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Herpes ZosterPhase 3NCT01798056

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy

A Phase 3 study testing GSK 1437173A in people with Herpes Zoster and Herpes Zoster Vaccine, run by GlaxoSmithKline at 28 sites in 6 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults with solid tumours undergoing chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Herpes Zoster, Herpes Zoster Vaccine
What is being tested?
GSK 1437173A
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
237 participants
Where
28 sitesin 6 countries
Study dates
6 Mar 2013to 20 May 2016
Phase
Phase 3
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, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • A male or female aged 18 years or older (and has reached the age of legal consent) at the time of study entry (i.e., when informed consent is signed).
  • Subject who has been diagnosed with one or more solid tumours (defined as a solid malignancy, i.e., not a blood element malignancy).
  • Subject who is receiving or will receive a cytotoxic or immunosuppressive chemotherapy (such that the study vaccine can be administered at the latest at the start of the second cycle of chemotherapy).
  • Life expectancy of greater than one year.
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  • Female subjects of non-childbearing potential may be enrolled in the study:
  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause;
  • 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.

Who cannot join

  • Subjects receiving only newer, more targeted therapies if not taken together with a classical chemotherapy.
  • Chronic administration and/or planned administration of systemic glucocorticoids within one month prior to the first vaccine dose and up to Visit 3 (Month 2). Inhaled, intra-articularly injected, and topical steroids are allowed.
  • Previous vaccination against HZ or varicella within 12 months preceding the first dose of study vaccine/ placebo.
  • Planned administration during the study of a HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
  • Previous chemotherapy course less than one month before first study vaccination.
  • Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/ placebo.
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  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment.
  • Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
  • HIV infection by clinical history.
  • Acute disease and/or fever at the time of vaccination. Acute disease is defined as the presence of a moderate or severe illness with or without fever, but excludes the underlying malignancy, as well as the expected symptoms/signs associated with that disease or its treatment:
  • Fever is defined as temperature ≥ 37.5°C /99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C /100.4°F on rectal setting. The preferred route for recording temperature in this study will be oral.
  • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever, may receive the first dose of study vaccine/ placebo at the discretion of the investigator.
  • Any condition which, in the judgment of the investigator would make intramuscular injection unsafe.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3 (i.e., 2 months after the last dose of study vaccine/ placebo).

Trial locations and contacts

28 sites in 6 countries.

28 sites in 6 countries

Spain11 sites

  • GSK Investigational Site

    Badajoz, 6080

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28050

  • GSK Investigational Site

    Majadahonda (Madrid), 28222

  • GSK Investigational Site

    Móstoles, 28935

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

  • GSK Investigational Site

    San Sebastián de los Reyes, 28702

Other trials in Spain

United Kingdom6 sites

  • GSK Investigational Site

    Cheltenham, Gloucestershire, GL53 7AN

  • GSK Investigational Site

    Exeter, EX2 5DW

  • GSK Investigational Site

    Sheffield, S10 2SJ

  • GSK Investigational Site

    Swindon, Wiltshire, SN3 6BB

  • GSK Investigational Site

    Woolwich, London, SE18 4QH

  • GSK Investigational Site

    York, YO31 8HE

Other trials in United Kingdom

France4 sites

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Férolles-Attilly, 77150

  • GSK Investigational Site

    Lyon, 69373

  • GSK Investigational Site

    Nîmes, 30029

Other trials in France

Canada3 sites

  • GSK Investigational Site

    Halifax, Nova Scotia, B3K 6R8

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

  • GSK Investigational Site

    Toronto, Ontario, M4C 3E7

Other trials in Canada

South Korea3 sites

  • GSK Investigational Site

    Seoul, 02841

  • GSK Investigational Site

    Seoul, 03080

  • GSK Investigational Site

    Seoul, 05505

Other trials in South Korea

Czechia1 site

  • GSK Investigational Site

    Prague, 180 00

Other trials in Czechia

About this study

Official title: An Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults 18 Years of Age or Older With Solid Tumours Receiving Chemotherapy

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults with solid tumours undergoing chemotherapy.

Read the detailed description

The study will be randomised into two groups based on the vaccination schedule in relation to the start of a chemotherapy cycle:

  • The OnChemo group receives their first HZ/su vaccination at the start of a chemotherapy cycle,
  • The PreChemo group receives their first HZ/su vaccination at least 10 days before the start of a chemotherapy cycle.

The protocol summary has been updated following Protocol Amendment 2, August 2014, leading to the increase of the enrolment.

Being tested
GSK 1437173A, Placebo
Keywords
≥18 years of age, Chemotherapy, Solid tumours, Immunogenicity, Herpes Zoster, Safety, Shingles
Medical subject headings
Herpes Zoster

What participants receive

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

  • GSK 1437173ABiological

    Also called HZ/su, GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine

    2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.

  • PlaceboDrug

    2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.

Study groups in NCT01798056
Study groupRoleWhat they receive
GSK1437173A GroupExperimentalSubjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Receives: Biological: GSK 1437173A
Placebo GroupPlacebo comparatorSubjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Receives: Drug: Placebo

What is being measured

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

  1. Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups

    Adjusted geometric means (GMC) of GSK1437173A over placebo for anti-glycoprotein E (gE) antibody enzyme-linked immunosorbent assay (ELISA) concentrations in PreChemo Groups only.

    Measured: At Month 2

  2. Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations

    Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL.

    Measured: At Month 2

  3. 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 every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

    Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

  4. Number of Days With Solicited Local Symptoms

    The number of days with any local symptoms has been assessed during the post-vaccination period.

    Measured: During the 7-day (Days 0-6) post-vaccination period following each dose

  5. 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 fever [defined as oral, axillary or tympanic temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. 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: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

  6. Number of Days With Solicited General Symptoms

    The number of days with any general symptoms has been assessed during the post-vaccination period.

    Measured: During the 7-day (Days 0-6) post-vaccination period following each dose

  7. Number of Subjects With Any, Grade 3 and Related 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. Related = AE assessed by the investigator as related to the vaccination.

    Measured: During the 30-day (Days 0-29) post-vaccination period

  8. 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. Related SAE= SAE assessed by the investigator as causally related to the study vaccination.

    Measured: From first dose up to 30 days post last vaccination

  9. Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)

    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMDs assessed by the investigator as causally related to the study vaccination.

    Measured: From first vaccination up to 30 days post last vaccination

Secondary outcomes (6)

  1. Anti-VZV gE Antibody Concentrations

    Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL.

    Measured: At Months 0, 1, 6 and 13

  2. Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations

    Vaccine response defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/ml); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.

    Measured: At Months 1, 2, 6 and 13

  3. Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups

    Descriptive statistics were tabulated for CD4[2+] cells, which are gE specific CD4+ T-cells with at least two activation markers ([2+]), expressed from the activation markers interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40-ligand (CD40-L), as determined by intracellular cytokine staining (ICS) method.

    Measured: At Months 0, 1, 2 and 13

  4. Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups

    Vaccine response defined as: For initially seronegative subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x320 Events/10E6 CD4+ T cells); For initially seropositive subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.

    Measured: At Months 1, 2 and 13

  5. Number of Subjects With Serious Adverse Events (SAEs)

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.

    Measured: From 30 days post last vaccination up to study end (Month 13)

  6. Number of Subjects With Any Potential Immune Mediated Diseases (pIMDs)

    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

    Measured: From 30 days post last vaccination up to study end (Month 13)

Timeline

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

  1. First posted25 Feb 2013 (estimated)
  2. Study start6 Mar 2013
  3. Primary completion18 Jun 2015
  4. Study completion20 May 2016

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
237 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01798056
Sponsor's protocol ID
116427
Other IDs
2012-002966-11
Status last verified
Apr 2021
First submitted
14 Feb 2013
Last updated
13 May 2021
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Vink P, Delgado Mingorance I, Maximiano Alonso C, Rubio-Viqueira B, Jung KH, Rodriguez Moreno JF, Grande E, Marrupe Gonzalez D, Lowndes S, Puente J, Kristeleit H, Farrugia D, McNeil SA, Campora L, Di Paolo E, El Idrissi M, Godeaux O, Lopez-Fauqued M, Salaun B, Heineman TC, Oostvogels L; Zoster-028 Study Group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial. Cancer. 2019 Apr 15;125(8):1301-1312. doi: 10.1002/cncr.31909. Epub 2019 Feb 1.

    PubMed 30707761

  • Hirsch C, Zorger AM, Baumann M, Park YS, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with solid tumours. Cochrane Database Syst Rev. 2025 Apr 16;4(4):CD015551. doi: 10.1002/14651858.CD015551.pub2.

    PubMed 40237463

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK 1437173A in people with Herpes Zoster and Herpes Zoster Vaccine, run by GlaxoSmithKline at 28 sites in 6 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 12 inclusion and 15 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 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Spain, United Kingdom, France, Canada, South Korea and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Aug 2018). 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?

Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups (time frame: At Month 2). The study lists 9 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 NCT01798056, which also lists 2 linked publications.

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 13 May 2021.

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