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

NCT ID: NCT00920218

Last Updated: 2017-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-14

Study Completion Date

2012-03-21

Brief Summary

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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

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

Conditions

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Herpes Zoster

Keywords

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Vaccine Safety Herpes Zoster Immunogenicity Stem cell transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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GSK 1437173A F1 Group

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.

Group Type EXPERIMENTAL

Herpes Zoster Vaccine 1437173A

Intervention Type BIOLOGICAL

Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.

GSK 1437173A F2 Group

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.

Group Type EXPERIMENTAL

Herpes Zoster Vaccine 1437173A

Intervention Type BIOLOGICAL

Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.

Placebo-GSK 1437173A F1 Group

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.

Group Type EXPERIMENTAL

Herpes Zoster Vaccine 1437173A

Intervention Type BIOLOGICAL

Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.

Placebo vaccine (saline)

Intervention Type BIOLOGICAL

1 or 3 doses of Placebo (saline) injected intramuscularly.

Placebo Group

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.

Group Type PLACEBO_COMPARATOR

Placebo vaccine (saline)

Intervention Type BIOLOGICAL

1 or 3 doses of Placebo (saline) injected intramuscularly.

Interventions

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Herpes Zoster Vaccine 1437173A

Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.

Intervention Type BIOLOGICAL

Placebo vaccine (saline)

1 or 3 doses of Placebo (saline) injected intramuscularly.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

Duarte, California, United States

Site Status

GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

Boston, Massachusetts, United States

Site Status

GSK Investigational Site

Minneota, Minnesota, United States

Site Status

GSK Investigational Site

Rochester, Minnesota, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Chapel Hill, North Carolina, United States

Site Status

GSK Investigational Site

Durham, North Carolina, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25237196 (View on PubMed)

Other Identifiers

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110258

Identifier Type: -

Identifier Source: org_study_id