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Herpes Zoster clinical trials

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NCT ID: NCT01506661 Completed - Clinical trials for Rheumatoid Arthritis

Safety of Zostavax Vaccination in Rheumatoid Arthritis

Start date: January 2012
Phase: Phase 1
Study type: Interventional

Herpes Zoster (shingles) is caused by reactivation of latent varicella zoster virus (VZV) that usually occurs decades following initial exposure. The risk of developing shingles increases with age. Shingles presents as a painful, itchy blistering rash that usually involves a single portion of the skin and lasts about 7-10 days. The risk of developing shingles increases with age in healthy people, and has been shown in some studies to be increased in people with rheumatoid arthritis and other autoimmune diseases. Zostavax, a live-attenuated vaccine against the varicella zoster virus, was first approved by the FDA for the prevention of Shingles among people 60 years and older, and is now approved for use in people aged 50 years and older. Because rheumatoid arthritis and some of the medications used to treat rheumatoid arthritis can impair the body's immune system, it is not known how much of an immune response can be generated in people with rheumatoid arthritis. The goals of this study are to measure the immune response after standard vaccination with Zostavax in people with rheumatoid arthritis in comparison to people with healthy immune systems. All participants will be 50 years old or older, and subjects with rheumatoid arthritis will not be eligible if they are taking certain biologic medications, including TNF inhibitors (Etanercept or Adalimumab). Ten healthy subjects and 10 subjects with rheumatoid arthritis will all receive a single vaccination with Zostavax, then will be followed for 12 weeks to assess the immune response and for the development of local rash or other potential side effects.

NCT ID: NCT01506193 Completed - Measles Clinical Trials

Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children

Start date: February 6, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136, PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.

NCT ID: NCT01505647 Completed - Herpes Zoster Clinical Trials

Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)

Start date: April 2012
Phase: Phase 3
Study type: Interventional

This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.

NCT ID: NCT01483378 Completed - Herpes Zoster Clinical Trials

Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital

Start date: January 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if vaccination rate of eligible patients at a major urban public hospital will increase by having ophthalmologists screen patients for eligibility and a nurse administer the vaccine in the General Eye Clinic.

NCT ID: NCT01460719 Completed - Herpes Zoster Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With Hematologic Malignancies (HM) Receiving Treatment With Anti-Cluster of Differentiation (CD) 20 Monoclonal Antibodies (V212-013)

Start date: January 24, 2012
Phase: Phase 1
Study type: Interventional

An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated VZV vaccine (V212) in participants with hematologic malignancies (HM) who are currently receiving anti-CD20 monoclonal antibodies. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at ~28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the geometric mean fold rise in immune response in V212 recipients is >1.0.

NCT ID: NCT01391546 Completed - Herpes Zoster Clinical Trials

Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)

Start date: June 20, 2011
Phase: Phase 3
Study type: Interventional

PRIMARY OBJECTIVES Two co-primary objectives are: - To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC) - To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of varicella zoster virus (VZV) antibody titre from pre to 4-week post-vaccination SECONDARY OBJECTIVES Immunogenicity objectives - To evaluate the immunogenicity as measured by VZV antibody titre at 4 weeks following ZOSTAVAX administered by IM or SC route - To evaluate the immune response as measured by a second assay, the VZV Interferon gamma Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or SC route Safety objective - To describe the safety profile of ZOSTAVAX administered by IM or SC route

NCT ID: NCT01385566 Completed - Herpes Zoster Clinical Trials

A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)

Start date: September 2011
Phase: Phase 1
Study type: Interventional

This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.

NCT ID: NCT01331161 Completed - Shingles Clinical Trials

Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly

Start date: July 2011
Phase: N/A
Study type: Interventional

Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population. In this trial, the investigators will study the immunologic differences of the FDA approved licensed shingles vaccine between a younger and an older group. Thirty three healthy volunteers between the ages of 25-40 and forty four healthy volunteers between the ages of 60-79 will be enrolled in the study. Each participant in the study will be given one shingles shot. Blood work will be obtained one month before vaccination, on the day of vaccination, one day, three days, seven days, fourteen days, one month, three months and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.

NCT ID: NCT01327144 Completed - Herpes Zoster Clinical Trials

Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster

Start date: June 2012
Phase: Phase 3
Study type: Interventional

Herpes Zoster is an infection that affects part of the nervous system caused by Varicella Zoster Virus. Herpes Zoster manifests as vesicular eruption in the dermatome, often associated with significant pain. There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms as famciclovir and aciclovir. This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with Famciclovir (500 mg) comparing to Aciclovir (400 mg) in patients with Herpes Zoster.

NCT ID: NCT01295320 Completed - Herpes Zoster Clinical Trials

Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects

Start date: February 28, 2011
Phase: Phase 2
Study type: Interventional

The 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.