Clinical trial NCT01767467: Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers
Official title: Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Keywords: Immunogenicity
Safety
Herpes zoster
Vaccination
Haematologic malignancies
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-01-14
Enrollment: 568
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 safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.

Detailed description: Amendment to protocol posting:

Increase in sample size, update of country/region-specific information (Sections 5, 6 and 9).

Promotion of secondary to primary objective; related update of primary and secondary outcome measures (Sections 4 and 7).

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes 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 at the time of study entry.
* Subject who has been diagnosed with one or more haematologic malignancies prior to the first vaccination and who is receiving, is scheduled to receive or has just finished immunosuppressive cancer therapy to treat this condition.
* Life expectancy greater than or equal to 12 months, as assessed by the investigator.
* 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 inthe 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:

* Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intra-venous cancer therapy in combination with oral therapy may be enrolled).
* Subject receiving radiotherapy alone as treatment for his/her haematologic malignancy.
* Planned haematopoietic stem cell transplant (HCT) during the study period. (If a HCT occurred prior to enrolment in the study, the subject may not receive study vaccine until at least 50 days after the transplant procedure).
* Human immunodeficiency virus (HIV) infection by clinical history.
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subject's underlying disease, is allowed.
* Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
* Planned administration during the study of a HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
* Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* 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.
* Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 3 (i.e., 2 months after the last dose of study vaccine/placebo).

Primary outcomes:
measure: Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations
timeFrame: At Month 2
measure: Adjusted Geometric Mean Concentration of Anti-gE Antibodies
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: Within the 7-day (Days 0-6) post-vaccination period
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: Withing the 7-day (Day 0-6) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: Within the 30-day (Days 0-29) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From first vaccination up to 30 days post last vaccination
measure: Number of Subjects Reporting Any and Related Potential Immune-mediated Diseases (pIMDs)
timeFrame: From first vaccination up to 30 days post last vaccination
Secondary outcomes:
measure: Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
timeFrame: At Month 2
measure: Anti-gE Antibody Concentrations
timeFrame: At Month 2
measure: Time to Occurrence of Any Confirmed HZ Case
timeFrame: From Month 0 until study end (Month 13)
measure: Anti-gE Antibody Concentrations
timeFrame: At Months 0, 1, 2 and 13
measure: Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
timeFrame: At Months 1, 2 and 13
measure: Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers
timeFrame: At Months 0, 1, 2 and 13
measure: Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers
timeFrame: At Months 1, 2 and 13
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From first vaccination at Month 0 up to study end at Month 13
measure: Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
timeFrame: From first vaccination at Month 0 up to study end at Month 13
measure: Geometric Mean Concentrations (GMCs) of Anti-gE Antibodies
timeFrame: At Months 0 and 2
measure: Mean Geometric Increase (MGI) of Anti-gE Antibody ELISA Concentrations
timeFrame: At Month 2
Other outcomes:
Locations:
city: Inverness
country: United States
facility: GSK Investigational Site
state: Florida
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Elkhart
country: United States
facility: GSK Investigational Site
state: Indiana
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Marshfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Darlinghurst
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Hobart
country: Australia
facility: GSK Investigational Site
state: Tasmania
city: Coburg
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Wodonga
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Antwerpen
country: Belgium
facility: GSK Investigational Site
city: Brugge
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Hasselt
country: Belgium
facility: GSK Investigational Site
city: Jette
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Saint John
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Oshawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Praha 2
country: Czechia
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Montpellier cedex 5
country: France
facility: GSK Investigational Site
city: Mulhouse
country: France
facility: GSK Investigational Site
city: Nantes cedex 1
country: France
facility: GSK Investigational Site
city: Pessac cedex
country: France
facility: GSK Investigational Site
city: Périgueux cedex
country: France
facility: GSK Investigational Site
city: Rouen cedex 1
country: France
facility: GSK Investigational Site
city: Hong Kong
country: Hong Kong
facility: GSK Investigational Site
city: Meldola (FC)
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Udine
country: Italy
facility: GSK Investigational Site
state: Friuli-Venezia-Giulia
city: Novara
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Jellanamdo
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeonju
country: Korea, Republic of
facility: GSK Investigational Site
city: Kyunggi-do
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: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Hamilton
country: New Zealand
facility: GSK Investigational Site
city: Lahore
country: Pakistan
facility: GSK Investigational Site
city: Multan
country: Pakistan
facility: GSK Investigational Site
city: Panama
country: Panama
facility: GSK Investigational Site
city: Chorzow
country: Poland
facility: GSK Investigational Site
city: Opole
country: Poland
facility: GSK Investigational Site
city: Slupsk
country: Poland
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Petrozavodsk
country: Russian Federation
facility: GSK Investigational Site
city: St'Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Móstoles
country: Spain
facility: GSK Investigational Site
state: Madrid
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: Pozuelo De Alarcón/Madrid
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Eskilstuna
country: Sweden
facility: GSK Investigational Site
city: Karlskrona
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan Hsien
country: Taiwan
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Orpington
country: United Kingdom
facility: GSK Investigational Site
state: Kent
city: Airdrie
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Swindon
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Bournemouth
country: United Kingdom
facility: GSK Investigational Site
city: Headington, Oxford
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Dagnew AF, Ilhan O, Lee WS, Woszczyk D, Kwak JY, Bowcock S, Sohn SK, Rodriguez Macias G, Chiou TJ, Quiel D, Aoun M, Navarro Matilla MB, de la Serna J, Milliken S, Murphy J, McNeil SA, Salaun B, Di Paolo E, Campora L, Lopez-Fauqued M, El Idrissi M, Schuind A, Heineman TC, Van den Steen P, Oostvogels L; Zoster-039 study group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. Lancet Infect Dis. 2019 Sep;19(9):988-1000. doi: 10.1016/S1473-3099(19)30163-X. Epub 2019 Aug 6.