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

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

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

time.

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.

Regards, VergelPoWeRUSA.org