Clinical Research Directory

Shingrix in Renal Transplant Recipients

The goal of this clinical trial is to learn how well the shingles vaccine (Shingrix) works and how safe it is in adults with kidney failure who are waiting for a kidney transplant, including those who later receive a transplant. The study also aims to find out whether giving an extra (third) dose of the vaccine after transplant improves protection. The main questions it aims to answer are: How strong is the body's immune response to the vaccine at different time points (about 1 month, 2 years, and 3 years after vaccination) in people waiting for a kidney transplant? Does a third dose of the vaccine after transplant improve the immune response compared to not receiving a third dose? How long does protection from the vaccine last before and after transplant? How safe is the vaccine in this group, including whether it affects transplant-related immune markers? Researchers will compare people who receive a third dose of the vaccine after transplant to those who do not receive a third dose, as well as to results from similar groups studied in the past, to see if the extra dose improves immune protection. Participants will: Be screened to see if they can take part in the study Attend about 3 to 6 study visits over approximately 30 to 37 months Receive two doses of the shingles vaccine if they have not already been vaccinated, or complete study assessments if they were vaccinated before joining If they receive a kidney transplant during the study, be randomly assigned (by chance) to receive either a third dose of the vaccine or no additional dose Complete questionnaires, have physical exams if needed, and provide blood (and urine, if applicable) samples at study visits Take part in follow-up visits to check immune response and safety, with the option to allow samples to be stored for future research Shingrix is approved for adults aged 50 and older and for younger adults with weakened immune systems. However, giving a third dose after a kidney transplant is not standard practice and is being studied in this trial.

A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals

The purpose of this clinical study is to evaluate the safety and immunogenicity of receiving two doses of recombinant herpes zoster vaccine (CHO cells) (RHZV) in healthy individuals aged 40 years and above. This study will be conducted in 2 substudies: Substudy A (Phase I) and Substudy B (Phase Ⅱ).

A Immunogenicity and Safety Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 40 Years and Older

This phase 2 study in China will evaluate the immunogenicity and safety of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.

A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.

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.

Clinical Study on the Treatment of Herpes Zoster Pain With Dexmedetomidine Combined With Long-term High Voltage

Participants will be invited to take part in clinical research. This informed consent form will provide information to the participants to help them decide whether to participate in the clinical study. If participants have any questions, please ask them directly to the researcher in charge of this study. This study was approved by the Biomedical Research Ethics Review Committee of the Institute. This trial is a randomized controlled clinical study. According to the different treatment methods, the control group was randomly divided into the control group and the experimental group. Control group: On the basis of conventional drug treatment, long-term high-voltage pulsed radiofrequency treatment was carried out. Experimental group: On the basis of conventional drug treatment, dexmedetomidine nasal spray was administered before HL-PRF treatment, before bedtime on the day of the operation, and before bedtime on the 1st to 3rd days after the operation. Heart rate, blood pressure and blood oxygen saturation were monitored respectively before the operation, during the operation and after the operation. Telephone follow-ups were conducted at 1 week, 1 month, 3 months and 6 months after the operation respectively. If the participants agree to participate in this study, the researchers will number the participants and establish medical records. The researchers will have detailed communication with the participants or their families, inform them of the research situation, and ask the participants to provide disease information, including the onset of the disease, family history, previous medical visits and some examination results. What do you need to do in this research? Once participating in the study, participants will be required to provide true information about their medical history and current physical condition. Tell the research doctor about any discomfort you encountered during the research process; Do not take restricted drugs, foods, etc. Tell the research doctor whether you have participated in or are currently participating in any other research recently. Risks and discomfort: Communicating and talking with researchers may cause participants to feel psychologically uncomfortable. Since this study only collected the medical history, data and epidemiological investigation of patients or normal people, there is no harm in this study. If participants are injured during the clinical trial, they can receive free treatment and/or appropriate compensation in accordance with Chinese law. What are the benefits of participating in this research? Useful information can be provided for disease research by studying the information of the participants. The cost of participating in this study: Participation in this study will be based on the medical information of the research participants, and the related costs will not be borne by the participants. Privacy issue: If participants decide to take part in this study, their participation status and personal data during the study period will be kept confidential. When necessary, government administrative departments or members of the ethics review committee may access the personal data of participants in research institutions. When the results of this study are announced, the personal identity information of the participants will not be disclosed.

Comparative Efficacy of Pregabalin and Lacosamide in Patients With Herpes Zoster and Post Herpetic Neuralgia

Post-herpetic neuralgia (PHN) is the most significant complication of herpes zoster caused by reactivation of latent Varicella-Zoster virus (VZV). PHN is characterized by neuropathic pain lasting beyond the resolution of the rashes. Post herpetic neuralgia (PHN) represents a potentially debilitating and often undertreated form of neuropathic pain that disproportionately affects vulnerable populations, including the elderly and the immunocompromised. PHN pain is typically localized, unilateral and chronic, but may be constant, intermittent, spontaneous and/or evoked. PHN is likely to interfere with sleep and daily activities. Pregabalin is a gabapentinoid licenced for treatment of neurological disorders. It is one of the earlier drugs approved by the US Food and Drug Administration (2004) for the treatment of painful diabetic neuropathy and postherpetic neuralgia (PHN). Lacosamide (LCM) was approved in 2008 in the European Union and in the United States as adjunctive therapy for the treatment of focal-onset seizures with or without secondary generalization in adults and adolescents with epilepsy. Its efficacy has also been proven in neuropathic pain. Although Pregabalin and Lacosamide have proven effective in various neuropathic pain disorder, comparative studies specifically for PHN remain scarce. This study aims to compare the efficacy of Pregabalin and Lacosamide in PHN patients, addressing the current gap in literature and providing clinically relevant insights to optimize treatment selection.

Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older

This phase 1 study in China will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.

A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine

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.

Neuropathic Pain and Traditional Medicine Syndromes in Herpes Zoster: a Cross-Sectional Study

This study investigates the relationship between neuropathic pain characteristics and Traditional Chinese Medicine (TCM) syndromes in patients with Herpes Zoster (HZ). The study aims to integrate objective pain assessment tools, such as the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale, with TCM diagnostic classifications to enhance individualized treatment strategies. Conducted at Le Van Thinh Hospital, Vietnam, this cross-sectional study includes 80 HZ patients, assessing their pain levels and corresponding TCM syndromes. The findings will contribute to a more comprehensive approach to pain management in Herpes Zoster.

Multimodal Nerve Block and Pulse Radiofrequency for Acute Herpes Zoster Pain

The primary objective of this clinical trial is to evaluate the efficacy of liposomal bupivacaine and ropivacaine in the treatment of pain associated with herpes zoster (shingles). This trial will also assess the safety profiles of both liposomal bupivacaine and ropivacaine. The study aims to address the following key questions: Does nerve blockade with liposomal bupivacaine or ropivacaine reduce the required dosage of gabapentin in participants? What medical issues, if any, arise in participants undergoing paravertebral block, intercostal nerve block, RISS (Radiofrequency Intervention for Spinal Segment); or pulsed radiofrequency (PRF)? Can nerve blocks, specifically paravertebral block, intercostal nerve block, RISS; and PRF, effectively treat severe postherpetic neuralgia (PHN)? The study will compare these interventions. Study Procedures: Participants will:Receive ultrasound-guided nerve blocks or pulsed radiofrequency every 48 hours, for a total of 3 treatments. Undergo assessments, either in-person or via telephone, at the following time points: before therapy (baseline), on the day of treatment (Day 1), Day 7, Day 30, and Day 90 post-treatment. Have their symptoms recorded, along with their scores on the Numerical Rating Scale (NRS) and the Zoster Brief Pain Inventory (ZBPI).

Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia

The investigators' objectives are to examine the longitudinal association of obesity and obesity-related factors and risk of incident herpes zoster (HZ), also known as shingles, and the longitudinal association of obesity and obesity-related factors and risk of developing post-herpetic neuralgia (PHN) among those with HZ. The investigators propose to examine more refined assessments of adiposity, leveraging the resources of several large-scale ongoing cohort studies of women and men with decades of follow-up and rich health-related data, including multiple validated anthropomorphic measures, medical history, dietary intake, and lifestyle factors. The investigators will also examine existing data on plasma adipokines, cytokines, and plasma metabolomics. The investigators will use the Nurses' Health Study (NHS I), Nurses' Health Study II (NHS II), and the Health Professionals Follow-up Study (HPFS) (total N\>200,000) to prospectively investigate whether obesity and obesity-related factors influence the risk of developing HZ. The investigators have already identified \>30,000 cases of incident HZ among the 3 cohorts (reported with high validity) and information on HZ continues to be collected. In addition, the investigators obtained detailed information on HZ course, complications (including PHN), treatment and other related factors on a Zoster Supplemental Questionnaire (ZSQ) administered to those participants in the NHS I and II who reported "shingles" on the main questionnaires (n=10,123 to date). The investigators will also administer the ZSQ to newly identified HZ cases identified on the 2023 NHS I and NHS II biennial questionnaires. No previous study has investigated the longitudinal relation between adiposity and risk of post-herpetic neuralgia (PHN). This study could provide important new insight into how obesity and obesity-related factors influence the risk of HZ, and the risk of developing PHN among individuals with HZ, and how alterations in circulating metabolites and metabolic pathways, including those that are obesity-related, are associated with risk of developing HZ and PHN.