• Elchonon M Berkowitz, Graeme Moyle, Hans-Jürgen Stellbrink, Dirk Schürmann, Stephen Kegg, Matthias Stoll, Mohamed El Idrissi, Lidia Oostvogels, Thomas C Heineman, and Zoster-015 HZ/su Study Group.
• GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
• J. Infect. Dis. 2015 Apr 15;211(8):1279-87.

BackgroundHuman immunodeficiency virus (HIV)-infected individuals are at increased risk of herpes zoster (HZ), even in the antiretroviral therapy (ART) era. Because concerns exist about the use of live-attenuated vaccines in immunocompromised individuals, a subunit vaccine may be an appropriate alternative.MethodsThis phase 1/2, randomized, placebo-controlled study evaluated the immunogenicity and safety of an investigational HZ subunit vaccine (HZ/su). Three cohorts of HIV-infected adults aged ≥18 years were enrolled: 94 ART recipients with a CD4(+) T-cell count of ≥200 cells/mm(3), 14 ART recipients with a CD4(+) T-cell count of 50-199 cells/mm(3), and 15 ART-naive adults with a CD4(+) T-cell count of ≥500 cells/mm(3). Subjects received 3 doses of HZ/su (50 µg varicella-zoster virus glycoprotein E [gE] combined with AS01B adjuvant) or 3 doses of saline at months 0, 2, and 6.ResultsOne month after dose 3, serum anti-gE antibody concentrations and frequencies of gE-specific CD4(+) T cells were higher following HZ/su vaccination than after receipt of saline (P < .0001). Median cell-mediated immune responses peaked after dose 2. Humoral and cell-mediated immune responses persisted until the end of the study (month 18). No vaccination-related serious adverse events were reported. No sustained impact on HIV load or CD4(+) T-cell count was noted following vaccinations.ConclusionsHZ/su was immunogenic and had a clinically acceptable safety profile in HIV-infected adults.Clinical Trials RegistrationNCT01165203.© The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.

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