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.
* HIV-infected individuals willing to receive recombinant zoster vaccine will be recruited at three study hospitals. * Participants are divided into two groups based on HIV status and CD4+ T cell count (HIV #1: CD4+ T cell count \<300 cells/µL, HIV #2: CD4+ T cell count≥300 cells/µL, non-HIV). * Target numbers are 50 for each group. * 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 HIV group and 10 participants of non-HIV 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart
Seoul National University Hospital
Seoul, South Korea
National Medical Center
Seoul, South Korea
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.
Time frame: 1 month, 13 months after 2nd dose
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.
Time frame: 1 month, 13 months after 2nd dose
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
Time frame: 1 month, 13 months after 2nd dose
Grade 3/4 adverse events (AE)
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.
Any serious adverse events (SAEs)
Any serious adverse events occurring throughout the study period
Time frame: Throughout the study period: Day 0~450 or termination, whichever came first
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
Time frame: 1 month after 2nd dose
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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);
Time frame: Within 3 months after 2nd dose