Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly

Shingles Clinical Trial

Official title: Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly

Status Completed

Clinical Trial Summary

Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population.

In this trial, the investigators will study the immunologic differences of the FDA approved licensed shingles vaccine between a younger and an older group. Thirty three healthy volunteers between the ages of 25-40 and forty four healthy volunteers between the ages of 60-79 will be enrolled in the study. Each participant in the study will be given one shingles shot. Blood work will be obtained one month before vaccination, on the day of vaccination, one day, three days, seven days, fourteen days, one month, three months and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.

Clinical Trial Description

RATIONALE: Zoster vaccine is known to induce diminished antigen-specific T cell responses and lower protection in the elderly. Here we hypothesize that this is due to intrinsic defects in innate responses to the live attenuated virus, which translates into sub-optimal functional adaptive immune responses. Therefore, early innate signatures of vaccination should correlate with, and predict the immunogenicity of Zoster vaccine in the young and elderly.

STUDY DESIGN: Double center, open label study in which adult healthy volunteers will be vaccinated with Zoster vaccine. Blood samples will be collected on day D-30 (pre- vaccination) D0 (at vaccination) and D1, D3, D7, D14, D30, D90 and D180 (post vaccination) to study innate and adaptive immunity responses. Even though Zoster vaccine is considered safe, volunteers are asked to report and record any local or systemic AEs for 7 days post-vaccination. Also AEs will be reported for 30 days post-vaccination any SAE for 180 days post vaccination. AEs developing the day of the blood draw will also be reported ;

Related Conditions & MeSH terms

• Herpes Zoster
• Shingles

• NCT number: NCT01331161
• Study type: Interventional
• Source: Emory University
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Completion date: October 2012