Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-02-20 @ 10:12 AM
Study NCT ID:
NCT02514018
Status:
UNKNOWN
Last Update Posted:
2016-10-17
First Post:
2015-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Describe Immune Responses of Healthy Women Following Immunization With Varicella Zoster Virus Vaccine
Sponsor:
University of Toronto
Organization:
Study Overview
Official Title:
A Pilot Study to Characterize the Immune Response Induced by a Commercial Varicella Zoster Virus Vaccine in Healthy Adult Females in Nairobi, Kenya.
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KAVI-VZV-001
Brief Summary:
The re-activating nature of Varicella Zoster Virus (VZV) may allow life long boosting when used as a vaccine vector in conjunction with HIV to generate durable immunity systemically and at the mucosa. This study aims to characterize mucosal immunity before and after vaccination with a commercial live-attenuated varicella-zoster virus vaccine with respect to immune activation state, mucosal homing properties and VZV-specific effector immune responses in healthy women at low risk for HIV acquisition.
Detailed Description:
An ideal HIV vaccine should be able to induce an effector specific immune response at the mucosal site which serves as the portal of HIV entry. The use of a persistent replicating viral vector such as Varicella-Zoster Virus (VZV) has great potential to assemble this specific response. Live-attenuated varicella-zoster virus has been used as a vaccine worldwide for over 25 years and has a well-described safety profile. However, its immunogenicity data in the African population are lacking.
The general objective of this study will be to measure the magnitude and kinetics of the effector immune response and immune activation induced by live-attenuated varicella-zoster virus vaccine in a population of Kenyan women. Specifically, the study will measure immune activation in both cervical and rectal mucosae in the context of VZV-effector responses after vaccination and compare the observed immune activation in mucosal tissues and in blood.
A total of 44 healthy women in Nairobi, aged 18-50 years will be recruited into the study, after obtaining their written informed consent. Eligibility to participate in the study will depend on results of laboratory tests, review of medical history, physical examination and answers to questions about HIV risk behaviours.
The study will assess immune responses to both immediate and delayed administration of live-attenuated virus varicella-zoster vaccine in VZV-seropositive individuals. Participants will be randomly divided into 2 groups. Group 1 will receive a single dose of the vaccine at day 0 and Group 2 at day 84. The participants will be followed for a period of 9-12 months after receiving the vaccine.
The general objective of this study will be to measure the magnitude and kinetics of the effector immune response and immune activation induced by live-attenuated varicella-zoster virus vaccine in a population of Kenyan women. Specifically, the study will measure immune activation in both cervical and rectal mucosae in the context of VZV-effector responses after vaccination and compare the observed immune activation in mucosal tissues and in blood.
A total of 44 healthy women in Nairobi, aged 18-50 years will be recruited into the study, after obtaining their written informed consent. Eligibility to participate in the study will depend on results of laboratory tests, review of medical history, physical examination and answers to questions about HIV risk behaviours.
The study will assess immune responses to both immediate and delayed administration of live-attenuated virus varicella-zoster vaccine in VZV-seropositive individuals. Participants will be randomly divided into 2 groups. Group 1 will receive a single dose of the vaccine at day 0 and Group 2 at day 84. The participants will be followed for a period of 9-12 months after receiving the vaccine.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: