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

Vaccine Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05898464
• Other study ID #: 2304-110-1426
• Status: Recruiting
• Phase: Phase 4
• Start date: June 27, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: February 2024
• Source: Seoul National University Hospital
• Contact: Wan Beom Park, M.D., PhD.
• Phone: 82-2-2072-3596
• Email: wbpark1[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Zoster
• Vaccination; Infection
• Vaccine Adverse Reaction

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	National Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Medical Center, Seoul, SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (12)

Berkowitz EM, Moyle G, Stellbrink HJ, Schurmann D, Kegg S, Stoll M, El Idrissi M, Oostvogels L, Heineman TC; Zoster-015 HZ/su Study Group. Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study. J Infect Dis. 2015 Apr 15;211(8):1279-87. doi: 10.1093/infdis/jiu606. Epub 2014 Nov 3. — View Citation

Buchbinder SP, Katz MH, Hessol NA, Liu JY, O'Malley PM, Underwood R, Holmberg SD. Herpes zoster and human immunodeficiency virus infection. J Infect Dis. 1992 Nov;166(5):1153-6. doi: 10.1093/infdis/166.5.1153. — View Citation

Centers for Disease Control and Prevention (CDC). Revised surveillance case definition for HIV infection--United States, 2014. MMWR Recomm Rep. 2014 Apr 11;63(RR-03):1-10. — View Citation

Domingo P, Torres OH, Ris J, Vazquez G. Herpes zoster as an immune reconstitution disease after initiation of combination antiretroviral therapy in patients with human immunodeficiency virus type-1 infection. Am J Med. 2001 Jun 1;110(8):605-9. doi: 10.1016/s0002-9343(01)00703-3. — View Citation

Erdmann NB, Prentice HA, Bansal A, Wiener HW, Burkholder G, Shrestha S, Tang J. Herpes Zoster in Persons Living with HIV-1 Infection: Viremia and Immunological Defects Are Strong Risk Factors in the Era of Combination Antiretroviral Therapy. Front Public Health. 2018 Mar 12;6:70. doi: 10.3389/fpubh.2018.00070. eCollection 2018. — View Citation

Gebo KA, Kalyani R, Moore RD, Polydefkis MJ. The incidence of, risk factors for, and sequelae of herpes zoster among HIV patients in the highly active antiretroviral therapy era. J Acquir Immune Defic Syndr. 2005 Oct 1;40(2):169-74. doi: 10.1097/01.qai.0000178408.62675.b0. — View Citation

Grabar S, Tattevin P, Selinger-Leneman H, de La Blanchardiere A, de Truchis P, Rabaud C, Rey D, Daneluzzi V, Ferret S, Lascaux AS, Hanslik T, Costagliola D, Launay O; French Hospital Database on HIV (FHDH-ANRS CO4 Cohort). Incidence of herpes zoster in HIV-infected adults in the combined antiretroviral therapy era: results from the FHDH-ANRS CO4 cohort. Clin Infect Dis. 2015 Apr 15;60(8):1269-77. doi: 10.1093/cid/ciu1161. Epub 2015 Jan 18. — View Citation

Harbecke R, Cohen JI, Oxman MN. Herpes Zoster Vaccines. J Infect Dis. 2021 Sep 30;224(12 Suppl 2):S429-S442. doi: 10.1093/infdis/jiab387. — View Citation

Kim YJ, Woo JH, Kim MJ, Park DW, Song JY, Kim SW, Choi JY, Kim JM, Han SH, Lee JS, Choi BY, Lee JS, Kim SS, Kee MK, Kang MW, Kim SI. Opportunistic diseases among HIV-infected patients: a multicenter-nationwide Korean HIV/AIDS cohort study, 2006 to 2013. Korean J Intern Med. 2016 Sep;31(5):953-60. doi: 10.3904/kjim.2014.322. Epub 2016 Apr 27. — View Citation

Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. National Institutes of Health, Centers for Disease Control and Prevention, HIV Medicine Association, and Infectious Diseases Society of America. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-andadolescent-opportunistic-infection. Accessed March 31, 2023

Song JY, Lee JS, Jung HW, Choi HJ, Lee JS, Eom JS, Cheong HJ, Jung MH, Kim WJ. Herpes zoster among HIV-infected patients in the highly active antiretroviral therapy era: Korean HIV cohort study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):417-8. doi: 10.1097/QAI.0b013e3181b1d6dc. No abstract available. — View Citation

Thompson MA, Horberg MA, Agwu AL, Colasanti JA, Jain MK, Short WR, Singh T, Aberg JA. Primary Care Guidance for Persons With Human Immunodeficiency Virus: 2020 Update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2021 Dec 6;73(11):e3572-e3605. doi: 10.1093/cid/ciaa1391. Erratum In: Clin Infect Dis. 2021 Dec 08;: Clin Infect Dis. 2022 Nov 30;75(11):2052. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month, 13 months after 2nd dose
Secondary	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.	1 month, 13 months after 2nd dose
Secondary	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	1 month, 13 months after 2nd dose
Secondary	Grade 3/4 adverse events (AE)	Solicited and unsolicited local and systemic adverse events occurring within 7 days after the first and second dose	Within 7 days (Day 0-6) after the first and second dose.
Secondary	Any serious adverse events (SAEs)	Any serious adverse events occurring throughout the study period	Throughout the study period: Day 0~450 or termination, whichever came first
Secondary	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	1 month after 2nd dose
Secondary	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);	Within 3 months after 2nd dose