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Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV

Primary Purpose

Vaccination; Infection, Vaccine Adverse Reaction

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Recombinant zoster vaccination
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaccination; Infection focused on measuring Recombinant zoster vaccine, Vaccination of people living with HIV

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 19 years old or older, HIV-1 infected person who have voluntarily agreed to participate in the study. Have been taking antiviral medications stably for at least one month at the time of screening. Have a CD4+ T-cell count measured within one month of screening. Do not have AIDS-defining diseases (excluding oral thrush) or acute/uncontrolled opportunistic infection at the time of enrollment. Do not have uncontrolled chronic medical conditions other than HIV infection. Exclusion Criteria: Have received any type of zoster vaccine within 1 year. Have been diagnosed with chickenpox or shingles within 12 months. Have a history of severe allergy to any of the components of Shingrix vaccine. Have a acute medical condition at the time of screening. Unable to be evaluated for adverse events via telephone contact after vaccination. Pregnant (including those planning to become pregnant) or lactating women. Those who have received chemotherapy or radiotherapy within 6 months prior to the first vaccine dose. Chronic administration of immunosuppressive or other immune-modifying drugs within 6 months prior to ther first vaccine dose. Administration of immunoglobulins, and/or any blood products within 3 months preceding the first dose of study vaccine Have a medical condition that makes receiving an intramuscular injection medically contraindicated. Have a disease or condition that may affect the immunogenicity or safety of the vaccine. Receiving any other vaccine within 14 days prior to and 14 days after receiving the study vaccine. Participate in a clinical trial that involves other investigational product or device during the course of the study. Any other person who, in the opinion of the investigator, is unsuitable for immune response assessment.

Sites / Locations

  • Seoul National University HospitalRecruiting
  • National Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HIV #1

HIV #2

Arm Description

CD4+ T cell count <300 cells/µL

CD4+ T cell count≥300 cells/µL

Outcomes

Primary Outcome Measures

Humoral immune response
Defined as a 4-fold or greater increase in anti-VZV antibody concentration from pre-vaccination testing in seropositive subjects and a 4-fold or greater increase in anti-gE antibody concentration from the cutoff in seronegative subjects prior to vaccination.

Secondary Outcome Measures

Cell-mediated immunogenicity
Defined as a 2-fold or greater increase in CD4+ T cells expressing at least two activation markers (i.e. CD40L, IFN-gamma, IL-2 or TNF-alpha) post-vaccination compared to pre-vaccination baseline.
Differences in humoral immune response and cell mediated immunogenecity
Comparison of geometric mean of anti VZV IgG titer and proportions of VZV-specific CD4+ and CD8+ T-cells between HIV#1 and HIV#2
Grade 3/4 adverse events (AE)
Solicited and unsolicited local and systemic adverse events occurring within 7 days after the first and second dose
Any serious adverse events (SAEs)
Any serious adverse events occurring throughout the study period
Increase in HIV Viral Load or decrease in CD4+ T-cell Count
Increase in HIV Viral Load by 0.5 log or more or decrease in CD4+ T-cell Count by 30% or more
Any AIDS-defining disease
Occurrence of any AIDS defining condition according to the appendix of the "Revised surveillance case definition for HIV infection--United States, 2014" (Centers for Disease Controls and Prevention);

Full Information

First Posted
May 30, 2023
Last Updated
September 19, 2023
Sponsor
Seoul National University Hospital
Collaborators
National Medical Center, Seoul, SMG-SNU Boramae Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05898464
Brief Title
Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV
Official Title
Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
National Medical Center, Seoul, SMG-SNU Boramae Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
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 this study is to compare the immunogenicity and safety of recombinant zoster vaccine according to CD4+ T-cell count and age in people living with HIV, and to provide evidence to guide immunization of people living with HIV.
Detailed Description
HIV-infected individuals willing to receive recombinant zoster vaccine will be recruited at three study hospitals. Participants are divided into two groups based on CD4+ T cell count (HIV #1: CD4+ T cell count <300 cells/µL, HIV #2: CD4+ T cell count≥300 cells/µL). Target numbers are 50 and 50, respectively. Give 2 intramuscular doses of recombinant zoster vaccine 2 months apart. Contact by phone on days 3 and 7 after each dose to assess for adverse events. Evaluate immunogenicity at 1 month and 13 months after the second dose and safety. An interim analysis is planned after the first approximately 30 participants of each group complete a visit 13 months after 2nd dose. Evaluation for the safety is planned after the first approximately 10 participants of the HIV #2 arm complete a visit 13 months after 2nd dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccination; Infection, Vaccine Adverse Reaction
Keywords
Recombinant zoster vaccine, Vaccination of people living with HIV

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIV #1
Arm Type
Experimental
Arm Description
CD4+ T cell count <300 cells/µL
Arm Title
HIV #2
Arm Type
Active Comparator
Arm Description
CD4+ T cell count≥300 cells/µL
Intervention Type
Biological
Intervention Name(s)
Recombinant zoster vaccination
Intervention Description
Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart
Primary Outcome Measure Information:
Title
Humoral immune response
Description
Defined as a 4-fold or greater increase in anti-VZV antibody concentration from pre-vaccination testing in seropositive subjects and a 4-fold or greater increase in anti-gE antibody concentration from the cutoff in seronegative subjects prior to vaccination.
Time Frame
1 month, 13 months after 2nd dose
Secondary Outcome Measure Information:
Title
Cell-mediated immunogenicity
Description
Defined as a 2-fold or greater increase in CD4+ T cells expressing at least two activation markers (i.e. CD40L, IFN-gamma, IL-2 or TNF-alpha) post-vaccination compared to pre-vaccination baseline.
Time Frame
1 month, 13 months after 2nd dose
Title
Differences in humoral immune response and cell mediated immunogenecity
Description
Comparison of geometric mean of anti VZV IgG titer and proportions of VZV-specific CD4+ and CD8+ T-cells between HIV#1 and HIV#2
Time Frame
1 month, 13 months after 2nd dose
Title
Grade 3/4 adverse events (AE)
Description
Solicited and unsolicited local and systemic adverse events occurring within 7 days after the first and second dose
Time Frame
Within 7 days (Day 0-6) after the first and second dose.
Title
Any serious adverse events (SAEs)
Description
Any serious adverse events occurring throughout the study period
Time Frame
Throughout the study period: Day 0~450 or termination, whichever came first
Title
Increase in HIV Viral Load or decrease in CD4+ T-cell Count
Description
Increase in HIV Viral Load by 0.5 log or more or decrease in CD4+ T-cell Count by 30% or more
Time Frame
1 month after 2nd dose
Title
Any AIDS-defining disease
Description
Occurrence of any AIDS defining condition according to the appendix of the "Revised surveillance case definition for HIV infection--United States, 2014" (Centers for Disease Controls and Prevention);
Time Frame
Within 3 months after 2nd dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 19 years old or older, HIV-1 infected person who have voluntarily agreed to participate in the study. Have been taking antiviral medications stably for at least one month at the time of screening. Have a CD4+ T-cell count measured within one month of screening. Do not have AIDS-defining diseases (excluding oral thrush) or acute/uncontrolled opportunistic infection at the time of enrollment. Do not have uncontrolled chronic medical conditions other than HIV infection. Exclusion Criteria: Have received any type of zoster vaccine within 1 year. Have been diagnosed with chickenpox or shingles within 12 months. Have a history of severe allergy to any of the components of Shingrix vaccine. Have a acute medical condition at the time of screening. Unable to be evaluated for adverse events via telephone contact after vaccination. Pregnant (including those planning to become pregnant) or lactating women. Those who have received chemotherapy or radiotherapy within 6 months prior to the first vaccine dose. Chronic administration of immunosuppressive or other immune-modifying drugs within 6 months prior to ther first vaccine dose. Administration of immunoglobulins, and/or any blood products within 3 months preceding the first dose of study vaccine Have a medical condition that makes receiving an intramuscular injection medically contraindicated. Have a disease or condition that may affect the immunogenicity or safety of the vaccine. Receiving any other vaccine within 14 days prior to and 14 days after receiving the study vaccine. Participate in a clinical trial that involves other investigational product or device during the course of the study. Any other person who, in the opinion of the investigator, is unsuitable for immune response assessment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wan Beom Park, M.D., PhD.
Phone
82-2-2072-3596
Email
wbpark1@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyeon Jae Jo, M.D.
Phone
82-2-2072-2503
Email
seth959@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan Beom Park, M.D., PhD.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Beom Park, M.D., Ph.D.
Email
wbpark1@snu.ac.kr
Facility Name
National Medical Center
City
Seoul
ZIP/Postal Code
04564
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min-Kyung Kim, M.D., MPH
Email
mkkim@nmc.or.kr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not planning to share IPDs publically, but de-identified individual participant data for all outcome measures could be shared with other researchers under their request.
Citations:
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Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV

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