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

Merck Sharp & Dohme LLC180 enrolled

Overview

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).

The duration of treatment is 12 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

180

Conditions

Shingles

Interventions

zoster vaccine live (Oka/Merck)BIOLOGICAL

Comparator: placebo (unspecified)BIOLOGICAL

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

VZV ELISPOT response ~6 weeks after 1 and 2 doses

Time frame: 6 weeks after 1 and 2 doses

Secondary Outcomes

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

Time frame: 1 through 3 years after vaccination

Data from ClinicalTrials.gov

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