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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05898464
Collaborator
National Medical Center, Seoul (Other), SMG-SNU Boramae Medical Center (Other)
100
Enrollment
2
Arms
34
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Recombinant zoster vaccination
 Phase 4

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 10 months after the second dose and safety.

  • An interim analysis is planned after the first approximately 30 participants of each group complete a visit 10 months after 2nd dose.

  • Evaluation for the safety is planned after the first approximately 10 participants of the HIV #2 arm complete a visit 10 months after 2nd dose.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Mar 31, 2026
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: HIV #1

CD4+ T cell count <300 cells/µL

Biological: Recombinant zoster vaccination
Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart
Active Comparator: HIV #2

CD4+ T cell count≥300 cells/µL

Biological: Recombinant zoster vaccination
Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart

Outcome Measures

Primary Outcome Measures

  1. Humoral immune response [1 month, 10 months after 2nd dose]

    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

  1. Cell-mediated immunogenicity [1 month, 10 months after 2nd dose]

    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.

  2. Differences in humoral immune response and cell mediated immunogenecity [1 month, 10 months after 2nd dose]

    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

  3. Grade 3/4 adverse events (AE) [Within 7 days (Day 0-6) after the first and second dose.]

    Solicited and unsolicited local and systemic adverse events occurring within 7 days after the first and second dose

  4. Any serious adverse events (SAEs) [Throughout the study period: Day 0~360 or termination, whichever came first]

    Any serious adverse events occurring throughout the study period

  5. Increase in HIV Viral Load or decrease in CD4+ T-cell Count [1 month after 2nd dose]

    Increase in HIV Viral Load by 0.5 log or more or decrease in CD4+ T-cell Count by 30% or more

  6. Any AIDS-defining disease [Within 3 months after 2nd dose]

    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);

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  • Have a medical condition that may cause immunosuppression (such as cancer, bone marrow transplant, organ transplant, or dialysis patients) or receiving treatment that causes immunosuppression (eg. Long-term use of glucocorticoids (20 mg or more per day for more than 3 months), monoclonal antibodies, or other treatments that may cause immunosuppression).

  • 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 28 days prior to and 28 days after receiving the study vaccine (with the exception of licensed influenza vaccines, which may be given 14 days prior to and 14 days after 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Seoul National University Hospital
  • National Medical Center, Seoul
  • SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Wan Beom Park, M.D., PhD., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wan Beom Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05898464
Other Study ID Numbers:
  • 2304-110-1426
First Posted:
Jun 12, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Wan Beom Park, Professor, Seoul National University Hospital
Recombinant zoster vaccine
Vaccination of people living with HIV
Additional relevant MeSH terms:
Herpes Zoster

Study Results

No Results Posted as of Jun 12, 2023