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GSK 1437173A

Phase 3

Herpes Zoster | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 13, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment237
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01798056Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving ChemotherapyPHASE3 COMPLETED 237Mar 6, 2013May 20, 2016May 13, 202128 Canada, Czechia +4
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Study Endpoints
Primary Endpoints
Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups
At Month 2

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

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

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.

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
During 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 = 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.

Number of Days With Solicited Local Symptoms
During the 7-day (Days 0-6) post-vaccination period following each dose

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

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
During 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 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.

Number of Days With Solicited General Symptoms
During the 7-day (Days 0-6) post-vaccination period following each dose

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

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
During the 30-day (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 investigator as related to the vaccination.

Number of Subjects With Serious Adverse Events (SAEs)
From first dose up to 30 days post last vaccination

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.

Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
From first vaccination up to 30 days post last vaccination

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.

Secondary Endpoints
Anti-VZV gE Antibody Concentrations
At Months 0, 1, 6 and 13
Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations
At Months 1, 2, 6 and 13
Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups
At Months 0, 1, 2 and 13
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
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.
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.
Interventions
NameTypeDescription
GSK 1437173ABIOLOGICAL2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.
PlaceboDRUG2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * 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...

Countries:CanadaCzechiaFranceSouth KoreaSpainUnited Kingdom
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