86 Clinical Trials for Various Conditions
The study consists of two arms (PHARM and PEER) designed to educate participants about three vaccine-preventable diseases (zoster, pneumonia, and influenza) and vaccination. PHARM will consist of a 60-minute presentation about the three vaccine-preventable diseases and their vaccinations delivered by a pharmacist, featuring a didactic lecture and discussion supplemented by video clips of community members discussing their experiences around vaccination, as well as physicians underscoring the importance of vaccination. PEER will consist of a 60-minute small-group session led by a peer educator which includes scripted roleplaying exercises designed to reinforce learnings pertaining to these three vaccine-preventable diseases and their vaccinations. The components of these interventions will be designed to address specific barriers to vaccination identified by literature search and our prior work in the area of community-based vaccine education. Both arms will focus primarily on pneumococcal disease and zoster but will include limited content on influenza because participants are likely to have questions about how the flu and its vaccination differ from pneumococcal diseases and zoster. The study will be implemented in an older, predominantly African-American (AA) population, consistent with our prior work in this area.
Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.
The purpose of this observational research study is to study if patients with herpes zoster, also known as Shingles, have a higher risk of vascular dysfunction (problems with blood vessels, including stroke) and vascular dementia (problems with mental decline as a result of decreased blood flow to the brain) compared to patients without herpes zoster. Patients are evaluated based on the group they are assigned too: 1. Herpes Zoster (HZ) Group: individuals presenting with untreated herpes zoster. These participants will have 6 visits: * Day 1 = 1st day presenting to clinic with acute zoster * 7 days post zoster * 1 month after Day 1 * 3 months after Day 1 * 6 months after Day 1 * 12 months after Day 1 2. Control Group: individuals without herpes zoster o Day 1 (only 1 visit will be completed) This study does not have a study medication/device. Standard of care for all patients will be followed.
The goal of this clinical trial is to assess the safety and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles). Subjects will be randomized to receive either JCXH-105 or Shingrix.
The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 69 years of age
The goal of this clinical trial is to assess the safety and immunogenicity of a self-replicating (sr) RNA-based vaccine, JCXH-105, in the prevention of Shingles (Herpes Zoster) Participant will be randomized to receive either JCXH-105 or Shingrix.
This clinical trial is to study the safety and tolerability of a recombinant herpes zoster vaccine (LZ901) and sponsored by Beijing Luzhu Biotechnology Co., Ltd. It is a phase I, randomized, double-blind, placebo-controlled, dose escalation study in healthy people aged 50 to 70 years inclusive. The study is to protect adults against shingles (herpes zoster / varicella zoster virus(VZV)). There will be about 66 participators who will receive two-dose injection at the upper arm. LZ901 vaccine is made up of a tetramer of VZV glycoprotein E (VZV gE-Fc) and adsorbed with aluminum hydroxide adjuvant. This adjuvant can raise the immune response to a lot of antigens. It is the most widely used and safe adjuvant in various types of vaccines worldwide. In this study: 1. The participation is voluntary. 2. Before the study, participants will receive some tests for screening. If qualified, investigators will officially invite them to join this study. 3. The study vaccine is LZ901 with two different dose levels (50μg/0.5 mL, 100μg/0.5 mL). The placebo, which is saline solution, has no active drug. Participants will receive one of three as above mentioned. 4. Participants will be enrolled in one of four cohorts. If participants are enrolled in Cohorts 1 or 2, they will receive LZ901. If participants are enrolled in Cohorts 3 or 4, they will have a 2 out of 3 chance (66%) of receiving LZ901 and 1 out of 3 chance (33%) of receiving placebo. 5. In Cohort 3 and 4, the study staff and participants will not know which study treatment participants will be receiving. However, the study doctor can get this information in case of an emergency. 6. Participants will stay at the clinic for 30 minutes after each vaccination to observe if there are any uncomfortable. 7. This study will last about 8 months and will include about 8 study visits to the clinic. During this period, participants will receive a follow-up phone call and/or email by the study staff to follow the condition closely for safety, and record on diary/contact card. 8. Participants will receive some tests during the study, include safety tests such as physical examination, vital signs measurements, blood tests, urinalysis. Participants will be measured the levels of specific antibodies to see if the vaccine works well. This study is for research purposes only. Participants may not receive any direct benefits from participating in this study but have a chance to be in a study that may help others in the future.
This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to placebo with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment. In addition, the investigators hypothesize that immunogenicity of the vaccine in SLE patients will be at least 50% of levels observed in healthy subjects from prior large clinical trials.
The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary vaccination in ZOSTER-006/022 studies), persistence of immunogenicity and safety of GSK's Herpes Zoster subunit (HZ/su) vaccine in older adults. The persistence of immunogenicity and safety of 1 or 2 additional doses (0, 2-month schedule) of HZ/su vaccine administered to a small group of participants in ZOSTER-049 study (approximately 5 years after the initial vaccination in ZOSTER-006/022 studies) will also be assessed.
The purpose of this study is to assess the safety and immunogenicity of CRV-101, an investigational vaccine compared to Shingrix for the prevention of herpes zoster in adults aged 50 years and older
Inflammatory bowel disease (IBD) is a chronic inflammatory state of the gastrointestinal tract affecting 1.6-3.1 million people in the United States. Patients with IBD are treated with immunosuppressants that increase their risk of herpes zoster (HZ), also known as shingles. Those with IBD have a two-fold increased risk for HZ compared to age matched controls. Because most IBD patients are treated with systemic immunosuppressants, which are an independent risk factor for HZ, the live attenuated HZ vaccine was not recommended. However, the release of the new inactivated HZ vaccine, Shingrix (GlaxoSmithKline), presents new opportunities for preventive care.
Inflammatory bowel disease (IBD) patients under the age of 50 can have a greater risk than the general population above age 50. IBD patient are commonly treated with immunosuppression that increases the risk for Herpes Zoster. A new HZ vaccine is available that could decrease the risk of HZ in IBD patients.
The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.
The purpose of this study is to evaluate the impact of reactogenicity of GSK Biologicals' HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age
The purpose of this study was a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and included an assessment of 1 or 2 additional doses in two subgroups of older adults.
The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects \>= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5 years earlier.
The purpose of this study is to evaluate the efficiency of topical gancyclovir 0.15% in the treatment of herpes zoster keratitis. Half the patients will receive the study drug while the other half of the patients will receive the placebo
This study will compare the two vaccines that have been developed to prevent and/or lessen the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other, herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an ingredient that may enhance the body's immune response to the vaccine, and is currently investigational. The vaccines are being compared to assess their ability to stimulated protection against shingles. The study will provide an opportunity to determine the safety profile of each vaccine in a single trial. The study will also look at the effect of age on the immune response to the two vaccines and on the persistence of these responses.
The purpose of this study is to demonstrate lot-to-lot consistency in terms of immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study is designed as a randomized, double-blind study with three parallel groups.
The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately.
The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax 23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on Pneumovax 23™ vaccine immune response will also be evaluated.
The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine in adults aged 50 years or older compared to administration of vaccines separately.
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.
The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.
The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.
Despite the significant benefits of herpes zoster vaccine (HZV), vaccination rates remain low. Electronic medical records (EMR) can serve as a practical strategy to better facilitate the application of preventative health care, such as increasing immunization rates. A new care model that can increase the herpes zoster vaccination rate, as well as other preventative health services, is warranted. The objective of this study is to investigate if the functions of an EMR, in combination with a pharmacist as part of the care team, can improve the herpes zoster vaccination rate.
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.
The addition of gabapentin therapy to standard antiviral treatment with valacyclovir in acute herpes zoster patients will decrease the incidence of post-herpetic neuralgia.
The 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.