drugset / Trial / NCT02514018
Pilot Study to Describe Immune Responses of Healthy Women Following Immunization With Varicella Zoster Virus Vaccine
Phase 4
Unknown
45 enrolled
University of Toronto
Canadian Institutes of Health Research (CIHR) · collabKenyan AIDS Vaccine Initiative - Institute of Clinical Research (KAVI-ICR) · collabUniversity of Nairobi · collab
RandomizedParallel-groupOpen-label
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.
Timeline
- Start
- 2015-09
- Primary completion
- 2017-01
- Completion
- 2017-07
Outcome
Missed primary endpoint
paper VZV vaccination did not result in significant difference in the frequency of cervical activated (HLA-DR+CD38+) CD4+ T cells PMID 30511963 ↗
Publications
- Perciani CT, Farah B, Kaul R, Ostrowski MA, Mahmud SM, Anzala O, Jaoko W; KAVI-ICR Team; MacDonald KS. Live attenuated varicella-zoster virus vaccine does not induce HIV target cell activation. J Clin Invest. 2019 Feb 1;129(2):875-886. doi: 10.1172/JCI124473. Epub 2019 Jan 22.
- Perciani CT, Sekhon M, Hundal S, Farah B, Ostrowski MA, Anzala AO, McKinnon LR, Jaoko W, MacDonald KS; Institute of Tropical and Infectious Diseases (UNITID) Group and the Kenyan AIDS Vaccine Initiative-Institute of Clinical Research (KAVI-ICR) Team. Live Attenuated Zoster Vaccine Boosts Varicella Zoster Virus (VZV)-Specific Humoral Responses Systemically and at the Cervicovaginal Mucosa of Kenyan VZV-Seropositive Women. J Infect Dis. 2018 Sep 8;218(8):1210-1218. doi: 10.1093/infdis/jiy320.
- Perciani CT, Jaoko W, Walmsley S, Farah B, Mahmud SM, Ostrowski M, Anzala O, Team KI, MacDonald KS. 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. BMJ Open. 2017 Sep 21;7(9):e017391. doi: 10.1136/bmjopen-2017-017391.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VZVOka | Unknown | 19400 unknown | — |
Indications
No indication recorded.