Herpes ZosterPhase 3NCT01751165
Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older
A Phase 3 study testing Herpes zoster vaccine GSK1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 4 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- 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?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 Mar 2013to 8 Apr 2015
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- 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.
- A male or female aged 50 years or older at the time of the first vaccination.
- 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 pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
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- 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 two months after completion of the vaccination series.
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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, a prednisone dose of < 20 mg/day, or equivalent, is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
- Administration or planned administration of a live vaccine in the period starting 30 days before and ending 30 days after either dose of study vaccine.
- Administration or planned administration of a non-replicating vaccine within eight days prior to or within 14 days after either dose of study vaccine.
- Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.
- Previous vaccination against varicella or HZ (either registered product or participation in a previous vaccine study).
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- Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
- History of HZ.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g. malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g. medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C (99.5°F) for oral, axillary or tympanic route, or ≥ 38.0°C (100.4°F) for rectal route. 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 be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.
- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
- Pregnant or lactating female.
- Female planning to become pregnant during the entire treatment period and for two months after completion of the vaccination series, or planning to discontinue contraceptive precautions (if of childbearing potential).
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
GSK Investigational Site
Spring Valley, California, 91978
GSK Investigational Site
Uniontown, Pennsylvania, 15401
GSK Investigational Site
Wichita, Kansas, 67207
About this study
Official title: Open-label Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.
Read the detailed description
Subjects in each group will be stratified by age with a minimum of 35 subjects in each stratum (50-59 years of age (YOA) stratum, 60-69 YOA stratum and ≥ 70 YOA stratum).
- Conditions
- Herpes Zoster
- Being tested
- Herpes zoster vaccine GSK1437173A
- Keywords
- ≥ 50 years of age, Herpes zoster, Safety, Immunogenicity, Adults
- 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
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
| Study group | Role | What they receive |
|---|---|---|
| HZ/su-0,2 Group | Experimental | Subjects will receive HZ/su vaccine on a 0,2-month schedule. Receives: Biological: Herpes zoster vaccine GSK1437173A |
| HZ/su-0,6 Group | Experimental | Subjects will receive HZ/su vaccine on a 0,6-month schedule. Receives: Biological: Herpes zoster vaccine GSK1437173A |
| HZ/su-0,12 Group | Experimental | Subjects will receive HZ/su vaccine on a 0,12-month schedule. Receives: Biological: Herpes zoster vaccine GSK1437173A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA).
Vaccine response was 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.
The objective required a comparison of VRR between 0,6-months and 0,12-months schedules.
Measured: At one month (M1) after Dose 2
Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
Measured: At one month (M1) after Dose 2
Secondary outcomes (10)
Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
Measured: Prior (PRE) to vaccination and twelve (M12) post Dose 2
Number of Subjects With Solicited Local Symptoms.
Solicited local symptoms assessed include pain, redness and swelling. "Grade 3 pain" was defined as crying when limb was moved/spontaneously painful. "Grade 3 swelling/redness" was defined as swelling/redness larger than (>) 100 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
Measured: During the 7 day period (Days 0-6) following each dose (D)
Number of Subjects With Solicited General Symptoms.
Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than [≥] 37.5 degrees Celsius [°C]). "Any" = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. "Related" = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. "Grade 3 Fatigue" = fatigue that prevented normal activity. "Grade 3 Gastrointestinal" = gastrointestinal that prevented normal every day activities. "Grade 3 Headache" = headache that prevented normal activity. "Grade 3 Myalgia" = myalgia that prevented normal activity. "Grade 3 Shivering" = shivering that prevented normal activity. "Grade 3 Temperature" = temperature higher than (>) 39.0°C.
Measured: During the 7 day period (Days 0-6) following each dose (D)
Number of Subjects With Unsolicited Adverse Events (AEs).
An adverse event (AE) is 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.
Measured: During the 30 Days (Day 0-29) following vaccination
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, result in disability/incapacity.
Measured: From first vaccination up to one month (30 Days) post last vaccination
Number of Subjects With SAE(s).
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
Measured: Starting from 30 Days post last vaccine administration up to study end at Month 24
Number of Days With Solicited Local Symptoms.
Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.
Measured: During the 7 Days (Day 0-6) following vaccination
Number of Days With Solicited General Symptoms.
Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.
Measured: During the 7 Days (Day 0-6) following vaccination
Number of Subjects With Potential Immune-mediated Diseases (pIMDs).
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 Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)
Number of Subjects With pIMDs.
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 one month (30 Days) following the last vaccine administration up to study end at Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study start12 Mar 2013
- Primary completion22 May 2014
- Study completion8 Apr 2015
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 354 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
- NCT01751165
- Sponsor's protocol ID
- 116697
- Other IDs
- 2012-004456-11
- Status last verified
- Jun 2018
- First submitted
- 13 Dec 2012
- Last updated
- 18 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Lal H, Poder A, Campora L, Geeraerts B, Oostvogels L, Vanden Abeele C, Heineman TC. Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study. Vaccine. 2018 Jan 2;36(1):148-154. doi: 10.1016/j.vaccine.2017.11.019. Epub 2017 Nov 22.
PubMed 29174683
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
- ClinicalTrials.gov ID
- NCT01751165
- Acronym / sponsor ID
- 116697
- Conditions
- Herpes Zoster
- Keywords
- ≥ 50 years of age, Herpes zoster, Safety, Immunogenicity, Adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2013
- Primary completion
- 22 May 2014 (actual)
- Study completion
- 8 Apr 2015 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.
Detailed description
Subjects in each group will be stratified by age with a minimum of 35 subjects in each stratum (50-59 years of age (YOA) stratum, 60-69 YOA stratum and ≥ 70 YOA stratum).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HZ/su-0,2 Group | Experimental | Biological: Herpes zoster vaccine GSK1437173ASubjects will receive HZ/su vaccine on a 0,2-month schedule. |
| HZ/su-0,6 Group | Experimental | Biological: Herpes zoster vaccine GSK1437173ASubjects will receive HZ/su vaccine on a 0,6-month schedule. |
| HZ/su-0,12 Group | Experimental | Biological: Herpes zoster vaccine GSK1437173ASubjects will receive HZ/su vaccine on a 0,12-month schedule. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female aged 50 years or older at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
Key exclusion criteria (18 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, a prednisone dose of < 20 mg/day, or equivalent, is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
- Administration or planned administration of a live vaccine in the period starting 30 days before and ending 30 days after either dose of study vaccine.
- Administration or planned administration of a non-replicating vaccine within eight days prior to or within 14 days after either dose of study vaccine.
- Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.
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 GSK1437173A2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm. | Biological | HZ/su-0,12 Group, HZ/su-0,2 Group, HZ/su-0,6 Group |
Primary outcome
Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: At one month (M1) after Dose 2
Vaccine response was 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. The objective required a comparison of VRR between 0,6-months and 0,12-months schedules.
Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
Time frame: At one month (M1) after Dose 2
10 secondary outcomes
Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
Time frame: Prior (PRE) to vaccination and twelve (M12) post Dose 2
Number of Subjects With Solicited Local Symptoms.
Time frame: During the 7 day period (Days 0-6) following each dose (D)
Number of Subjects With Solicited General Symptoms.
Time frame: During the 7 day period (Days 0-6) following each dose (D)
Number of Subjects With Unsolicited Adverse Events (AEs).
Time frame: During the 30 Days (Day 0-29) following vaccination
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: From first vaccination up to one month (30 Days) post last vaccination
Number of Subjects With SAE(s).
Time frame: Starting from 30 Days post last vaccine administration up to study end at Month 24
Number of Days With Solicited Local Symptoms.
Time frame: During the 7 Days (Day 0-6) following vaccination
Number of Days With Solicited General Symptoms.
Time frame: During the 7 Days (Day 0-6) following vaccination
Number of Subjects With Potential Immune-mediated Diseases (pIMDs).
Time frame: From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)
Number of Subjects With pIMDs.
Time frame: From one month (30 Days) following the last vaccine administration up to study end at Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29174683Lal H, Poder A, Campora L, Geeraerts B, Oostvogels L, Vanden Abeele C, Heineman TC. Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study. Vaccine. 2018 Jan 2;36(1):148-154. doi: 10.1016/j.vaccine.2017.11.019. Epub 2017 Nov 22.
- IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request 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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Herpes zoster vaccine GSK1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 4 sites in 2 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 9 inclusion and 18 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 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Estonia. 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. 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 31 Mar 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 Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA). (time frame: At one month (M1) after Dose 2). The study lists 2 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 NCT01751165, 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 18 Oct 2018.