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

Phase 4

Recruiting

• Conditions: Vaccination; Infection; Vaccine Adverse Reaction
• Interventions: Biological: Recombinant zoster vaccination

• Registration Number: NCT05898464
• Lead Sponsor: Seoul National University Hospital

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 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 Timeline

• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-12
• Study Start: 2023-06-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-HIV	Recombinant zoster vaccination	Healthy adult
HIV #2	Recombinant zoster vaccination	CD4+ T cell count≥300 cells/µL
HIV #1	Recombinant zoster vaccination	CD4+ T cell count \<300 cells/µL

Primary Outcome Measures

Name	Time	Method
Humoral immune response	1 month, 13 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

Name	Time	Method
Cell-mediated immunogenicity	1 month, 13 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.
Differences in humoral immune response and cell mediated immunogenecity	1 month, 13 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
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
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);
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
Any serious adverse events (SAEs)	Throughout the study period: Day 0~450 or termination, whichever came first	Any serious adverse events occurring throughout the study period

Trial Locations

Locations (2)

National Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of