Herpes ZosterPhase 2NCT01165203
Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects
A Phase 2 study testing Herpes Zoster Vaccine GSK1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 15 sites in 3 countries.
Trial summary
This observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, firstly enrolling subjects treated with antiretroviral therapy (ART) and with high CD4 T cell… 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 GSK1437173A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 30 Sep 2010to 14 May 2013
- 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;
- Subjects born before 1985 and not from a tropical region. Subjects born in 1985 or later and subjects born before 1985 in tropical regions must have a history of Varicella Zoster virus (VZV) infection or serological evidence of prior VZV infection;
- Written informed consent obtained from the subject;
- Female subjects of non-childbearing potential may be enrolled in the study; Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series;
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- Known to be human immunodeficiency virus-1 (HIV-1) infected, diagnosed at least 1 year prior to enrolment;
- For the antiretroviral therapyART High CD4 and ART Low CD4 cohorts:
- Stable on ART for at least one year
- CD4 T cell count >= 50 cells /mm3 at screening
- Undetectable VL at screening;
- For the non-ART High CD4 cohort:
- ART-naïve subjects who have never received anti-retroviral therapy after HIV diagnosis and for whom commencement of ART is not expected based on current assessment within next seven months;
- HIV VL >= 1000 copies/mL and <= 100 000 copies/mL at screening
- CD4 T cell count >= 500 cells/mm3 at screening.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period;
- Vaccination against varicella or herpes zoster (HZ) within the previous 12 months;
- Occurrence of a varicella or HZ episode within the previous 12 months;
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation. Please note, the vaccine and vials in this study do not contain latex;
- Has currently an Acquired Immunodeficiency Syndrome (AIDS) defining condition;
- Opportunistic infection or AIDS-associated malignancy in the previous year;
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- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease other than HIV infection or immunosuppressive/cytotoxic therapy;
- Administration of immunoglobulins, and/or any blood products within 90 days preceding the first dose of study vaccine/placebo or planned administration during the study period;
- Chronic administration of immunosuppressive or other immune-modifying drugs within 6 months prior to the first vaccine dose;
- Administration and/or planned administration of a vaccine not foreseen by the study protocol within 30 days before dose 1, dose 2 and/or 3 of vaccine and/or within 30 days after any dose. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1, 2 and/or 3, and/or at least 14 days after any dose of study vaccine;
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product;
- Acute disease at the time of enrolment;
- Any contraindication to receiving intramuscular injections;
- Any condition or illness which might interfere with the evaluation of the safety or immunogenicity of the vaccine;
- Active hepatitis B (HBV) infection or active hepatitis C (HCV) infection.
- Current use of HIV fusion inhibitors, chemokine (C-C motif) receptor (CCR5) inhibitors or Interleukin-2/ Interleukin-7/ Interferon;
- For subjects in the ART cohorts, any change in anti-retroviral drug regimen within 12 weeks prior to vaccination;
- Pregnant or lactating female;
- Female planning to become pregnant or planning to discontinue contraceptive precautions;
- Abnormal biochemical and hematological laboratory values obtained for blood samples collected at screening.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
Germany6 sites
GSK Investigational Site
Berlin, 13353
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40237
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122
GSK Investigational Site
Hamburg, 20146
GSK Investigational Site
Hanover, Lower Saxony, 30625
United States5 sites
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Long Beach, California, 90813
GSK Investigational Site
Orlando, Florida, 32803
GSK Investigational Site
San Francisco, California, 94115
GSK Investigational Site
Santa Fe, New Mexico, 87505
United Kingdom4 sites
GSK Investigational Site
London, E1 1BB
GSK Investigational Site
London, NW3 2QG
GSK Investigational Site
London, SW10 9TH
GSK Investigational Site
Woolwich, London, London, SE18 4QH
About this study
Official title: Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A in Adult HIV-infected Subjects
This observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, firstly enrolling subjects treated with antiretroviral therapy (ART) and with high CD4 T cell counts, and subsequently ART-treated subjects with low CD4 T cell counts, and ART-naïve subjects with high CD4 T cell counts.
This Protocol Posting has been updated following Amendment 1 of the Protocol, August 2010. The impacted sections is exclusion criteria.
- Conditions
- Herpes Zoster
- Being tested
- Herpes Zoster Vaccine GSK1437173A, Placebo
- Keywords
- immunogenicity, vaccine, safety, HIV, Herpes Zoster
- 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 GSK1437173ABiological
Also called HZ/su vaccine
intramuscular injection
PlaceboBiological
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| GSK1437173A Group | Experimental | Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. Receives: Biological: Herpes Zoster Vaccine GSK1437173A |
| Placebo Group | Placebo comparator | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: From Month 0 to Month 18
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine
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: From screening (up to 21 days prior to Month 0) until Month 18
Number of Subjects With Any Fatal 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: From screening (up to 21 days prior to Month 0) until Month 18
Number of Subjects With Any Adverse Events (AEs) of Specific Interest
AEs of specific interest include new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo.
Measured: From Month 0 until Month 18
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of their 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: Within the 7-day (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 included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral/axillary temperature above (>) 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Unsolicited 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. Related = AE assessed by the investigator as related to the vaccination.
Measured: Within 30 days (Days 0-29) after each vaccination
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Measured: At Screening Visit (up to 21 days prior to Month 0)
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Measured: At Month 1
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Measured: At Month 2
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.
Measured: At Month 3
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Measured: At Month 6
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.
Measured: At Month 7
Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects
In this analysis, results were tabulated for the main study groups. Significant changes to ART appeared due to failure to control HIV viral load and due to failure to maintain high CD4 cells count.
Measured: From Month 0 until Month 18
Number of Subjects With Any AIDS-defining Condition
In this analysis, results were tabulated for the main study groups.
Measured: From Month 0 until Month 18
Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count
In this analysis, results were tabulated for the main study groups.
Measured: From Month 1 to Month 7
Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status
In this analysis, results were tabulated by HIV status
Measured: From Month 0 to Month 18
Number of Subjects With Any AIDS-defining Condition, by HIV Status
In this analysis, results were tabulated by HIV status
Measured: From Month 0 to Month 18
Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status
In this analysis, results were tabulated by HIV status.
Measured: From Month 1 to Month 7
Frequency of gE-specific CD4 T-cells
The analysis focused on CD4 T-cells expressing at least 2 cytokines (among interferon-gamma (IFN-g) , interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and/or CD40 ligand (CD40L)) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrollment.
Measured: At Month 7
-Anti-gE Antibody (Ab) Concentrations
-Anti-gE antibody (Ab) concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment. Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Measured: At Month 7
Secondary outcomes (7)
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
The analysis focused on CD4 T cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated for the main study groups.
Measured: At Month 0, 1, 2, 3, 6, 7 and 18
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
The analysis focused on CD4 T-cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated by HIV status.
Measured: At Months 0, 1, 2, 3, 6, 7 and 18
-Anti-VZV and Anti-gE Antibody Concentrations
Antibody concentrations were as determined by ELISA and tabulated for the main study groups. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.
Measured: At Months 0, 1, 2, 3, 6, 7 and 18
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Antibody concentrations were as determined by ELISA and tabulated by HIV status. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.
Measured: At Months 0, 1, 2, 3, 6, 7 and 18
Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications
Measured: From Month 0 until Month 18
CD4 Count
CD4 count was tabulated by HIV status.
Measured: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18
HIV VL
HIV VL was tabulated by HIV status, for subjects with a number of available results greater than or equal to (≥) 40 copies/mL.
Measured: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study start30 Sep 2010
- Primary completion6 Jul 2012
- Study completion14 May 2013
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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165203
- Sponsor's protocol ID
- 112673
- Status last verified
- Oct 2017
- First submitted
- 15 Jul 2010
- Last updated
- 30 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Berkowitz EM, Moyle G, Stellbrink HJ, Schurmann D, Kegg S, Stoll M, El Idrissi M, Oostvogels L, Heineman TC; Zoster-015 HZ/su Study Group. Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study. J Infect Dis. 2015 Apr 15;211(8):1279-87. doi: 10.1093/infdis/jiu606. Epub 2014 Nov 3.
PubMed 25371534
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. 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 in Adult HIV-infected Subjects
- ClinicalTrials.gov ID
- NCT01165203
- Acronym / sponsor ID
- 112673
- Conditions
- Herpes Zoster
- Keywords
- immunogenicity, vaccine, safety, HIV, Herpes Zoster
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2010 (actual)
- Primary completion
- 6 Jul 2012 (actual)
- Study completion
- 14 May 2013 (actual)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Posted 7 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, firstly enrolling subjects treated with antiretroviral therapy (ART) and with high CD4 T cell counts, and subsequently ART-treated subjects with low CD4 T cell counts, and ART-naïve subjects with high CD4 T cell counts.
This Protocol Posting has been updated following Amendment 1 of the Protocol, August 2010. The impacted sections is exclusion criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK1437173A Group | Experimental | Biological: Herpes Zoster Vaccine GSK1437173ASubjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
| Placebo Group | Placebo comparator | Biological: PlaceboSubjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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;
- Subjects born before 1985 and not from a tropical region. Subjects born in 1985 or later and subjects born before 1985 in tropical regions must have a history of Varicella Zoster virus (VZV) infection or serological evidence of prior VZV infection;
- Written informed consent obtained from the subject;
- Female subjects of non-childbearing potential may be enrolled in the study; Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Key exclusion criteria (20 listed)
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period;
- Vaccination against varicella or herpes zoster (HZ) within the previous 12 months;
- Occurrence of a varicella or HZ episode within the previous 12 months;
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation. Please note, the vaccine and vials in this study do not contain latex;
- Has currently an Acquired Immunodeficiency Syndrome (AIDS) defining condition;
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 GSK1437173AAlso: HZ/su vaccineintramuscular injection | Biological | GSK1437173A Group |
| Placebointramuscular injection | Biological | Placebo Group |
Primary outcome
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Month 0 to Month 18
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 SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine
Time frame: From screening (up to 21 days prior to Month 0) until Month 18
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 Fatal SAEs
Time frame: From screening (up to 21 days prior to Month 0) until Month 18
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 Adverse Events (AEs) of Specific Interest
Time frame: From Month 0 until Month 18
AEs of specific interest include new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo.
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Time frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of their 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: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral/axillary temperature above (>) 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Unsolicited AEs
Time frame: Within 30 days (Days 0-29) after each vaccination
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. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Time frame: At Screening Visit (up to 21 days prior to Month 0)
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Time frame: At Month 1
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Time frame: At Month 2
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Time frame: At Month 3
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Time frame: At Month 6
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Time frame: At Month 7
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.
Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects
Time frame: From Month 0 until Month 18
In this analysis, results were tabulated for the main study groups. Significant changes to ART appeared due to failure to control HIV viral load and due to failure to maintain high CD4 cells count.
Number of Subjects With Any AIDS-defining Condition
Time frame: From Month 0 until Month 18
In this analysis, results were tabulated for the main study groups.
Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count
Time frame: From Month 1 to Month 7
In this analysis, results were tabulated for the main study groups.
Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status
Time frame: From Month 0 to Month 18
In this analysis, results were tabulated by HIV status
Number of Subjects With Any AIDS-defining Condition, by HIV Status
Time frame: From Month 0 to Month 18
In this analysis, results were tabulated by HIV status
Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status
Time frame: From Month 1 to Month 7
In this analysis, results were tabulated by HIV status.
Frequency of gE-specific CD4 T-cells
Time frame: At Month 7
The analysis focused on CD4 T-cells expressing at least 2 cytokines (among interferon-gamma (IFN-g) , interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and/or CD40 ligand (CD40L)) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrollment.
-Anti-gE Antibody (Ab) Concentrations
Time frame: At Month 7
-Anti-gE antibody (Ab) concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment. Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
7 secondary outcomes
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
Time frame: At Month 0, 1, 2, 3, 6, 7 and 18
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
Time frame: At Months 0, 1, 2, 3, 6, 7 and 18
-Anti-VZV and Anti-gE Antibody Concentrations
Time frame: At Months 0, 1, 2, 3, 6, 7 and 18
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Time frame: At Months 0, 1, 2, 3, 6, 7 and 18
Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications
Time frame: From Month 0 until Month 18
CD4 Count
Time frame: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18
HIV VL
Time frame: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25371534Berkowitz EM, Moyle G, Stellbrink HJ, Schurmann D, Kegg S, Stoll M, El Idrissi M, Oostvogels L, Heineman TC; Zoster-015 HZ/su Study Group. Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study. J Infect Dis. 2015 Apr 15;211(8):1279-87. doi: 10.1093/infdis/jiu606. Epub 2014 Nov 3.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Herpes Zoster Vaccine GSK1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 15 sites in 3 countries.
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 15 inclusion and 20 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 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, United States, United Kingdom. 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 7 Jun 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 Serious Adverse Events (SAEs) (time frame: From Month 0 to Month 18). The study lists 21 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 NCT01165203, 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 30 Apr 2018.