Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)

Safety, Tolerability and Immunogenicity of a Booster Dose of ZOSTAVAX™ Administered ≥10 Years After a First Dose Compared With a First Dose of ZOSTAVAX™

This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who received their first dose of Zoster Vaccine, Live. The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus (VZV) antibodies.

All participants were followed for one year after completion of the 42-day post-vaccination period while Groups 1 and 2 were followed for a total of three years.

Inclusion Criteria:

• All Groups:

  • Must not have a fever of ≥100.4° F on the day of vaccination
  • Any underlying chronic illness must be in stable condition
  • History of varicella or residence in a VZV-endemic area for ≥30 years

• Group 1:

  • 70 years of age or older
  • Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study

• Group 2:

  • 70 years of age or older

• Group 3:

  • 60 to 69 years of age

• Group 4:

  • 50 to 59 years of age

Exclusion Criteria:

• All Groups:

  • History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin
  • Prior history of herpes zoster
  • Pregnant or breast-feeding, or expecting to conceive within the duration of the study
  • Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination
  • Received any other vaccine within 4 weeks prevaccination
  • On immunosuppressive therapy
  • Has known or suspected immune dysfunction
  • Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir.

• Groups 2, 3, and 4:

  • Has previously received any varicella or zoster vaccine