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Herpes Zoster clinical trials

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NCT ID: NCT06344403 Recruiting - Acute Pain Clinical Trials

Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Acute and Subacute Zoster Associated Pain

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Herpes zoster (HZ) is a skin infection disease which cause severe zoster-associated pain (ZAP) along sensory nerve in the corresponding segment. Evidence for the efficacy of existing local therapies for acute/subacute ZAP is limited. The hypothesis is that patients with acute/subacute ZAP treated with TPIs with local anesthetic and steroids under the basis of standard treatment will show better clinical outcomes compared with subjects treated with standard antiviral medicine treatment only.

NCT ID: NCT06334861 Recruiting - Herpes Zoster Clinical Trials

Multidisciplinary Hospital-Territory Vaccine Center: a Model for Achieving the Herpes Zoster Vaccine Coverage

CeVOT-Her-Zo
Start date: June 23, 2022
Phase:
Study type: Observational

The National Vaccination Program, updated by the Ministry of Health in 2021, provides a new vaccination opportunity for frail patients against Herpes zoster virus (HZ). The new treatment option, on the other hand, is designed by combining VZV-specific antigen (gE) with an adjuvant system (AS01B) to induce antigen-specific cellular and humoral immune responses in individuals with preexisting immunity to VZV. Efficacy, assessed in people given two doses 2 months apart, is around 97% in those aged 50 years and 91% in those over 70 years. In the studies conducted, HZ-related hospitalizations were significantly reduced. The vaccine schedule calls for the administration of two doses 2 months apart. The current HZ Vaccination Program implemented at the regional level recommends its active and free offer in people from 18 years of age with congenital and/or acquired immunodepression, through a collaborative relationship involving, on the one hand, multispecialist and multiprofessional medical staff and, on the other hand, citizens called to play a role that is no longer passive but the subject of empowerment by consciously making their own health choices. The collaboration with ASL Roma1, in this sense, acquires value as guarantor of the supply of the adjuvanted recombinant anti-HZ vaccine and of the appropriate reporting of vaccination coverage, which to date is still far from the targets set by the PNPV'17-'19 in adults at risk for disease. The purpose of this study Single-center prospective longitudinal observational cohort study is to verify patients' compliance with the proposed vaccination, the effectiveness of counseling carried out by a multidisciplinary team in the hospital setting.

NCT ID: NCT06238726 Recruiting - Behavior, Health Clinical Trials

Nudging Patients to Increase Shingles Vaccination

Start date: March 25, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to test whether messages encouraging patients to ask about a Shingrix vaccine at an upcoming appointment will increase Shingrix vaccination rates. The study will also test which of several message versions is most effective.

NCT ID: NCT06137755 Recruiting - Herpes Zoster Clinical Trials

Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above

Start date: March 15, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-VZV-001.

NCT ID: NCT06088745 Recruiting - Herpes Zoster Clinical Trials

A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine

Start date: September 28, 2023
Phase: Phase 3
Study type: Interventional

This clinical trial is to study protective efficacy and safety of a recombinant herpes zoster vaccine (LZ901) and sponsored by Beijing Luzhu Biotechnology Co., Ltd. It is a phase Ⅲ, randomized, double-blind, placebo-controlled in healthy people aged 40 years and older. The study is to protect adults against shingles (herpes zoster / varicella zoster virus(VZV)). There will be about 26000 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.

NCT ID: NCT06001606 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Immunogenicity, Reactogenicity of Shingrix in SLE

Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial.

NCT ID: NCT05991427 Recruiting - Herpes Zoster Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of ChAdOx1-VZV in Healthy Adults Aged 50-65 Years

Start date: November 7, 2023
Phase: Phase 1
Study type: Interventional

This is a randomized, observer blind and controlled study. Participants in low-dose and high-dose IM group will be randomized in a ratio of 2:1 to receive either the investigational product or the control. Participants in the IH group will receive either inhaled investigational product or saline in a ratio of 3:1. Enrollment will be in an ascending order of dosage groups. All participants will receive 2 doses in 4 months interval. Blood samples will be collected for immunogenicity evaluation over the time course of the study.

NCT ID: NCT05952271 Recruiting - Herpes Zoster Clinical Trials

Herpes Zoster Hospitalizations in Italy

Start date: October 26, 2023
Phase:
Study type: Observational

In Italy, the 2017-2019 National Immunization Plan recommended specific vaccinations for the elderly, defined as those 65 years old and older, and at-risk adults with age 50+ (adults presenting cardiovascular, respiratory, or metabolic diseases, immunodepression, etc.). However, the coverage target set by the Plan (50% for Herpes Zoster vaccination in 2019) was not reached. Providing additional data on the incidence of Herpes Zoster could improve the risks perception of the disease and the vaccination uptake. The present study will aim to describe a full picture of Herpes Zoster associated hospital admissions in Italy, focusing on co-morbidities which induce reduced varicella-zoster virus-specific cell-mediated immunity response. Furthermore, as varicella-zoster virus reactivation was reported in COVID-19-positive patients, a deepening on a possible relationship between the two infections will be investigated.

NCT ID: NCT05898464 Recruiting - Clinical trials for Vaccine Adverse Reaction

Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV

Start date: June 27, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the immunogenicity and safety of recombinant zoster vaccine according to CD4+ T-cell count and age in people living with HIV, and to provide evidence to guide immunization of people living with HIV.

NCT ID: NCT05879419 Recruiting - Clinical trials for Rheumatoid Arthritis

Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases

RZVRheum
Start date: May 23, 2023
Phase: Phase 4
Study type: Interventional

Introduction: Patients with autoimmune rheumatic diseases (ARDs), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PAs), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), primary Sjögren's syndrome (pSS) , systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM) and primary vasculitides, have a high risk of herpes zoster (HZ) infection. This increased susceptibility is caused by a deficient cell-mediated immune response due to the underlying disease and glucocorticoid and immunosuppressive treatments that impair the T-cell response, including conventional and unconventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) and biological agents. In this context, the recent availability of a recombinant vaccine against HZ (RZV or Shingrix®), composed of recombinant VZV glycoprotein E (gE) and the AS01B adjuvant system (HZ/su), is a major progress regarding safety for immunosuppressed patients. Its effectiveness, however, has been clearly demonstrated for non-immunosuppressed patients and in selected populations of immunocompromised individuals. There are no prospective controlled studies evaluating the immunogenicity of RZV and its impact on the activity of the underlying disease, as well as its safety in patients with ARDs at high-risk for HZ. Hypothesis: RZV has a good safety profile, including with respect to underlying rheumatic disease activity, in patients with ARDs at high risk of HZ. Objectives: Primary: To assess the short-term safety profile in relation to underlying disease activity in patients with ARDs at high risk of HZ immunized with RZV compared to unvaccinated patients. Secondary: To evaluate the general safety of the vaccine in patients with ARDs at high risk of HZ immunized with RZV and non-immunosuppressed control subjects (CG); the humoral and cellular immunogenicity of RZV in patients with ARDs at high risk of HZ compared to CG; the influence of disease treatment on vaccine response; the 12-month persistence of humoral immunogenicity and incident cases of HZ. Specific studies will also be carried out to evaluate the effect of drug withdrawal (methotrexate-MTX and mycophenolate mofetil-MMF) after vaccination in increasing the immune response in patients with ARDs with controlled underlying disease.