Clinical trial NCT00792623: Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).
Official title: A Phase III, Open-label, Multi-centre Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM), Given as a Primary Vaccination at 4.5 Months and 6.5 Months Post-transplantation, in Autologous Stem Cell/ Bone Marrow Transplant Recipients Aged 18 Years and Older.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Varicella
Keywords: Varicella
VarilrixTM
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-11-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.
* Ongoing requirement for antiviral therapy with anti-VZV activity beyond 4 months post-transplantation
* Patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation.
* Current drug and/or alcohol abuse.

Primary outcomes:
measure: Number of Subjects With a Varicella Vaccine Response
timeFrame: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
measure: Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers
timeFrame: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Secondary outcomes:
measure: Number of Subjects With a Varicella Vaccine Response
timeFrame: At 6.5 months post-transplantation = 2 months post first dose of vaccination
measure: Number of Seropositive Subjects for Anti-varicella Antibodies
timeFrame: 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)
measure: Anti-varicella Antibody Titers
timeFrame: 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)
measure: Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
timeFrame: During the 8-day (Days 0-7) post-vaccination period after each dose and across doses
measure: Number of Subjects With Any Fever
timeFrame: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
measure: Number of Subjects With Any and Related Rash
timeFrame: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the active phase of the study (up to Month 24)
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.