Overview

This trial is active, not recruiting.

Condition herpes zoster
Treatments herpes zoster vaccine (gsk 1437173a), placebo
Phase phase 3
Sponsor GlaxoSmithKline
Start date March 2013
End date January 2016
Trial size 568 participants
Trial identifier NCT01767467, 116428, 2012-003438-18

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Subjects will receive the candidate HZ vaccine (GSK 1437173A).
herpes zoster vaccine (gsk 1437173a)
2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.
(Placebo Comparator)
Subjects will receive the placebo vaccine.
placebo
2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.

Primary Outcomes

Measure
Occurrence of solicited local and general symptoms
time frame: Up to 7 days (Days 0-6) after each vaccination
Occurrence of unsolicited adverse events (AEs)
time frame: Up to 30 days (Days 0-29) after each vaccination
Occurrence of serious adverse events (SAEs)
time frame: Up to 30 days post last vaccination
Occurrence of AEs of specific interest
time frame: Up to 30 days post last vaccination
Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia
time frame: At Month 2

Secondary Outcomes

Measure
Occurrence of serious adverse events (SAEs)
time frame: From first vaccination up to 6 months post last vaccination
Occurrence of SAEs
time frame: From 30 days post last vaccination until study end
Occurrence of AEs of specific interest
time frame: From first vaccination up to 6 months post last vaccination
Occurrence of AEs of specific interest
time frame: From 30 days post last vaccination until study end
Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma
time frame: At Month 2
Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia
time frame: At Month 2
Occurrence of confirmed HZ cases
time frame: From Month 0 until study end
Anti-gE humoral immunogenicity in all vaccinated subjects
time frame: At Month 0, Month 1, Month 2 and Month 13
Anti-gE humoral immunogenicity in all vaccinated subjects
time frame: At Month 1, Month 2 and Month 13
gE-specific CD4+ T-cell-mediated immunogenicity response in the CMI sub-cohort
time frame: At Month 0, Month 1, Month 2 and Month 13
gE-specific CD4+ T-cell-mediated immunogenicity response in the CMI sub-cohort
time frame: At Month 1, Month 2 and Month 13
Anti-gE humoral immunogenicity in subjects with confirmed HZ and matched controls
time frame: At Month 0 and at Month 2

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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
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).
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.