Clinical trial NCT01245751: Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)
Official title: Safety, Tolerability and Immunogenicity of a Booster Dose of ZOSTAVAX™ Administered ≥10 Years After a First Dose Compared With a First Dose of ZOSTAVAX™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Varicella-zoster Vaccine
Keywords: Shingles
Vaccine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Colorado, Denver
name: Duke University
First posted: 2010-11-22
Enrollment: 600
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)
timeFrame: Day 1 (Baseline) and Week 6 postvaccination
measure: Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers
timeFrame: Day 1 (Baseline) and Week 6 postvaccination
Secondary outcomes:
measure: Number of Participants Reporting One or More Adverse Experiences
timeFrame: Up to 42 days postvaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Levin MJ, Schmader KE, Pang L, Williams-Diaz A, Zerbe G, Canniff J, Johnson MJ, Caldas Y, Cho A, Lang N, Su SC, Parrino J, Popmihajlov Z, Weinberg A. Cellular and Humoral Responses to a Second Dose of Herpes Zoster Vaccine Administered 10 Years After the First Dose Among Older Adults. J Infect Dis. 2016 Jan 1;213(1):14-22. doi: 10.1093/infdis/jiv480. Epub 2015 Oct 9.
citation: Weinberg A, Popmihajlov Z, Schmader KE, Johnson MJ, Caldas Y, Salazar AT, Canniff J, McCarson BJ, Martin J, Pang L, Levin MJ. Persistence of Varicella-Zoster Virus Cell-Mediated Immunity After the Administration of a Second Dose of Live Herpes Zoster Vaccine. J Infect Dis. 2019 Jan 7;219(2):335-338. doi: 10.1093/infdis/jiy514.