Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).

NCT00792623 | Completed Phase 2 Results

• 1 other identifier: 208133/178
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to assess the immunogenicity and safety of varicella vaccination in a population of autologous peripheral stem cell/ bone marrow transplantation recipients who have reached at least four months post-transplantation.

Conditions

Varicella

Keywords

Varicella; VarilrixTM

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With a Varicella Vaccine Response

  Vaccine response was defined as: for initially seropositive subjects, an antibody titer at Month 8 post-transplantation above or equal to (≥) 4 fold the pre-vaccination antibody titer.

  At 8 months post-transplantation = 1.5 months post-second dose of vaccination

• Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers

  Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).

  At 8 months post-transplantation = 1.5 months post-second dose of vaccination

Secondary Outcomes (8)

• Number of Subjects With a Varicella Vaccine Response

  At 6.5 months post-transplantation = 2 months post first dose of vaccination

• Number of Seropositive Subjects for Anti-varicella Antibodies

  At pre-transplantation (Month 0), pre-vaccination visit (at 4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 months post-second dose of vaccination)

• Anti-varicella Antibody Titers

  At pre-transplantation (Month 0), pre-vaccination visit (4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 post-second dose of vaccination)

• Number of Subjects With Any and Grade 3 Solicited Local Adverse Events

  During the 8-day (Days 0-7) post-vaccination period after each dose and across doses

• Number of Subjects With Any Fever

  During the 43-day (Days 0-42) post-vaccination period after each dose and across doses

Study Arms (1)

Varilrix Group

EXPERIMENTAL

Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.

Biological: VarilrixTM

Interventions

VarilrixTM BIOLOGICAL

Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.

Varilrix Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening phase:
• A male or female ≥ 18 years of age at the time of study entry.
• Written informed consent obtained from the subject prior to study entry.
• Patients who are planned to undergo autologous peripheral stem cell/ bone marrow transplantation.
• Subjects who the investigator believes can and will comply with the requirements of the protocol
• If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation.
• Active phase:
• Patients who are confirmed to have undergone autologous peripheral stem cell/ bone marrow transplantation.
• If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation.

You may not qualify if:

• Screening phase:
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation.
• History of allergy to any component of the vaccine.
• Patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation.
• Current drug and/or alcohol abuse.
• Active phase:
• Use of any investigational or non-registered product (drug or vaccine) during the active phase of the study period.
• Use of immunosuppressants or other immune-modifying drugs within 14 days preceding the administration of the first dose of the study vaccine or planned use during the active phase of the study period.
• Use of rituximab (MabThera) more than 60 days after transplant.
• Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation.
• History of allergy to any component of the vaccine
• Patients with VZV disease after transplantation and prior to vaccination.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

GSK Investigational Site

Melbourne, Victoria, 3004, Australia

Location

GSK Investigational Site

Melbourne, Victoria, 3050, Australia

Location

Related Publications (1)

• Sasadeusz J, Prince HM, Schwarer A, Szer J, Stork A, Bock HL, Povey M, Nicholson O, Innis BL. Immunogenicity and safety of a two-dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation. Transpl Infect Dis. 2014 Dec;16(6):1024-31. doi: 10.1111/tid.12295. Epub 2014 Oct 1.

  PMID: 25272081 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 18, 2008
• Study Start: September 8, 2003
• Primary Completion: September 10, 2007
• Study Completion: September 10, 2007
• Last Updated: November 8, 2018
• Results First Posted: July 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (3)