NCT02514018

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Sep 2015

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

June 29, 2015

Last Update Submit

October 14, 2016

Conditions

Healthy

Keywords

Varicella-Zoster VirusImmune ActivationHIV VaccineMucosal Immunity

Outcome Measures

Primary Outcomes (1)

  • Change in the median frequency of cervical CD38+HLA-DR+CD4+T cells after VZV-vaccination as a measure of immune activation

    Comparison of the change in the median (Interquartile range - IQR) frequency of cervical CD38+HLA-DR+CD4+T cells between 1) Baseline and 3 months after (for the delayed group), and 2) Before and after 3 months of VZV vaccination (immediate and delayed groups).

    3 months after VZV-vaccination

Secondary Outcomes (10)

  • Composite measures of immune activation observed in mucosal tissues

    3 months after VZV-vaccination

  • Composite measures of mucosal homing marker and HIV co-receptors observed in mucosal tissues

    3 months after VZV-vaccination

  • Mucosal level of inflammation (including IL-1β, IL-6 and IL8)

    3 months after VZV-vaccination

  • Composite measures of immune activation observed in blood

    3 months after VZV-vaccination

  • Composite measures of mucosal homing marker and HIV co-receptors observed in blood

    3 months after VZV-vaccination

  • +5 more secondary outcomes

Other Outcomes (7)

  • Seroprevalence of Varicella-Zoster Virus (VZV)

    At Screening Phase (week 0)

  • Seroprevalence of Herpes Virus-2 (HSV-2)

    At Screening Phase (week 0)

  • Seroprevalence of Cytomegalovirus (CMV)

    At Screening Phase (week 0)

  • +4 more other outcomes

Study Arms (2)

Immediate Group

OTHER

Live-attenuated varicella-zoster virus vaccine (≥ 19,400 Plaque-forming unit - PFU) administered as a single-dose at day 0

Biological: Live-attenuated varicella-zoster virus vaccine

Delayed Group

OTHER

Live-attenuated varicella-zoster virus vaccine (≥ 19,400 PFU) administered as a single-dose at day 84 (+/- 3 days)

Biological: Live-attenuated varicella-zoster virus vaccine

Interventions

Live-attenuated varicella-zoster virus vaccineBIOLOGICAL

Commercial vaccine used to prevent shingles

Also known as: shingles vaccine, chickenpox vaccine, zoster vaccine, Zostavax® (Merck)
Delayed GroupImmediate Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy females, as assessed by a medical history, physical examination and laboratory tests;
  • Aged at least 18 years on the day of screening and no greater than 50 years on the day of the first vaccination.
  • VZV-seropositive, as assessed by the Vitek Immunodiagnostic Assay System (VIDAS) assay.
  • Ability to comply with the study requirements and available for follow-up for the planned duration of the study.
  • In the opinion of the Principal Investigator or designee, the volunteer has understood the information provided and signed the consent document.
  • Willing to undergo HIV testing, HIV counseling and to receive HIV test results three times during the study.
  • For women with potential to become pregnant, willing to use effective contraception or barrier methods, such as oral, patch, injectable, implant, ring contraceptives or intrauterine device to avoid pregnancy during the study (spermicide are not allowed).

You may not qualify if:

  • Any relevant abnormality on history or examination that, in the opinion of the Principal Investigator or designee, is clinically significant, and/or:
  • A high risk for HIV-acquisition defined by the experience of any of the follow situations:
  • Had unprotected vaginal or anal sex with a known HIV-1-infected person, a person known to be at high risk for HIV or a casual partner (i.e., no continuing, established relationship) within the previous 6 months;
  • Engaged in sex work for money or drugs within the previous 6 months;
  • Used injection drugs in the last 12 months;
  • Abuse of illicit or prescribed drugs, including alcohol;
  • Acquired one of the following sexually transmitted infection: chlamydia, gonorrhoea and syphilis in the last 12 months;
  • More than 1 sexual partner within the last 6 months;
  • New sexual partner within the last 3 months.
  • Persistent or recurrent bacterial vaginosis or vaginal candidiasis unresponsive to therapy (2 consecutive attempts by study team).
  • Confirmed HIV-1 or HIV-2 infection.
  • Any clinically significant acute or chronic medical condition that is considered progressive or, in the opinion of the Principal Investigator or designee, would make the volunteer unsuitable for the study (active or underlying diabetes, gastrointestinal, cardiovascular, malignancy, neurological, psychiatric, metabolic, renal, hepatic, respiratory, auto-immune diseases, psoriasis, primary and acquired immunodeficiency status and rectal problems).
  • Significant laboratory abnormalities, including coagulation (International Normalised Ratio- INR \<1.0 or \> 1.5).
  • A positive pregnancy test or breast-feeding at screening; for the participants with reproductive potential, unwilling to use an effective method of preventing pregnancy during the study.
  • Receipt of vaccine within the previous 2 months or planned receipt at any time until 6 months after vaccination with live-attenuated VZV vaccine.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KAVI-ICR, University of Nairobi

Nairobi, Kenya

Location

Related Publications (3)

  • 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.

    PMID: 30511963DERIVED

  • 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.

    PMID: 29800309DERIVED

  • 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.

    PMID: 28939581DERIVED

MeSH Terms

Conditions

Chickenpox

Interventions

Herpes Zoster VaccineChickenpox Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Herpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Walter Jaoko, MD

    KAVI-Institute of Clinical Research / University of Nairobi

    PRINCIPAL INVESTIGATOR

  • Kelly MacDonald, MD

    University of Toronto

    PRINCIPAL INVESTIGATOR

  • Omu Anzala, MD

    KAVI-Institute of Clinical Research / University of Nairobi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 29, 2015

First Posted

August 3, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

July 1, 2017

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

KE(1)