Clinical trial NCT00802464: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years
Official title: Immunogenicity and Safety Study of Different Formulations of GSK Biologicals' Herpes Zoster Vaccine 1437173A When Administered Twice in Adults Aged 50 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Zoster
Keywords: Cytokine
Vaccine
Herpes Zoster (HZ)
Cell mediated immunity (CMI)
Antibody response
Varicella Zoster Virus (VZV)
Shingles
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 410
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.


Eligibility criteria: Inclusion Criteria:

* A male or female 50 years of age or above at the time of the first vaccination;
* Written informed consent obtained from the subject;
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
* If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
* Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;
* Previous vaccination against HZ;
* Previous vaccination against varicella;
* History of HZ;
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period;
* Acute disease at the time of enrolment.
* Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
* History of or current drug and/or alcohol abuse;
* Pregnant or lactating female;
* Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.

Primary outcomes:
measure: Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers
timeFrame: One month after the second vaccination (Month 3)
measure: Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
timeFrame: One month after the second vaccination (Month 3)
measure: Anti-glycoprotein E (gE) Antibody Concentrations
timeFrame: One month after the second vaccination (Month 3)
measure: Anti-VZV Antibody Concentrations
timeFrame: One month after the second vaccination (Month 3)
Secondary outcomes:
measure: Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
timeFrame: At Month 0 and at Month 2
measure: Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
timeFrame: At Month 0 and at Month 2
measure: Anti-gE Antibody Concentrations
timeFrame: At Month 0 and at Month 2
measure: Anti-VZV Antibody Concentrations
timeFrame: At Month 0 and 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 after each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 7-day (Days 0-6)post-vaccination period after each dose and across doses
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 Month 0 up to Month 8
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the period after Month 8 up to the end of the study at Month 14
measure: Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)
timeFrame: From Month 0 until Month 8
measure: Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)
timeFrame: During the period after Month 8 up to the end of the study at Month 14
measure: Number of Subjects With Suspected Cases of Herpes Zoster (HZ)
timeFrame: From Month 0 until Month 8
measure: Number of Subjects With Suspected Cases of Herpes Zoster (HZ)
timeFrame: During the period after Month 8 up to the end of the study at Month 14
measure: Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
timeFrame: At Month 0
measure: Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
timeFrame: At Month 2
measure: Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
timeFrame: At Month 3
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Edison
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Mahadahonda( Madrid
country: Spain
facility: GSK Investigational Site
city: Marid
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Chlibek R, Bayas JM, Collins H, de la Pinta ML, Ledent E, Mols JF, Heineman TC. Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age. J Infect Dis. 2013 Dec 15;208(12):1953-61. doi: 10.1093/infdis/jit365. Epub 2013 Jul 31.