling adults aged 70 years and above.
Exclusion Criteria:
- Inability or unwillingness of a subject to give written informed consent or comply with study protocol.
Receipt of immune products:
- Receipt of blood products within 6 months prior of the first dose of the study Zoster vaccine or expected receipt through 6 months after vaccination with the second dose of the study Zoster vaccine.
- Receipt of any vaccine within 4 weeks prior to vaccination with any of the two doses of the study Zoster vaccine or expected receipt within 4 weeks after vaccination with any of the two doses of the study Zoster vaccine.
- Receipt of any Zoster or varicella vaccines at any time prior to study entry.
- Subject taking any non-topical antiviral therapy with activity against herpes viruses, including but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir 3 days prior to each vaccination or 14 days after.
- Prior history of shingles.
Presence of certain co morbidities or immunosuppressive states such as:
- Chronic medical problems including (but not limited to) insulin-dependent diabetes, severe (at the discretion of the investigator or study physician) heart, lung, liver, or kidney diseases; auto immune diseases; severe gastrointestinal diseases; and uncontrolled hypertension.
- Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C, tuberculosis, organ transplant, cancer, current and or expected receipt of chemotherapy, radiation therapy, steroids [i.e., > 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days); (nasal (less than 1mg/day of fluticasone equivalent inhaled corticosteroid is allowable) and topical steroids are allowed)], antitumor necrosis factor agents, or any other immunosuppressive therapy, anatomic or functional asplenia, congenital immunodeficiency.
Conditions that could affect the safety of the subjects such as:
- Severe reactions to prior vaccinations.
- History of anaphylactic/anaphylactoid reaction to any component of the vaccines.
- History of bleeding disorders.
- Any acute illness, including any fever (> 100.4 F [> 38.0 C], regardless of the route) within 3 days prior to study entry.
- Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
- Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
- Use of investigational drugs within 12 months of participation.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator or study physician, may pose additional risks from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
- Women of childbearing potential.
Sites / Locations
- The Hope ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Younger Group
Older Group
Arm Description
Participants between the ages of 50 to 60 years will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®)
Participants who are ≥70 year old will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®)
Outcomes
Primary Outcome Measures
Change in innate immune signatures
Will be assessed between D0, D1, and D7 and each dose of Zoster vaccine recombinant, adjuvanted, in both age cohorts: 50-60 years and >70 years of age
Secondary Outcome Measures
Change in safety of Zoster vaccine recombinant, adjuvanted
Differences in related adverse events and serious adverse events between each dose of Zoster vaccine recombinant, adjuvanted, in both age cohorts.
Full Information
NCT ID
NCT04047979
First Posted
August 6, 2019
Last Updated
December 21, 2022
Sponsor
Emory University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT04047979
Brief Title
Systems Biology of Zoster Vaccine
Official Title
SHINGRIX-Systems Biology of Zoster Vaccine Recombinant, Adjuvanted
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to better understand how the immune system responds to the new herpes zoster (shingles) vaccine (Shingrix®). The study will be looking at certain markers in the blood after vaccination with Shingrix®.
Detailed Description
Varicella zoster virus (VZV) can cause two distinct diseases: chicken pox (varicella) and herpes zoster (shingles). The primary infection with VZV causes chicken pox, a widespread rash occurring with fever, mostly in childhood. The virus can then remain dormant in a person's body and has the ability to reactivate later in life causing shingles. Shingles is a painful rash, occurring mostly in older individuals or those who have a weakened immune system. After resolution of the rash, individuals may experience persistent pain in the same area, called post-herpetic neuralgia.
The purpose of the study is to better understand how the immune system responds to the new herpes zoster (shingles) vaccine (Shingrix®). In particular, looking at certain markers in the blood after vaccination with Shingrix®.
The study will be an open label randomized clinical trial in healthy older adults. There will be two groups of participants: those aged 50 to 60 years or those who are 70 years old and above, both groups will receive the vaccine. This will help compare the immune response to the herpes zoster vaccine in different age cohorts of older adults.
Subjects will be recruited by flyer advertisements. Interested individuals will be screened for the study and if they qualify they will be consented and enrolled in the study. Blood samples will be collected and banked. There are optional storage of data/specimens for future research including: being contacted for future studies, having contact information and limited medical information entered into a clinic database, and storage of Protected Health Information and samples for future research (yes, no, and de-identified)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zoster, Zoster Varicella, Shingles, Chicken Pox
Keywords
Zoster, Immune responses, Vaccine, Vaccine Trials, Clinical Trials, Chicken Pox, Shingles
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Single center, open label mechanistic study in which older adult subjects will receive Zoster vaccine recombinant, adjuvanted Vaccination will occur on Day 0 and Day 60. There will be no randomization, study participant or clinical study personnel blinding, or masking.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Younger Group
Arm Type
Experimental
Arm Description
Participants between the ages of 50 to 60 years will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®)
Arm Title
Older Group
Arm Type
Experimental
Arm Description
Participants who are ≥70 year old will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®)
Intervention Type
Biological
Intervention Name(s)
Shingrix®
Intervention Description
A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.
Primary Outcome Measure Information:
Title
Change in innate immune signatures
Description
Will be assessed between D0, D1, and D7 and each dose of Zoster vaccine recombinant, adjuvanted, in both age cohorts: 50-60 years and >70 years of age
Time Frame
Baseline, Days 1, 7, 60, 61, 67
Secondary Outcome Measure Information:
Title
Change in safety of Zoster vaccine recombinant, adjuvanted
Description
Differences in related adverse events and serious adverse events between each dose of Zoster vaccine recombinant, adjuvanted, in both age cohorts.
Time Frame
Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject must be able to understand and provide informed consent.
Adults aged 50-60 years, or community dwelling adults aged 70 years and above.
Exclusion Criteria:
Inability or unwillingness of a subject to give written informed consent or comply with study protocol.
Receipt of immune products:
Receipt of blood products within 6 months prior of the first dose of the study Zoster vaccine or expected receipt through 6 months after vaccination with the second dose of the study Zoster vaccine.
Receipt of any vaccine within 4 weeks prior to vaccination with any of the two doses of the study Zoster vaccine or expected receipt within 4 weeks after vaccination with any of the two doses of the study Zoster vaccine.
Receipt of any Zoster or varicella vaccines at any time prior to study entry.
Subject taking any non-topical antiviral therapy with activity against herpes viruses, including but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir 3 days prior to each vaccination or 14 days after.
Prior history of shingles.
Presence of certain co morbidities or immunosuppressive states such as:
Chronic medical problems including (but not limited to) insulin-dependent diabetes, severe (at the discretion of the investigator or study physician) heart, lung, liver, or kidney diseases; auto immune diseases; severe gastrointestinal diseases; and uncontrolled hypertension.
Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C, tuberculosis, organ transplant, cancer, current and or expected receipt of chemotherapy, radiation therapy, steroids [i.e., > 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days); (nasal (less than 1mg/day of fluticasone equivalent inhaled corticosteroid is allowable) and topical steroids are allowed)], antitumor necrosis factor agents, or any other immunosuppressive therapy, anatomic or functional asplenia, congenital immunodeficiency.
Conditions that could affect the safety of the subjects such as:
Severe reactions to prior vaccinations.
History of anaphylactic/anaphylactoid reaction to any component of the vaccines.
History of bleeding disorders.
Any acute illness, including any fever (> 100.4 F [> 38.0 C], regardless of the route) within 3 days prior to study entry.
Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
Use of investigational drugs within 12 months of participation.
Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator or study physician, may pose additional risks from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Women of childbearing potential.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadine Rouphael, MD
Phone
404-712-1435
Email
nroupha@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Rouphael, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hope Clinic
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadine Rouphael, MD
Phone
404-712-1435
Email
nroupha@emory.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
At the time of publication or 9 months after submission of the manuscript. It will be available indefinitely.
IPD Sharing Access Criteria
Data will be uploaded into www.immport.org and made available to researchers with a registered account.
Type of Analysis: Any Purpose
Mode of Access: Data will be shared on www.immport.org
IPD Sharing URL
http://www.immport.org
Learn more about this trial
Systems Biology of Zoster Vaccine
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