Safety and Immunogenicity of an Adjuvanted Herpes Zoster Subunit Candidate Vaccine in HIV-Infected Adults: A Phase 1/2a Randomized, Placebo-Controlled Study

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Abstract

Background. Human 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.

Methods. This 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/mm3, 14 ART recipients with a CD4+ T-cell count of 50–199 cells/mm3, and 15 ART-naive adults with a CD4+ T-cell count of ≥500 cells/mm3. 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.

Results. One 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.

Conclusions. HZ/su was immunogenic and had a clinically acceptable safety profile in HIV-infected adults.

Clinical Trials Registration. NCT01165203.

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