Advertisement

 

 

Protocol of a randomised controlled trial characterising the immune responses induced by varicella-zoster virus (VZV) vaccination in healthy Kenyan women: setting the stage for a potential VZV-based HIV vaccine.

Protocol of a randomised controlled trial characterising the immune responses induced by varicella-zoster virus (VZV) vaccination in healthy Kenyan women: setting the stage for a potential VZV-based HIV vaccine.
Author Information (click to view)

Perciani CT, Jaoko W, Walmsley S, Farah B, Mahmud SM, Ostrowski M, Anzala O, Team KI, MacDonald KS,


Perciani CT, Jaoko W, Walmsley S, Farah B, Mahmud SM, Ostrowski M, Anzala O, Team KI, MacDonald KS, (click to view)

Perciani CT, Jaoko W, Walmsley S, Farah B, Mahmud SM, Ostrowski M, Anzala O, Team KI, MacDonald KS,

Advertisement
Share on FacebookTweet about this on TwitterShare on LinkedIn

BMJ open 2017 09 217(9) e017391 doi 10.1136/bmjopen-2017-017391

Abstract
INTRODUCTION
A protective HIV vaccine would be expected to induce durable effector immune responses at the mucosa, restricting HIV infection at its portal of entry. We hypothesise that use of varicella-zoster virus (VZV) as an HIV delivery vector could generate sustained and robust tissue-based immunity against HIV antigens to provide long-term protection against HIV. Given that HIV uniquely targets immune-activated T cells, the development of human vaccines against HIV must also involve a specific examination of the safety of the vector. Thus, we aim to evaluate the effects of VZV vaccination on the recipients’ immune activation state, and on VZV-specific circulating humoral and cellular responses in addition to those at the cervical and rectal mucosa.

METHODS AND ANALYSIS
This open-label, randomised, longitudinal crossover study includes healthy Kenyan VZV-seropositive women at low risk for HIV infection. Participants receive a single dose of a commercial live-attenuated VZVOka vaccine at either week 0 (n=22) or at week 12 (n=22) of the study and are followed for 48 and 36 weeks postvaccination, respectively. The primary outcome is the change on cervical CD4(+) T-cell immune activation measured by the coexpression of CD38 and HLA-DR 12 weeks postvaccination compared with the baseline (prevaccination). Secondary analyses include postvaccination changes in VZV-specific mucosal and systemic humoral and cellular immune responses, changes in cytokine and chemokine measures, study acceptability and feasibility of mucosal sampling and a longitudinal assessment of the bacterial community composition of the mucosa.

ETHICS AND DISSEMINATION
The study has ethical approval from Kenyatta National Hospital/University of Nairobi Ethics and Research Committee, the University of Toronto Research Ethics Board and by Kenyan Pharmacy and Poisons Board. Results will be presented at conferences, disseminated to participants and stakeholders as well as published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER
NCT02514018. Pre-results.

Submit a Comment

Your email address will not be published. Required fields are marked *

twenty + 7 =

[ HIDE/SHOW ]