Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Herpes Zoster

Treatments: Biological: Placebo vaccine (saline); Biological: Herpes Zoster Vaccine 1437173A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00920218

110258

Details and patient eligibility

About

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.

Full description

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

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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121 participants in 4 patient groups, including a placebo group

GSK 1437173A F1 Group

Experimental group

Description:

Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Treatment:

Biological: Herpes Zoster Vaccine 1437173A

GSK 1437173A F2 Group

Experimental group

Description:

Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Treatment:

Biological: Herpes Zoster Vaccine 1437173A

Placebo-GSK 1437173A F1 Group

Experimental group

Description:

Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Treatment:

Biological: Herpes Zoster Vaccine 1437173A

Biological: Placebo vaccine (saline)

Placebo Group

Placebo Comparator group

Description:

Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Treatment:

Biological: Placebo vaccine (saline)