
Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus...
Herpes ZosterThis observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, firstly enrolling subjects treated with antiretroviral therapy (ART) and with high CD4 T cell counts, and subsequently ART-treated subjects with low CD4 T cell counts, and ART-naïve subjects with high CD4 T cell counts. This Protocol Posting has been updated following Amendment 1 of the Protocol, August 2010. The impacted sections is exclusion criteria.

Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes...
Herpes ZosterHerpes Zoster VaccineThe purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years. Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.

The Immunogenicity of Varicella-zoster Virus Vaccine in HIV-infected Children
HIV InfectionsVaricella-zoster VirusTo study about the immunogenicity, safety and efficacy of varicella-zoster virus vaccine in HIV-infected children.

Live Zoster Vaccine in HIV-Infected Adults on Antiretroviral Therapy
Herpes ZosterHIV InfectionsHerpes zoster, or shingles, is the result of a viral infection that causes a painful skin rash, usually in older people or people with suppressed immune systems like those infected with HIV. The ZOSTAVAX vaccine has been shown to reduce the number of infections and symptoms of herpes zoster infection in people over the age of 60. The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two doses of ZOSTAVAX in HIV-1-infected adults with conserved immune function (Cd4+ T cell counts >=200 cells/uL) virologically suppressed on potent combination antiretroviral therapy (ART).

Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects...
Herpes ZosterThe subjects included in this study are subjects that participated in study NCT00434577. These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for safety and immunogenicity. This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72. The study visits will be scheduled at approximately one year intervals after the first visit in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. Information on safety and the occurrence of HZ will also be collected during these visits.

A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
Herpes ZosterThis study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.

A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
Meningococcal MeningitisMeasles3 moreThis is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age. Primary Objective: To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135. Secondary Objectives: Immunogenicity To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines. To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with PCV vaccine. Safety - To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events (SAEs) throughout the course of the study.

Safety, Tolerability, and Immunogenicity of CRV-101 in Healthy Adult Subjects
Herpes ZosterVaricella ZosterThe purpose of this clinical trial is to evaluate the safety, tolerability, and immunogenicity of vaccine candidate CRV-101, investigational vaccine in healthy adult subjects in the United States.

Subunit Vaccine Against Herpes Zoster in RA Patients Treated With JAK-inhibitors (VACCIMIL-ZOSTER)...
Rheumatoid ArthritisHealthy ControlsBackground. A new subunit vaccine against herpes zoster (HZ) has recently been approved for vaccination of adults i in Sweden. This vaccine (Shingrix) elicits a strong cellular and humoral immune response in healthy adults regardless of age. Studies on the immunogenicity and efficacy of this vaccine in immunosuppressed patients, such as patients with rheumatoid arthritis (RA), are scarce. Objectives. To investigate: 1) the immunogenicity of subunit vaccine against HZ in patients with RA treated with janus kinase (JAK)-inhibitors compared to healthy controls; 2) the tolerability of subunit vaccine against HZ 3) long-term immunogenicity of two doses of subunit HZ vaccine 4) the impact of smoking habits and alcohol consumption on the immunogenicity of vaccine and protection against HZ 5) the efficacy of this vaccine. Methodology. Patients with RA, regularly followed at the Skåne University Hospital, section for rheumatology in southern Sweden are eligible for the study and will be offered vaccination. Blood samples will be collected immediately before the first vaccine dose and 4-6 weeks after the second dose and thereafter 3 and 5 years after the second vaccination. The levels of antibodies to glycoprotein E (gE) will be measured with standard ELISA on the blood samples collected at vaccination, 4-6 weeks following the second vaccination and after 3 and 5 years. A flow-cytometric assay will be used for the detection of the cell-mediated immunity (number of antigen specific CD4+ T-cells) against the varicella-zoster virus. The prevalence of HZ among patients participating in the study will be compared to in-patient and out-patient registry data on the corresponding infections among age- and sex- matched non-vaccinated controls using data from the regional health and care registry in southern Sweden.

Placebo Controlled Evaluation of the Cell Mediated Immune Response of Cirrhotic Subjects to Zostavax™...
Herpes ZosterFibrosisStudy Design: Double-blinded, placebo controlled study of the efficacy of Zostavax in cirrhosis. Subjects will receive either Zostavax or placebo and will be followed for four months. Hypothesis: The investigators hypothesize Zostavax would induce cell-based immunity in cirrhotic patients like that seen in elderly patients.