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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Varicella-zoster Vaccine

Herpes Zoster

Treatments

Biological: Zoster Vaccine, Live

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01245751

V211-029

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

600 participants in 4 patient groups

Group 1: Booster Dose Participants ≥70 years of age

Experimental group

Description:

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)

Treatment:

Biological: Zoster Vaccine, Live

Group 2: First Dose Participants ≥70 years of age

Experimental group

Description:

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

Treatment:

Biological: Zoster Vaccine, Live

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

Experimental group

Description:

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

Treatment:

Biological: Zoster Vaccine, Live

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

Experimental group

Description:

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