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

Herpes Zoster Clinical Trial

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™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245751
• Other study ID #: V211-029
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2010
• Last updated: January 25, 2016
• Start date: April 2011
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information will be compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who are receiving their first dose of Zoster Vaccine, Live. The study will 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.

Description:

After completion of the 42-day postvaccination period, participants in Groups 3 and 4 will have 1 year postvaccination follow-up and participants in Groups 1 and 2 will have 3 years postvaccination follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 2015
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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) (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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Duke University, University of Colorado, Denver

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)	VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)	Week 6 postvaccination	No
Primary	Geometric Mean Fold Rise (GMFR) From Day 1 to Week 6 Postvaccination in VZV Antibody Titers	VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.	Day 1 and Week 6 postvaccination	No
Secondary	Number of Participants Reporting One or More Adverse Experiences	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.; A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention.	Up to 42 days postvaccination	Yes