Phase 2
N=714
Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT00434577 ↗Enrolled (actual)
714
Serious AEs
37.4%
Results posted
Jan 2019
Primary outcome: Primary: Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers — 1801.23; 1722.83; 1778.48; 491.03 T-cells/million cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Herpes Zoster vaccine GSK1437173A Low Dose (Biological); Herpes Zoster vaccine GSK1437173A Medium Dose (Biological); Herpes Zoster vaccine GSK1437173A High Dose (Biological); Herpes Zoster vaccine GSK1437173A Modified (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers |
1801.23; 1722.83; 1778.48; 491.03; 388.49 | — |
| PRIMARY Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers |
12.83; 15.00; 21.53; 5.92; 4.05 | — |
| PRIMARY Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers |
194.47; 225.47; 201.17; 203.70; 145.95; 459.01 | — |
| SECONDARY Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers |
194.47; 225.47; 201.17; 203.70; 145.95; 459.01 | — |
| SECONDARY Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker |
156.54; 169.01; 152.28; 157.13; 118.35; 279.39 | — |
| SECONDARY Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker |
171.21; 191.28; 180.85; 172.41; 125.22; 416.12 | — |
| SECONDARY Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker |
97.28; 121.05; 116.91; 110.66; 81.40; 251.94 | — |
| SECONDARY Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker |
142.88; 153.80; 151.37; 155.90; 111.55; 385.34 | — |
| SECONDARY Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers |
74.62; 98.88; 122.37; 80.54; 108.21; 85.29 | — |
| SECONDARY Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker |
60.35; 75.79; 106.39; 70.69; 123.99; 65.97 | — |
| SECONDARY Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker |
81.42; 83.13; 90.71; 63.56; 43.03; 61.05 | — |
| SECONDARY Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker |
74.94; 87.33; 111.54; 81.54; 122.68; 71.42 | — |
| SECONDARY Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker |
41.35; 61.30; 56.85; 35.96; 59.94; 63.87 | — |
| SECONDARY Anti-gE Specific Antibody Concentrations |
3384.8; 4280.3; 5258.2; 1664.5; 1888.2; 2363.8 | — |
| SECONDARY Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations |
4190.1; 4761.3; 5559.1; 2704.1; 2733.8; 2557.4 | — |
| SECONDARY Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers |
1135.8; 1275.5; 1274.0; 340.4; 274.5; 1004.1 | — |
| SECONDARY Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker |
659.9; 767.8; 718.9; 235.5; 176.8; 541.9 | — |
| SECONDARY Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker |
1056.2; 1164.7; 1168.3; 291.7; 243.9; 943.0 | — |
| SECONDARY Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker |
673.7; 736.2; 736.7; 193.2; 136.0; 567.9 | — |
| SECONDARY Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker |
969.0; 1057.2; 1062.8; 267.5; 221.0; 935.2 | — |
| SECONDARY Anti-gE Specific Antibody Concentrations |
3384.8; 4280.3; 5258.2; 1664.5; 1888.2; 2363.8 | — |
| SECONDARY Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations |
4190.1; 4761.3; 5559.1; 2704.1; 2733.8; 2557.4 | — |
| SECONDARY Frequency of VZV-specific Memory B-cells in a Subset of Subjects |
336.5; 490.4; 356.6; 332.3; 380.6; 5699.3 | — |
| SECONDARY Number of Subjects With Different Biochemical and Haematological Levels |
0; 0; 0; 0; 0; 13 | — |
| SECONDARY Number of German Subjects With Different Biochemical and Haematological Levels |
4; 6; 8; 6; 2; 1 | — |
| SECONDARY Number of German Subjects With Different Biochemical and Haematological Levels |
4; 6; 8; 6; 2; 1 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
94; 11; 99; 2; 7; 0 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
36; 48; 46; 20; 8; 1 | — |
| SECONDARY Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes |
1; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
55; 52; 54; 41; 16; 7 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
11; 14; 11; 16; 3; 21 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
11; 14; 11; 16; 3; 21 | — |
Summary
Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 & 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.
No new subjects will be enrolled during the extension phases of the study.
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female aged 60 years or older at the time of the first vaccination.
- Written informed consent obtained from the subject
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed.
- Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection.
- Previous vaccination against HZ.
- History of herpes zoster (Shingles).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject's medical history or physical examination as assessed by the investigator.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period.
- History of or current drug and/or alcohol abuse.
Data sourced from ClinicalTrials.gov (NCT00434577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.