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Herpes Zoster clinical trials

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NCT ID: NCT05924685 Completed - Immunosuppression Clinical Trials

PREPARE-iVAC Trial

PREPARE-iVAC
Start date: August 22, 2023
Phase: Phase 4
Study type: Interventional

Objective: To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior immunogenicity of COVID-19 vaccination as measured by neutralizing antibody titer against the Omicron XBB.1.5 strain. Trial design: Multicentre, open-label randomized controlled clinical trial, for a duration of at least 10 weeks with an optional extension to 18 weeks. Trial population: Kidney transplant recipients, 18 years or older, who are at least 6 months after transplantation, with a functioning kidney transplant, using MMF/MPA in combination with at least one other immunosuppressant including a calcineurin inhibitor (CNI), with at least 3 previous COVID-19 vaccinations (=basic COVID-19 immunisation). Interventions: Patients will be randomized into one of two equally sized groups, with either continuation of their current immunosuppressive regimen including MMF/MPA or replacement of MMF/MPA by everolimus during at least six weeks before until four weeks after the last vaccination. Patients will receive a repeated COVID-19 vaccination with the monovalent Omicron XBB.1.5 vaccine, 28 days thereafter they can opt to also receive two herpes zoster vaccinations with the Recombinant Zoster Vaccine (RZV) with an interval between the first and second dose of 28 days. Main trial endpoints: The neutralizing antibody titer against the Omicron XBB.1.5. strain 28 days after monovalent Omicron XBB.1.5 COVID-19 vaccination in patients continuing MMF/MPA compared to patients who switched to everolimus. Secondary trial endpoints: - SARS-CoV-2 specific anti-S1 antibody level at 28 and 56 days after COVID-19 vaccination - Varicella zoster specific anti-gE antibody level 28 days after 1st and 2nd herpes zoster vaccination - SARS-CoV-2 specific T-cell response 28 days after COVID-19 vaccination - Varicella zoster specific T-cell response 28 days after 2nd herpes zoster vaccination - Safety in terms of incidence of acute rejection, kidney function decline, SAEs, AESIs and solicited local and systemic AEs after COVID-19 and herpes zoster vaccination

NCT ID: NCT05769049 Completed - Herpes Zoster Clinical Trials

The Safety and Immunogenicity Study of the Recombinant Zoster Vaccine (CHO Cell)

Start date: February 9, 2023
Phase: Phase 1
Study type: Interventional

This is a randomized, observer-blinded, active-controlled Phase I study to evaluate the safety, reactogenicity, and immunogenicity of REC610, when administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older, who do not have known HZ and history of varicella or HZ vaccination. The recombinant HZ vaccine, Shingrix® (GlaxoSmithKline), will be used as the active control.

NCT ID: NCT05756595 Completed - Neck Pain Clinical Trials

A Clinical Study of Freshly Manufactured 35kDa Hyaluronan Fragment in the Treatment of Pain

Start date: July 6, 2020
Phase: N/A
Study type: Interventional

Local used high molecular weight Hyaluronan (HA) with high viscosity has a variety of receptors in the human body, including CD44, LYVE-1, RHAMM, HARE, Siglec-9, TLR2, CEMIP and TMEM2. Intra-articular local injection of HA has a certain degree of analgesic effect. Local injection of HA into the nerve trunk directed by ultrasound was used for the treatment of neuropathic pain. It was reported that the analgesic effect of HA is regulated by TRPV1 ion channels. This study hypothesizes that hyaluronidase cleaves HA to generate low molecular weight HA fragments HA35 with good tissue permeability, which may bind to a variety of HA receptors on the cell surface within the tissues and produce a broad-spectrum analgesic effect. In this study, 35kDa Hyaluronan fragment HA35 was prepared by mixing hyaluronidase PH20 injection and high molecular weight Hyaluronan (HA) injection at room temperature for 20 minutes. In this study, hyaluronidase injection and Hyaluronan injection were off-label used to conduct an investigator-initiated study (IIT or IIS) for the treatment of herpes zoster and shoulder, neck, back and temporal pain.

NCT ID: NCT05639803 Completed - Herpes Zoster Clinical Trials

A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults

Start date: July 7, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase I,randomized, double-blind, placebo controlled,dose escalated,single administrated clinical trial in Chinese healthy adult's volunteers. In the trial, it is planned to enroll 50 subjects, randomized to 5 dosage groups to receive the test drug and the placebo control.

NCT ID: NCT05526820 Completed - Varicella Clinical Trials

A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine

Start date: April 8, 2021
Phase: Phase 4
Study type: Interventional

This study is a randomized and controlled Phase IV clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of combined immunization with live attenuated varicella vaccine and inactivated hepatitis A vaccine in children aged 12-15 months.

NCT ID: NCT05492591 Completed - Herpes Zoster Clinical Trials

A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster

Start date: October 11, 2022
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy, optimal dose and efficacy trend of multiple subcutaneous injections of peginterferon α1b in patients with herpes zoster, and provide support for phase III clinical trials.

NCT ID: NCT05480553 Completed - Clinical trials for Acute Pain in Herpes Zoster

NPC-06 to Pain Associated With Acute Herpes Zoster

Start date: August 5, 2022
Phase: Phase 3
Study type: Interventional

To confirm the pain relief effect and the safety of NPC-06 (fosphenytoin sodium hydrate) in patients with pain associated with acute herpes zoster in a placebo-controlled, double-blind, parallel-group, comparative manner.

NCT ID: NCT05245838 Completed - Herpes Zoster Clinical Trials

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers

Start date: January 10, 2022
Phase: Phase 1
Study type: Interventional

This is a randomized, active-controlled, dose-escalation multi-center study of 2 doses (Day 1 and Week 8) of an investigational herpes zoster (HZ) vaccine (Z-1018), combining herpes zoster antigen- (gE) with a Toll-like receptor 9 (TLR9) agonist adjuvant (CpG 1018) with and without alum in approximately 150 healthy volunteers 50 to 69 years of age (inclusive).

NCT ID: NCT05219253 Completed - Herpes Zoster Clinical Trials

A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India

Start date: February 2, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the humoral immunogenicity and safety of 2 doses of GSK Biologicals' Herpes Zoster subunit vaccine (HZ/su) administered for the prevention of Herpes Zoster (HZ) in adults aged 50 years of age (YOA) or older from India.

NCT ID: NCT05158777 Completed - Varicella Clinical Trials

Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old

Start date: February 13, 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of a two doses vaccination of investigational vaccine with 0,28 day and 0,56 day immunization schedule in population aged ≥13 years old.