Clinical trial NCT01798056: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Herpes Zoster Vaccine
Keywords: ≥18 years of age
Chemotherapy
Solid tumours
Immunogenicity
Herpes Zoster
Safety
Shingles
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-02-25
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.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.
* 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.

Exclusion Criteria:

* 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.
* 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).

Primary outcomes:
measure: Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups
timeFrame: At Month 2
measure: Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations
timeFrame: At Month 2
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Days With Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Days With Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day (Days 0-29) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From first dose up to 30 days post last vaccination
measure: Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
timeFrame: From first vaccination up to 30 days post last vaccination
Secondary outcomes:
measure: Anti-VZV gE Antibody Concentrations
timeFrame: At Months 0, 1, 6 and 13
measure: Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations
timeFrame: At Months 1, 2, 6 and 13
measure: Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups
timeFrame: At Months 0, 1, 2 and 13
measure: Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups
timeFrame: At Months 1, 2 and 13
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From 30 days post last vaccination up to study end (Month 13)
measure: Number of Subjects With Any Potential Immune Mediated Diseases (pIMDs)
timeFrame: From 30 days post last vaccination up to study end (Month 13)
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Praha 8
country: Czechia
facility: GSK Investigational Site
city: Besançon cedex
country: France
facility: GSK Investigational Site
city: Ferolles-Attilly
country: France
facility: GSK Investigational Site
city: Lyon Cedex 08
country: France
facility: GSK Investigational Site
city: Nîmes cedex 9
country: France
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Badajoz
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Majadahonda (Madrid)
country: Spain
facility: GSK Investigational Site
city: Móstoles
country: Spain
facility: GSK Investigational Site
city: Pozuelo De Alarcón/Madrid
country: Spain
facility: GSK Investigational Site
city: San Sebastian de los Reyes
country: Spain
facility: GSK Investigational Site
city: Cheltenham
country: United Kingdom
facility: GSK Investigational Site
state: Gloucestershire
city: Woolwich
country: United Kingdom
facility: GSK Investigational Site
state: London
city: Swindon
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Exeter
country: United Kingdom
facility: GSK Investigational Site
city: Sheffield
country: United Kingdom
facility: GSK Investigational Site
city: York
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.