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

NCT ID: NCT01245751

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2015-05-31

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.

Conditions

Herpes Zoster; Varicella-zoster Vaccine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1: Booster Dose Participants ≥70 years of age

Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 NCT00007501)

Group Type: EXPERIMENTAL

Zoster Vaccine, Live

Intervention Type: BIOLOGICAL

Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study

Group 2: First Dose Participants ≥70 years of age

Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age

Group Type: EXPERIMENTAL

Zoster Vaccine, Live

Intervention Type: BIOLOGICAL

Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study

Group 3: First Dose Participants ≥60 and <70 years of age

Herpes zoster history-negative participants ≥60 and \<70 years of age who have never received Zoster Vaccine, Live

Group Type: EXPERIMENTAL

Zoster Vaccine, Live

Intervention Type: BIOLOGICAL

Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study

Group 4: First Dose Participants ≥50 and <60 years of age

Herpes zoster history-negative participants ≥50 and \<60 years of age who have never received Zoster Vaccine, Live

Group Type: EXPERIMENTAL

Zoster Vaccine, Live

Intervention Type: BIOLOGICAL

Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study

Interventions

Zoster Vaccine, Live

Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study

Intervention Type: BIOLOGICAL

Other Intervention Names

V211; ZOSTAVAX™

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 26452397 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30165651 (View on PubMed)

Other Identifiers

V211-029

Identifier Type: -

Identifier Source: org_study_id