Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)

Shingles Clinical Trial

Official title:

A Double-Blind, Placebo-Controled, Randomized Study to Evaluate Safety, Tolerability, and Immunogenicity After 1 and 2 Doses of Zoster Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109122
• Other study ID #: V211-007
• Secondary ID: 2005_017
• Status: Completed
• Phase: Phase 2
• First received: April 22, 2005
• Last updated: March 14, 2017
• Start date: November 2001
• Est. completion date: July 2006

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).

Description:

The duration of treatment is 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2006
• Est. primary completion date: February 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Individuals who are at least 60 years of age with a history of varicella (shingles)

• Females must have been postmenopausal.

Exclusion Criteria:

• Subjects who did not previously participate in the main study of this protocol.

• Subject had shingles since their 6 month follow-up visit in main phase of study.

Related Conditions & MeSH terms

• Herpes Zoster
• Shingles

Intervention

Biological:
• zoster vaccine live (Oka/Merck)

• Comparator: placebo (unspecified)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Vermeulen JN, Lange JM, Tyring SK, Peters PH, Nunez M, Poland G, Levin MJ, Freeman C, Chalikonda I, Li J, Smith JG, Caulfield MJ, Stek JE, Chan IS, Vessey R, Schödel FP, Annunziato PW, Schlienger K, Silber JL. Safety, tolerability, and immunogenicity afte — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VZV ELISPOT response ~6 weeks after 1 and 2 doses		6 weeks after 1 and 2 doses
Secondary	To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo		1 through 3 years after vaccination