Herpes ZosterPhase 2NCT00920218

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

A Phase 2 study testing Herpes Zoster Vaccine 1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Herpes Zoster
What is being tested?: Herpes Zoster Vaccine 1437173A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: 11 sitesUnited States
Study dates: 14 Jul 2009to 21 Mar 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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 locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Chapel Hill, North Carolina, 27599
GSK Investigational Site
Cleveland, Ohio, 44195
GSK Investigational Site
Duarte, California, 91010
GSK Investigational Site
Durham, North Carolina, 27705
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Minneota, Minnesota, 55455
GSK Investigational Site
New York, New York, 10065
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
San Francisco, California, 94143

Other trials in United States

About this study

Official title: Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A

Read the detailed description

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

Conditions: Herpes Zoster
Being tested: Herpes Zoster Vaccine 1437173A, Placebo vaccine (saline)
Keywords: Vaccine, Safety, Herpes Zoster, Immunogenicity, Stem cell transplantation
Medical subject headings: Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Herpes Zoster Vaccine 1437173ABiological
Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.
Placebo vaccine (saline)Biological
1 or 3 doses of Placebo (saline) injected intramuscularly.

Study groups in NCT00920218
Study group	Role	What they receive
GSK 1437173A F1 Group	Experimental	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. Receives: Biological: Herpes Zoster Vaccine 1437173A
GSK 1437173A F2 Group	Experimental	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. Receives: Biological: Herpes Zoster Vaccine 1437173A
Placebo-GSK 1437173A F1 Group	Experimental	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. Receives: Biological: Herpes Zoster Vaccine 1437173A; Biological: Placebo vaccine (saline)
Placebo Group	Placebo comparator	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. Receives: Biological: Placebo vaccine (saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms [including nausea, vomiting, diarrhoea and abdominal pain], temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities.
Measured: During the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Any time during the study up to Day 29 after the last vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (from Day 0 up to Month 15)
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders
Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Measured: Within the 30-day (Days 0-29) post last vaccination period
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders
Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Measured: During the entire study period (from Day 0 to Month 15)
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Measured: At Month 0
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Measured: At Month 1
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Measured: At Month 2
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Measured: At Month 3
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Measured: At Month 4
Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma [IFN-γ], Interleukin 2 [IL-2], Tumour Necrosis Factor alpha [TNF-α] and/or CD40 Ligand [CD40L] as determined by in vitro intracellular cytokine staining (ICS).
Measured: At Month 4
Anti-glycoprotein E (Anti-gE) Geometric Mean Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Measured: At Month 4
Anti-gE Mean Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).
Measured: At Month 4

Secondary outcomes (7)

Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens
The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma [IFN-γ], Interleukin 2 [IL-2], Tumour Necrosis Factor alpha [TNF-α] and/or CD40 Ligand [CD40L] as determined by in vitro intracellular cytokine staining (ICS).
Measured: At Months 0, 1, 2, 3, 4 and 15
Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma [IFN-γ], Interleukin 2 [IL-2], Tumour Necrosis Factor alpha [TNF-α] and/or CD40 Ligand [CD40L] as determined by in vitro intracellular cytokine staining (ICS).
Measured: At Months 0, 1, 2, 3 and 15
Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Measured: At Months 0, 1, 2, 3, 4 and 15
VZV-specific Mean Antibody Concentrations
Concentrations are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).
Measured: At Months 0, 1, 2, 3, 4 and 15
Anti-gE Geometric Mean Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Measured: At Months 0, 1, 2, 3 and 15
Anti-gE Mean Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).
Measured: At Months 0, 1, 2, 3 and 15
Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
A suspected case of HZ could be confirmed by PCR and/or by clinical review of the GSK physician responsible for the study. Rash lesion samples collected from subjects clinically diagnosed as having a suspected case of HZ were tested by by polymerase chain reaction (PCR) using standardized and validated procedures for the laboratory diagnosis of HZ. If the PCR specimen was inadequate or was missing, suspected HZ cases were to be classified as 'a confirmed case of HZ' or 'not a case of HZ' based on the determination by the GSK responsible physician of the study.
Measured: During the entire study period (from Day 0 to Month 15)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 200921 Mar 2012

First posted15 Jun 2009 (estimated)
Study start14 Jul 2009
Primary completion26 Apr 2011
Study completion21 Mar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Herpes ZosterStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00920218
Sponsor's protocol ID: 110258
Status last verified: Aug 2017
First submitted: 12 Jun 2009
Last updated: 12 Dec 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 25237196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine

All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A
ClinicalTrials.gov ID: NCT00920218
Acronym / sponsor ID: 110258
Conditions: Herpes Zoster
Keywords: Vaccine, Safety, Herpes Zoster, Immunogenicity, Stem cell transplantation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 14 Jul 2009 (actual)
Primary completion: 26 Apr 2011 (actual)
Study completion: 21 Mar 2012 (actual)
First posted: 15 Jun 2009 (estimated)
Results: Posted 12 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
GSK 1437173A F1 Group	Experimental	Biological: Herpes Zoster Vaccine 1437173AMale 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.
GSK 1437173A F2 Group	Experimental	Biological: Herpes Zoster Vaccine 1437173AMale 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.
Placebo-GSK 1437173A F1 Group	Experimental	Biological: Herpes Zoster Vaccine 1437173A, Biological: Placebo vaccine (saline)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.
Placebo Group	Placebo comparator	Biological: Placebo vaccine (saline)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Herpes Zoster Vaccine 1437173ADifferent formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.	Biological	GSK 1437173A F1 Group, GSK 1437173A F2 Group, Placebo-GSK 1437173A F1 Group
Placebo vaccine (saline)1 or 3 doses of Placebo (saline) injected intramuscularly.	Biological	Placebo Group, Placebo-GSK 1437173A F1 Group

Primary outcome

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms [including nausea, vomiting, diarrhoea and abdominal pain], temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs)
Time frame: During the 30-day (Days 0-29) post-vaccination period
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Any time during the study up to Day 29 after the last vaccination
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 up to Month 15)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders
Time frame: Within the 30-day (Days 0-29) post last vaccination period
Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders
Time frame: During the entire study period (from Day 0 to Month 15)
Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Time frame: At Month 0
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Time frame: At Month 1
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Time frame: At Month 2
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Time frame: At Month 3
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Time frame: At Month 4
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
Time frame: At Month 4
The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma [IFN-γ], Interleukin 2 [IL-2], Tumour Necrosis Factor alpha [TNF-α] and/or CD40 Ligand [CD40L] as determined by in vitro intracellular cytokine staining (ICS).
Anti-glycoprotein E (Anti-gE) Geometric Mean Antibody Concentrations
Time frame: At Month 4
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Anti-gE Mean Antibody Concentrations
Time frame: At Month 4
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).

7 secondary outcomes

Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens
Time frame: At Months 0, 1, 2, 3, 4 and 15
Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
Time frame: At Months 0, 1, 2, 3 and 15
Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations
Time frame: At Months 0, 1, 2, 3, 4 and 15
VZV-specific Mean Antibody Concentrations
Time frame: At Months 0, 1, 2, 3, 4 and 15
Anti-gE Geometric Mean Antibody Concentrations
Time frame: At Months 0, 1, 2, 3 and 15
Anti-gE Mean Antibody Concentrations
Time frame: At Months 0, 1, 2, 3 and 15
Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
Time frame: During the entire study period (from Day 0 to Month 15)

Results and safety

Results posted to the registry on 12 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK 1437173A F1 Group	30	28
GSK 1437173A F2 Group	29	24
Placebo-GSK 1437173A F1 Group	31	23
Placebo Group	30	23

Primary outcome: Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Time frame: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses. Count of participants. Unit: Participants

Measure	GSK 1437173A F1 Group n = 30	GSK 1437173A F2 Group n = 29	GSK 1437173A 2D Group n = 28	Placebo 1D Group n = 30	Placebo Group n = 30
Any Pain, Dose 1	25	19	22	4	3
Grade 3 Pain, Dose 1	0	3	1	0	0
Any Redness, Dose 1	2	6	2	1	0
Grade 3 Redness, Dose 1	0	0	0	0	0
Any Swelling, Dose 1	1	3	4	0	0
Grade 3 Swelling, Dose 1	0	0	0	0	0
Any Pain, Dose 2	24	19	22	–	3
Grade 3 Pain, Dose 2	2	3	1	–	0

Population analysed: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Primary outcome: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Time frame: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses. Count of participants. Unit: Participants

Measure	GSK 1437173A F1 Group n = 30	GSK 1437173A F2 Group n = 29	GSK 1437173A 2D Group n = 28	Placebo 1D Group n = 30	Placebo Group n = 30
Any Fatigue, Dose 1	13	11	12	15	7
Grade 3 Fatigue, Dose 1	1	1	0	1	0
Related Fatigue, Dose 1	5	7	8	6	1
Any Gastr. sympt., Dose 1	6	4	1	9	2
Grade 3 Gastr. sympt., Dose 1	0	0	0	0	0
Related Gastr. sympt., Dose 1	3	2	1	3	1
Any Headache, Dose 1	4	1	4	7	2
Grade 3 Headache, Dose 1	0	0	0	0	0

Primary outcome: Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs)

Time frame: During the 30-day (Days 0-29) post-vaccination period. Count of participants. Unit: Participants

Measure	GSK 1437173A F1 Group n = 30	GSK 1437173A F2 Group n = 29	GSK 1437173A 2D Group n = 29	Placebo 1D Group n = 31	Placebo Group n = 30
Any AEs	25	23	22	16	21
Grade 3 AEs	5	6	2	1	4

Population analysed: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Primary outcome: Number of Subjects With Serious Adverse Events (SAEs)

Time frame: Any time during the study up to Day 29 after the last vaccination. Count of participants. Unit: Participants

Measure	GSK 1437173A F1 Group n = 30	GSK 1437173A F2 Group n = 29	GSK 1437173A 2D Group n = 29	Placebo 1D Group n = 31	Placebo Group n = 30
Value	3	5	2	1	2

Population analysed: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK 1437173A F1 Group	6 of 30 (20%)	29 of 30 (96.7%)	3 of 30
GSK 1437173A F2 Group	9 of 29 (31%)	27 of 29 (93.1%)	1 of 29
Placebo-GSK 1437173A F1 Group	10 of 31 (32.3%)	29 of 31 (93.5%)	2 of 31
Placebo Group	8 of 30 (26.7%)	21 of 30 (70%)	3 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25237196Stadtmauer 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Herpes Zoster Vaccine 1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Any and Grade 3 Solicited Local Symptoms (time frame: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00920218, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.