immunogenicity and safety of recombinant zoster vaccine in people living with hiv

Conditions: Vaccination; Infection; Vaccine Adverse Reaction

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.

* 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.

Keywords: recombinant zoster vaccine vaccination of people living with hiv