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Safety and Immunogenicity of Zoster Vaccine Live in HIV-Infected Adults with CD4+ Cell Counts Above 200 Cells/mL Virologically Suppressed on Antiretroviral Therapy.

Safety and Immunogenicity of Zoster Vaccine Live in HIV-Infected Adults with CD4+ Cell Counts Above 200 Cells/mL Virologically Suppressed on Antiretroviral Therapy.
Author Information (click to view)

Benson CA, Andersen JW, Macatangay BJC, Mailliard RB, Rinaldo CR, Read S, Bozzolo DR, Purdue L, Jennings C, Keefer MC, Glesby M, Tebas P, Russell AF, Martin J, Annunziato P, Popmihajlov Z, Lennox JL,


Benson CA, Andersen JW, Macatangay BJC, Mailliard RB, Rinaldo CR, Read S, Bozzolo DR, Purdue L, Jennings C, Keefer MC, Glesby M, Tebas P, Russell AF, Martin J, Annunziato P, Popmihajlov Z, Lennox JL, (click to view)

Benson CA, Andersen JW, Macatangay BJC, Mailliard RB, Rinaldo CR, Read S, Bozzolo DR, Purdue L, Jennings C, Keefer MC, Glesby M, Tebas P, Russell AF, Martin J, Annunziato P, Popmihajlov Z, Lennox JL,

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Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2018 03 26() doi 10.1093/cid/ciy242

Abstract
Background
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.

Methods
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.

Results
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.

Clinical Trials Registration
NCT00851786.

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