Clinical trial NCT00920218: Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A
Official title: Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Zoster
Keywords: Vaccine
Safety
Herpes Zoster
Immunogenicity
Stem cell transplantation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.

Detailed description: The Protocol Posting has been updated following Protocol amendment 2, Sep 2009. The sections impacted are: eligibility criteria.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
* Male and female subjects at least 18 years old at the time of vaccination;
* Serological evidence of prior VZV infection for all subjects born in 1980 or later and for subjects born outside the US before 1980 in a tropical or sub-tropical region. No testing for serological evidence of prior VZV infection is required for US subjects born before 1980;
* Has undergone autologous HCT within the past 50-70 days for treatment of Hodgkin lymphoma, non-Hodgkin lymphoma (T or B cell), myeloma or acute myeloid leukemia, and there are no plans for additional HCTs
* Written informed consent obtained from the subject;
* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
* Administration or planned administration of a vaccine that is not part of the study protocol since transplantation. However licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1;
* Administration of immunoglobulins since transplantation;
* Previous vaccination against varicella or HZ;
* History of HZ within the previous 12 months;
* Known exposure to VZV since transplantation;
* Evidence of active infection at the time of enrollment including a temperature of ≥ 37.5° C or any serious HCT-related complication;
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
* Hypersensitivity or intolerance to acyclovir or valacyclovir;
* Pregnant or lactating female.

Primary outcomes:
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day (Days 0-29) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Any time during the study up to Day 29 after the last vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Day 0 up to Month 15)
measure: Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders
timeFrame: Within the 30-day (Days 0-29) post last vaccination period
measure: Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders
timeFrame: During the entire study period (from Day 0 to Month 15)
measure: Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
timeFrame: At Month 0
measure: Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
timeFrame: At Month 1
measure: Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
timeFrame: At Month 2
measure: Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
timeFrame: At Month 3
measure: Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
timeFrame: At Month 4
measure: Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
timeFrame: At Month 4
measure: Anti-glycoprotein E (Anti-gE) Geometric Mean Antibody Concentrations
timeFrame: At Month 4
measure: Anti-gE Mean Antibody Concentrations
timeFrame: At Month 4
Secondary outcomes:
measure: Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens
timeFrame: At Months 0, 1, 2, 3, 4 and 15
measure: Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
timeFrame: At Months 0, 1, 2, 3 and 15
measure: Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations
timeFrame: At Months 0, 1, 2, 3, 4 and 15
measure: VZV-specific Mean Antibody Concentrations
timeFrame: At Months 0, 1, 2, 3, 4 and 15
measure: Anti-gE Geometric Mean Antibody Concentrations
timeFrame: At Months 0, 1, 2, 3 and 15
measure: Anti-gE Mean Antibody Concentrations
timeFrame: At Months 0, 1, 2, 3 and 15
measure: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
timeFrame: During the entire study period (from Day 0 to Month 15)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Duarte
country: United States
facility: GSK Investigational Site
state: California
city: Frisco
country: United States
facility: GSK Investigational Site
state: California
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Minnesota
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: GSK Investigational Site
state: Minnesota
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Stadtmauer EA, Sullivan KM, Marty FM, Dadwal SS, Papanicolaou GA, Shea TC, Mossad SB, Andreadis C, Young JA, Buadi FK, El Idrissi M, Heineman TC, Berkowitz EM. A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. Blood. 2014 Nov 6;124(19):2921-9. doi: 10.1182/blood-2014-04-573048. Epub 2014 Sep 18.