NCT01138215

Brief Summary

To study about the immunogenicity, safety and efficacy of varicella-zoster virus vaccine in HIV-infected children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

June 4, 2010

Last Update Submit

July 15, 2020

Conditions

HIV InfectionsVaricella-zoster Virus

Keywords

varicella-zoster virus vaccinevaricella-zoster virus antibodyimmunogenicitysafety and efficacyHIV-infected childrenAssess protective VZV AntibodyAdverse events from VZV vaccine

Outcome Measures

Primary Outcomes (1)

  • Proportion of children with protective VZV Antibody in HIV infected children after 2 doses of VZV vaccine.

    1 month after vaccine completion

Secondary Outcomes (2)

  • Adverse events from VZV vaccine.

    1 month after completion of vaccine

  • Compare proportion of children who developed VZV antibody by baseline characteristics e.g. immune status, age, gender.

    1 month after completion of vaccine

Study Arms (1)

1

EXPERIMENTAL

Receive 1 course of VZV vaccine : 2 doses of vaccines with 3 months apart.

Biological: VZV vaccination

Interventions

VZV vaccinationBIOLOGICAL

Dose : 0.5 ml Route : subcutaneous injection (SC)

1

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • HIV-infected children.
  • Aged between 1 to 15 years.
  • CD4 T lymphocyte percentage ≥ 15% or ≥ 200 cell/ml within 6 months at time of enrollment.
  • Written informed consent was obtained from each child's parent or guardian before enrollment.
  • HIV-infected children who age more than 7 years old sign assent.

You may not qualify if:

  • History of clinical varicella or zoster.
  • History of exposure to VZV within 1 month before study entry.
  • Received varicella vaccine.
  • Received immunoglobulin or blood product within 3 months before study entry.
  • Using oral steroid or immunosuppressive drugs within 3 months before study entry.
  • History of hypersensitivity to vaccine component (Neomycin).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsChickenpox

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus Infections

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 7, 2010

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

TH(1)