SYNOPSIS
Study title
An observational pilot study to characterize the immune response
induced by the commercial Varicella Zoster Virus vaccine
Zostavax® (Merck) in healthy adult females in Nairobi, Kenya.
Clinical Phase IV
Trial Design Immediate vs delayed study
Study Population
HIV-1/2 negative, females at low risk of HIV aged 18-50 years of
age.
Planned Sample Size 44
Planned Trial Period 13 months after recruitment
Primary Outcome To measure cervical mucosal immune activation after VZVvaccination
in the context of VZV-effector responses.
Secondary Objective
To measure the effector VZV-specific CD8+ T cells at the rectal
mucosa after VZV vaccination;
To compare the immune activation observed in mucosal tissues
and in blood.
Primary Endpoint
The co-primary endpoints are the measurement of the percentage
of cervical CD38+CD4+T cells and the measurement of interleukin
6 (IL-6) and interleukin 1β (IL-1β) in vaginal secretion at 3
months after immunization with varicella vaccine when compared
to their own baseline. Changes in these parameters must be
significantly different from the changes observed in the same
period for the delayed group in order to be considered associated
to vaccination.
Secondary endpoints
An increase in the percentage of VZV-specific CD8+T cells at 3
months after immunization with varicella vaccine when compared
to their own baseline. This increase must be significantly different
from the change observed in the same period for the delayed group
in order to be considered associated to vaccination.
To compare the expression of co-receptors and activation markers
such as CCR5, α4β7, CD38, CD69 and HLA-DR in blood and
cervical CD4+T cells at 3 months after immunization with
varicella vaccine.
Investigational
Medicinal Product
Zostavax®
KAVI-VZV-001 Version 2.0 (01 September 2014) Page 9 of 49
Dose Zostavax® >19,400 PFU (Z)
Route Subcutaneous needle injection
Study Design
Vaccination Period
Group No. Wk 0 Wk 12
Immediate 22 Z -
Delayed 22 - Z
Follow-Up Duration
After the vaccination with Zostavax®, the delayed groups will be
followed-up for 9 months and the immediate groups for 12
months.
Trial Sponsor University of Toronto, Canada