Vaccination against HZ in adults with haematologic malignancies. MedDRA version: 17.0 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion 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; For this study population, non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause OR 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 414 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 138
Exclusion criteria
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.); - HIV infection by clinical history; - Use of any investigational or non-registered product (drug or vaccine) 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 (* inactivated and subunit vaccines, including inactivated and subunit influenza vaccines and pneumococcal conjugate vaccines): - 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the safety and reactogenicity following administration of the HZ/su vaccine compared to placebo from the first vaccination up to 30 days post last vaccination in subjects with haematologic malignancies, aged 18 years and older. - To evaluate vaccine response rate for anti-gE humoral immune responses at Month 2 following a two-dose administration of the HZ/su vaccine in subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma (NHBCL) and Chronic Lymphocytic Leukaemia (CLL). - To evaluate anti-gE humoral immune responses at Month 2 following a two-dose administration of the HZ/su vaccine, as compared to placebo, in subjects with haematologic malignancies excluding subjects with NHBCL and CLL. ;Secondary Objective: In subjects with haematologic malignancies aged 18 years and older: - Evaluate safety following administration of HZ/su vaccine compared to placebo: from 1st vaccination up to 6 months post vaccination in at least 50% of the total vaccinated cohort, and, from 30 days post vaccination until study end. - Evaluate anti-gE humoral immune responses at Month 2 following two doses of the HZ/su vaccine: compared to placebo, excluding subjects with NHBCL; and VRR, excluding subjects with NHBCL. - Evaluate incidence of confirmed HZ cases. - Characterize anti-gE humoral immune responses at Month 0, 1, 2 and 13 within HZ/su and placebo groups by underlying disease strata. - Characterize gE-specific CD4+ T-cell mediated immune responses at Month 0, 1, 2 and 13 within HZ/su and placebo groups in the CMI sub-cohort and by underlying disease strata. - Assess correlation of HZ/su vaccine-induced humoral immune responses with protection against HZ.;Primary end point(s): * Occurrence of solicited local and general symptoms. - Occurrence, intensity and duration of each solicited local symptom in all subjects. - Occurrence, intensity, duration and relationship to vaccination of each solicited general symptom in al | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: SAEs and AEs of specific interest: 1. From first vaccination up to 6 months post last vaccination, 2. From 30 days post last vaccination until study end Anti-gE humoral immunogenicity excluding subjects with Non-Hodgkin b-cell Lymphoma: At Month 2 HZ cases: From Month 0 until study end Anti-gE humoral immunogenicity in all vaccinated subjects and CMI in the CMI sub-cohort: 1. At Month 0, Month 1, Month 2 and Month 13, 2. At Month 1, Month 2 and Month 13 Anti-gE humoral immunogenicity in subjects with confirmed HZ cases and matched controls: At Month 0 and at Month 2;Secondary end point(s): * Occurrence of SAEs 1. Occurrence and relationship to vaccination of all SAEs in at least 50% of the total vaccinated cohort. 2. Occurrence and relationship to vaccination of all SAEs in all subjects. * Occurrence of AEs of specific interest. 1. Occurrence of any pIMDs in at least 50% of the total vaccinated cohort. 2. Occurrence of any pIMDs in all subjects. * Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma. - Vaccine response for anti-gE humoral immunogenicity, as determined by ELISA. - Anti-gE antibody concentrations, as determined by ELISA. * Occurrence of confirmed HZ cases * Anti-gE humoral immunogenicity in all vaccinated subjects. 1. Anti-gE antibody concentrations, as determined by ELISA. 2. Vaccine response for anti-gE humoral immunogenicity, as determined by ELISA. * gE-specific CD4+ T-cell-mediated immunogenicity response in the CMI sub-cohort. 1. Frequencies of gE-specific CD4+ T-cells, expressing at least 2 activation markers (from among IFN-?, IL-2, TNF-a and CD40L), as determined by in vitro intracellular cytokine staining (ICS). 2. Vaccine response for gE-specific CD4+ T-cells expressing at least 2 activation markers (from among IFN-?, IL-2, TNF-a and CD40L), as determined by in vitro ICS * Anti-gE humoral immunogenicity in subject | — |
Countries
Australia, Belgium, Canada, Czech Republic, Finland, France, Hong Kong, Italy, Korea, Republic of, New Zealand, Pakistan, Panama, Poland, Russian Federation, Singapore, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed