Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2018 03 26() doi 10.1093/cid/ciy242
Herpes zoster (HZ) risk is increased in HIV-infected persons. Live attenuated zoster vaccine (ZV) reduces HZ incidence and severity in older adults; ZV safety and immunogenicity data in HIV-infected adults are limited.
We conducted a randomized, double-blind, placebo-controlled trial in HIV-infected adults virologically suppressed on antiretroviral therapy (ART). Participants, stratified by CD4+ (200-349 or ≥350 cells/µL), were randomized 3:1 to receive ZV or placebo on day 0 and week 6. The primary composite endpoint was serious adverse event or Grade 3/4 signs/symptoms within 6 weeks after each dose. Immunogenicity (varicella zoster virus (VZV)-specific gpELISA and interferon-gamma ELISPOT responses) was assessed at 6 and 12 weeks post-vaccination.
Of 395 participants (296 ZV vs. 99 placebo) 84% were male, 47% white, 29% black, 22% Hispanic; median age 49. Safety endpoints occurred in 15 ZV and 2 placebo recipients (5.1% [95% CI 2.9, 8.2] vs. 2.1% [95% CI 0.3, 7.3]; P=0.26). Injection site reactions occurred in 42% ZV [95% CI 36.3, 47.9] vs. 12.4% placebo recipients [95% CI 6.6, 20.6]; P<0.001). Week 12 median (IQR) natural log VZV antibody (Ab) titer was higher for ZV (6.30 [5.64, 6.96)]) vs. placebo (5.48 [4.63, 6.44]; p<0.001) overall and in the high CD4+ stratum (P=0.003). VZV Ab titers were similar after one or two ZV doses. PCR-confirmed HZ occurred in 2 participants (1 ZV; 1 placebo); none were vaccine-strain related. Conclusions
Two doses of ZV in HIV-infected adults suppressed on ART with CD4+ counts ≥200 cells/µL were generally safe and immunogenic.
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