NCT02514018

Pilot Study to Describe Immune Responses of Healthy Women Following Immunization With Varicella Zoster Virus Vaccine

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Live-attenuated varicella-zoster virus vaccine	Commercial vaccine used to prevent shingles

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-01-01
• Completion: 2017-07-01
• First posted: 2015-08-03
• Last updated: 2016-10-17

Locations

1 site across 1 country: Kenya