Clinical trial NCT05898464: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Vaccination; Infection
Vaccine Adverse Reaction
Keywords: Recombinant zoster vaccine
Vaccination of people living with HIV
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Medical Center, Seoul
name: SMG-SNU Boramae Medical Center
First posted: 2023-06-12
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria (for HIV #1, HIV #2) :

* 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.

Inclusion Criteria (for non-HIV) :

* 50 years old or older who have voluntarily agreed to participate in the study.
* Do not have uncontrolled chronic medical conditions

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.

Primary outcomes:
measure: Humoral immune response
timeFrame: 1 month, 13 months after 2nd dose
Secondary outcomes:
measure: Cell-mediated immunogenicity
timeFrame: 1 month, 13 months after 2nd dose
measure: Differences in humoral immune response and cell mediated immunogenecity
timeFrame: 1 month, 13 months after 2nd dose
measure: Grade 3/4 adverse events (AE)
timeFrame: Within 7 days (Day 0-6) after the first and second dose.
measure: Any serious adverse events (SAEs)
timeFrame: Throughout the study period: Day 0~450 or termination, whichever came first
measure: Increase in HIV Viral Load or decrease in CD4+ T-cell Count
timeFrame: 1 month after 2nd dose
measure: Any AIDS-defining disease
timeFrame: Within 3 months after 2nd dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: National Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Wan Beom Park, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
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