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Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly

Primary Purpose

Shingles

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ZOSTAVAX
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Shingles focused on measuring shingles vaccine, immune responses

Eligibility Criteria

25 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Able to understand and give informed consent.
  • Immunocompetent subjects aged 25-40 years, or community dwelling subjects between the ages of 60-79.

Exclusion Criteria:

  • Young adults aged 25-40 years who are Varicella-Zoster virus seronegative or equivocal results (mean value OD for Varicella-Zoster virus IgG lower than 1.1 by commercial enzyme-linked immunosorbent assay (ELISA) (Hope Clinic: IgG VZV ELISAII-Wampole Laboratories®, NJ, USA- Vaccine Research Trials Center:: Liaison VZV IgG Assay, DiaSorin, Italy)
  • Receipt of immune products:

    • Receipt of blood products within 6 months prior to vaccination with Zoster vaccine or expected receipt through 6 months after vaccination with Zoster vaccine*
    • Receipt of any vaccine within 4 weeks prior to vaccination with Zoster vaccine or expected receipt within 4 weeks after vaccination with Zoster vaccine*
    • Receipt of Zoster vaccine 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 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 heart, lung, liver, or kidney diseases; auto immune diseases; severe gastrointestinal diseases; and uncontrolled hypertension.
    • 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.
    • 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 and topical steroids are allowed)],antitumor necrosis factor agents, or any other immunosuppressive therapy, anatomic or functional asplenia, congenital immunodeficiency.
    • Pregnant or breast-feeding women, or women expecting to conceive 30 days before and 90 days after vaccination**.
  • Conditions that could affect the safety of the volunteers such as:

    • Severe reactions to prior vaccinations.
    • History of anaphylactic/anaphylactoid reaction to gelatin, neomycin or any other component of the vaccine. Neomycin allergy manifested as contact dermatitis is not a contraindication to receiving this vaccine.
    • History of bleeding disorders
  • Any acute illness, including any fever (> 100.4 F [> 38.0C], 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.

Note:

*An individual who initially is excluded from study participation based on one or more of the time-limited exclusion criteria (e.g., acute illness, receipt or expected receipt of live or inactivated vaccines ) may be considered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria.

Subjects receiving > 20 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 months.

**Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 90 days after zoster vaccination.

Sites / Locations

  • University of Colorado
  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Older group

Younger group

Arm Description

Participants between the ages of 60-79

Participants between the ages of 25-40

Outcomes

Primary Outcome Measures

Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX
The primary outcomes will identify the number of participants with innate immunity signatures in the young and older groups that correlate with the T cell adaptive immunity responses after ZOSTAVAX

Secondary Outcome Measures

The Number of Participants With Innate Immune Signatures That Correlate With the B and T Cells Adaptive Immunity Responses After ZOSTAVAX
The number of participants with innate immune signatures in the young and old groups that correlate with the B and T cells adaptive immunity responses after ZOSTAVAX

Full Information

First Posted
April 6, 2011
Last Updated
January 19, 2016
Sponsor
Emory University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT01331161
Brief Title
Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly
Official Title
Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
October 2012 (Actual)

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

Data Monitoring Committee
No

5. Study Description

Brief Summary
Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population. In this trial, the investigators will study the immunologic differences of the FDA approved licensed shingles vaccine between a younger and an older group. Thirty three healthy volunteers between the ages of 25-40 and forty four healthy volunteers between the ages of 60-79 will be enrolled in the study. Each participant in the study will be given one shingles shot. Blood work will be obtained one month before vaccination, on the day of vaccination, one day, three days, seven days, fourteen days, one month, three months and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.
Detailed Description
RATIONALE: Zoster vaccine is known to induce diminished antigen-specific T cell responses and lower protection in the elderly. Here we hypothesize that this is due to intrinsic defects in innate responses to the live attenuated virus, which translates into sub-optimal functional adaptive immune responses. Therefore, early innate signatures of vaccination should correlate with, and predict the immunogenicity of Zoster vaccine in the young and elderly. STUDY DESIGN: Double center, open label study in which adult healthy volunteers will be vaccinated with Zoster vaccine. Blood samples will be collected on day D-30 (pre- vaccination) D0 (at vaccination) and D1, D3, D7, D14, D30, D90 and D180 (post vaccination) to study innate and adaptive immunity responses. Even though Zoster vaccine is considered safe, volunteers are asked to report and record any local or systemic AEs for 7 days post-vaccination. Also AEs will be reported for 30 days post-vaccination any SAE for 180 days post vaccination. AEs developing the day of the blood draw will also be reported

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shingles
Keywords
shingles vaccine, immune responses

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Older group
Arm Type
Experimental
Arm Description
Participants between the ages of 60-79
Arm Title
Younger group
Arm Type
Experimental
Arm Description
Participants between the ages of 25-40
Intervention Type
Biological
Intervention Name(s)
ZOSTAVAX
Other Intervention Name(s)
shingles vaccine
Intervention Description
shingles vaccine, one dose
Primary Outcome Measure Information:
Title
Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX
Description
The primary outcomes will identify the number of participants with innate immunity signatures in the young and older groups that correlate with the T cell adaptive immunity responses after ZOSTAVAX
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The Number of Participants With Innate Immune Signatures That Correlate With the B and T Cells Adaptive Immunity Responses After ZOSTAVAX
Description
The number of participants with innate immune signatures in the young and old groups that correlate with the B and T cells adaptive immunity responses after ZOSTAVAX
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to understand and give informed consent. Immunocompetent subjects aged 25-40 years, or community dwelling subjects between the ages of 60-79. Exclusion Criteria: Young adults aged 25-40 years who are Varicella-Zoster virus seronegative or equivocal results (mean value OD for Varicella-Zoster virus IgG lower than 1.1 by commercial enzyme-linked immunosorbent assay (ELISA) (Hope Clinic: IgG VZV ELISAII-Wampole Laboratories®, NJ, USA- Vaccine Research Trials Center:: Liaison VZV IgG Assay, DiaSorin, Italy) Receipt of immune products: Receipt of blood products within 6 months prior to vaccination with Zoster vaccine or expected receipt through 6 months after vaccination with Zoster vaccine* Receipt of any vaccine within 4 weeks prior to vaccination with Zoster vaccine or expected receipt within 4 weeks after vaccination with Zoster vaccine* Receipt of Zoster vaccine 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 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 heart, lung, liver, or kidney diseases; auto immune diseases; severe gastrointestinal diseases; and uncontrolled hypertension. 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. 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 and topical steroids are allowed)],antitumor necrosis factor agents, or any other immunosuppressive therapy, anatomic or functional asplenia, congenital immunodeficiency. Pregnant or breast-feeding women, or women expecting to conceive 30 days before and 90 days after vaccination**. Conditions that could affect the safety of the volunteers such as: Severe reactions to prior vaccinations. History of anaphylactic/anaphylactoid reaction to gelatin, neomycin or any other component of the vaccine. Neomycin allergy manifested as contact dermatitis is not a contraindication to receiving this vaccine. History of bleeding disorders Any acute illness, including any fever (> 100.4 F [> 38.0C], 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. Note: *An individual who initially is excluded from study participation based on one or more of the time-limited exclusion criteria (e.g., acute illness, receipt or expected receipt of live or inactivated vaccines ) may be considered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria. Subjects receiving > 20 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 months. **Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 90 days after zoster vaccination.
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
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States

12. IPD Sharing Statement

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Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly

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