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NCT01777321

Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Intramuscularly in Adults Aged ≥50 Years

Completed Phase 3 Results posted Last updated 25 October 2018
What this trial tests

Phase 3 trial testing Herpes zoster vaccine GSK1437173A in Herpes Zoster in 60 participants. Completed in 11 November 2014.

Timeline
17 June 2013
Primary endpoint
10 October 2013
11 November 2014

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment60
Start date17 June 2013
Primary completion10 October 2013
Estimated completion11 November 2014
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

50 and older, any sex, with Herpes Zoster. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) Primary · Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)

A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value, of 18 mIU/mL.

Anti-gE, PRE
GroupValue95% CI
SC GSK1437173A Group29
IM GSK1437173A Group29
Anti-gE, M2
GroupValue95% CI
SC GSK1437173A Group29
IM GSK1437173A Group29
Anti-gE, M3
GroupValue95% CI
SC GSK1437173A Group29
IM GSK1437173A Group29
Anti-gE Antibody Concentrations Primary · Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)

Anti-gE antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.

Anti-gE, PRE
GroupValue95% CI
SC GSK1437173A Group1424.31042.6 – 1945.6
IM GSK1437173A Group1116.8774.5 – 1610.3
Anti-gE, M2
GroupValue95% CI
SC GSK1437173A Group19902.514846.9 – 26679.6
IM GSK1437173A Group128428558.4 – 19269.7
Anti-gE, M3
GroupValue95% CI
SC GSK1437173A Group44126.136326.1 – 53601
IM GSK1437173A Group45521.537549.5 – 55185.9
Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations Primary · At two months after Dose 1 (M2) and one month after Dose 2 (M3)

Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.

Anti-gE, M2
GroupValue95% CI
SC GSK1437173A Group28
IM GSK1437173A Group25
Anti-gE, M3
GroupValue95% CI
SC GSK1437173A Group29
IM GSK1437173A Group29
Descriptive Statistics of Anti-gE Antibody Concentrations Primary · Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3)

Anti-gE antibody concentrations were assessed by the Enzyme Lynked Immunosorbent Assay.

Anti-gE, PRE
GroupValue95% CI
SC GSK1437173A Group1404.1± 1398.82
IM GSK1437173A Group946.3± 3231.78
Anti-gE, M2
GroupValue95% CI
SC GSK1437173A Group19400.1± 24456.86
IM GSK1437173A Group14330.1± 14548.75
Anti-gE, M3
GroupValue95% CI
SC GSK1437173A Group44182± 27990.99
IM GSK1437173A Group42444.8± 27555.21
Number of Subjects With Solicited Local Symptoms Primary · During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses

The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities.

Any Arm movement impairment, D1
GroupValue95% CI
SC GSK1437173A Group10
IM GSK1437173A Group7
Any Arm movement impairment, D2
GroupValue95% CI
SC GSK1437173A Group16
IM GSK1437173A Group11
Any Arm movement impairment, Across
GroupValue95% CI
SC GSK1437173A Group18
IM GSK1437173A Group12
Grade 3 Arm movement impairment, D1
GroupValue95% CI
SC GSK1437173A Group1
IM GSK1437173A Group0
Grade 3 Arm movement impairment, D2
GroupValue95% CI
SC GSK1437173A Group0
IM GSK1437173A Group0
Grade 3 Arm movement impairment, Across
GroupValue95% CI
SC GSK1437173A Group1
IM GSK1437173A Group0
Any Injection site pruritus, D1
GroupValue95% CI
SC GSK1437173A Group19
IM GSK1437173A Group6
Any Injection site pruritus, D2
GroupValue95% CI
SC GSK1437173A Group15
IM GSK1437173A Group8
Number of Subjects With Solicited General Symptoms Primary · During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses

Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature higher than (\>) 39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination.

Any Fatigue, D1
GroupValue95% CI
SC GSK1437173A Group14
IM GSK1437173A Group12
Any Fatigue, D2
GroupValue95% CI
SC GSK1437173A Group16
IM GSK1437173A Group9
Any Fatigue, Across
GroupValue95% CI
SC GSK1437173A Group21
IM GSK1437173A Group16
Grade 3 Fatigue, D1
GroupValue95% CI
SC GSK1437173A Group0
IM GSK1437173A Group0
Grade 3 Fatigue, D2
GroupValue95% CI
SC GSK1437173A Group0
IM GSK1437173A Group1
Grade 3 Fatigue, Across
GroupValue95% CI
SC GSK1437173A Group0
IM GSK1437173A Group1
Related Fatigue, D1
GroupValue95% CI
SC GSK1437173A Group14
IM GSK1437173A Group12
Related Fatigue, D2
GroupValue95% CI
SC GSK1437173A Group16
IM GSK1437173A Group9
Mean Number of Days With Local Symptoms Primary · During the 7 day (Days 0-6) post vaccination, after each dose (D)

Days with solicited local symptoms were tabulated for the total vaccinated cohort.

Days with arm movement, D1
GroupValue95% CI
SC GSK1437173A Group3.92 – 7
IM GSK1437173A Group32 – 3
Days with pain, D1
GroupValue95% CI
SC GSK1437173A Group3.32 – 4
IM GSK1437173A Group2.72 – 3
Days with injection site pruritus, D1
GroupValue95% CI
SC GSK1437173A Group5.22 – 7
IM GSK1437173A Group2.21 – 3
Days with redness, D1
GroupValue95% CI
SC GSK1437173A Group6.54 – 8
IM GSK1437173A Group2.62 – 3
Days with swelling, D1
GroupValue95% CI
SC GSK1437173A Group53 – 6
IM GSK1437173A Group32 – 3
Days with arm movement, D2
GroupValue95% CI
SC GSK1437173A Group2.92 – 3
IM GSK1437173A Group2.22 – 3
Days with pain, D2
GroupValue95% CI
SC GSK1437173A Group3.42 – 4
IM GSK1437173A Group2.31 – 3
Days with injection site pruritus, D2
GroupValue95% CI
SC GSK1437173A Group4.93 – 5
IM GSK1437173A Group1.91.5 – 2
Mean Number of Days With General Symptoms Primary · During the 7 day (Days 0-6) post vaccination, after each dose (D)

Days with solicited general symptoms were tabulated for the total vaccinated cohort.

Days with fatigue, D1
GroupValue95% CI
SC GSK1437173A Group2.31 – 3
IM GSK1437173A Group21 – 2
Days with fever, D1
GroupValue95% CI
SC GSK1437173A Group1.31 – 2
IM GSK1437173A Group11 – 1
Days with gastrointestinal symptoms, D1
GroupValue95% CI
SC GSK1437173A Group21 – 3
IM GSK1437173A Group22 – 2
Days with headache, D1
GroupValue95% CI
SC GSK1437173A Group1.81 – 2
IM GSK1437173A Group1.41 – 2
Days with myalgia, D1
GroupValue95% CI
SC GSK1437173A Group6.53 – 10
IM GSK1437173A Group22 – 2
Days with Shivering, D1
GroupValue95% CI
SC GSK1437173A Group1.31 – 2
IM GSK1437173A Group1.31 – 2
Days with fatigue, D2
GroupValue95% CI
SC GSK1437173A Group21 – 2
IM GSK1437173A Group1.31 – 2
Days with fever, D2
GroupValue95% CI
SC GSK1437173A Group11 – 1
IM GSK1437173A Group11 – 1
Number of Subjects With Potential Immune-Mediated Disorders (pIMDs) Primary · From Month 0 to Month 3

Potential immune-mediated diseases (pIMDs) were 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.

GroupValue95% CI
SC GSK1437173A Group0
IM GSK1437173A Group0
Number of Subjects With Unsolicited Adverse Events (AEs) Primary · Within 30 days (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. Related = AE assessed by the investiga

Any AEs
GroupValue95% CI
SC GSK1437173A Group9
IM GSK1437173A Group6
Grade 3 AEs
GroupValue95% CI
SC GSK1437173A Group1
IM GSK1437173A Group0
Related AEs
GroupValue95% CI
SC GSK1437173A Group1
IM GSK1437173A Group1
Number of Subjects With Serious Adverse Events (SAEs) Primary · From Month 0 to Month 3

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.

GroupValue95% CI
SC GSK1437173A Group1
IM GSK1437173A Group0
Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL Secondary · At Month 14

A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value of 97 mIU/mL.

GroupValue95% CI
SC GSK1437173A Group30
IM GSK1437173A Group28

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited symptoms: during the 7-day post-vaccination period; Unsolicited AEs: during the 30-day post-vaccination period; SAEs: up to Month 14 post vaccination.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SC GSK1437173A Group
Serious: 2/30 (7%)
Deaths: 0/30
IM GSK1437173A Group
Serious: 1/30 (3%)
Deaths: 0/30

Serious adverse events (3 terms)

ReactionSystemSC GSK1437173A GroupIM GSK1437173A Group
Spinal compression fractureInjury, poisoning and procedural complications——
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders——
Mallet fingerMusculoskeletal and connective tissue disorders——
Other adverse events (11 terms — click to expand)

ReactionSystemSC GSK1437173A GroupIM GSK1437173A Group
PainGeneral disorders——
RednessGeneral disorders——
SwellingGeneral disorders——
Injection site pruritusGeneral disorders——
FatigueGeneral disorders——
Arm movementGeneral disorders——
HeadacheGeneral disorders——
ShiveringGeneral disorders——
Fever/(Axillary)General disorders——
Gastrointestinal symptomsGeneral disorders——
Myalgia (muscle aches)General disorders——

Most-reported serious reactions: Spinal compression fracture, Chronic obstructive pulmonary disease, Mallet finger.

Data from ClinicalTrials.gov NCT01777321 adverse events section.

Sponsor's own description

The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC) as compared to intramuscularly (IM) to people 50 years of age and older.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Vaccines for preventing herpes zoster in older adults.
    Gagliardi AM, Andriolo BN, Torloni MR, Soares BG, et al · · 2019 · cited 42× · PMID 31696946 · DOI 10.1002/14651858.cd008858.pub4
  2. Vaccines for preventing herpes zoster in older adults.
    Gagliardi AM, Andriolo BN, Torloni MR, Soares BG. · · 2016 · cited 29× · PMID 26937872 · DOI 10.1002/14651858.cd008858.pub3
  3. Safety and immunogenicity of a Herpes Zoster subunit vaccine in Japanese population aged ≥50 years when administered subcutaneously vs. intramuscularly.
    Vink P, Shiramoto M, Ogawa M, Eda M, et al · · 2017 · cited 20× · PMID 27936344 · DOI 10.1080/21645515.2016.1232787
  4. Vaccines for preventing herpes zoster in older adults.
    de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, et al · · 2023 · cited 18× · PMID 37781954 · DOI 10.1002/14651858.cd008858.pub5

Verify or expand the search:

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing