Is It Safe to Give the Shingles Vaccine to HIV Positive People?

CROI 1012: Oral presentation  #96 . ZOSTAVAX Is Generally Safe and
Immunogenic in HIV+ Adults Virologically Suppressed on ART: Results of a Phase
2, Randomized, Double-blind, Placebo-controlled Trial
Risk of
recurrent/severe herpes zoster (HZ) is increased in HIV+ patients.   To date, use of ZOSTAVAX® (ZV; live
attenuated zoster vaccine live) has been contraindicated for people with HIV
due to safety concerns, although some physicians have been prescribing it for
HIV+ patients with high CD4 cells.  For
those with lower CD4 cells, the standard oral herpes drugs have been commonly
used for herpes outbreaks or as prophylaxis to prevent further outbreaks. This
vaccine  has generally been shown to be safe
and effective in reducing HZ incidence/severity in HIV negative adults ≥50 years
old, but it has not been evaluated in HIV+ adults.
This ACTG study was a randomized
, double-blind, placebo-controlled  to
assess safety and immunogenicity of 2 doses of ZV in HIV+ adults ≥18 years old
(CD4 >200 copies/µL; HIV RNA <75 copies/mL for ≥6 months on stable ART;
varicella-zoster virus (VZV) seropositive, history of VZV or HZ >1 year
prior to entry). Patients were stratified by screening CD4 (>350 copies/µL
[High CD4] vs ≥200 to 349 copies/µL [Low CD4]), received ZV or placebo on day 0
and week 6; and were evaluated at weeks 2, 6, 8, 12, and 24.
The study enrolled 395
patients:  203 High CD4 patients (152
ZV/51 placebo) and 192 Low CD4 patients (144 ZV/48 placebo); 3 (1 ZV, 2
placebo) received no vaccine and were excluded. Patients were 84% male; 66%
white, 31% black, 22% Hispanic; median age 49 years; median High CD4= 602
cells/mL, Low CD4 =283 cells/mL. Of 295 ZV patients, 15 experienced primary
safety endpoints, none vaccine related. In the first 48 patients, median
baseline natural log ZV antibody titer was 5.60 and was higher at week 12 for
ZV  vs placebo .  Geometric mean fold-rise was 1.75 ZV vs 1.09
placebo. Week 12 VZV antibody titer (after 2 ZV doses) was similar to week 6 (1
dose). High CD4 patients had higher antibody titer than Low CD4 patients over
The presentation did
not include data on the vaccine’s effects on patients’ HIV viral load and CD4
cells. The study team will present CD4 and HIV viral load data in the
future.  Patients will not be followed
beyond 24 weeks to see if the incidence of shingles does in fact decrease as
much as it does in HIV negative people.

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