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Virus Diseases clinical trials

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NCT ID: NCT06036602 Not yet recruiting - Clinical trials for Ebola Sudan Virus Disease

Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults

Start date: February 2024
Phase: Phase 2
Study type: Interventional

A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults

NCT ID: NCT05992480 Not yet recruiting - Ebola Virus Disease Clinical Trials

REVIVE (Response to the Ebola Virus Vaccine)

Start date: August 15, 2024
Phase: Phase 4
Study type: Interventional

This study is a vaccine-related clinical trial which will be conducted by our study team at Kenema Government Hospital (KGH)'s Viral Hemorrhagic Fever Program in collaboration with Tulane University School of Medicine. This study is funded by Merck & Co., the developers of ERVEBO®. This investigational medicinal product (IMP) was successful in Sierra Leone through the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) working with the College of Medical and Allied Health Services (COMAHS) at the University of Sierra Leone. ERVEBO® was also successfully tested in Liberia and the Republic of Guinea. These successful trials led to the United States Food and Drug Administration (USFDA) approval of ERVEBO®, as well as approval for therapeutic use in the Democratic Republic of the Congo, Burundi, Ghana, and Zambia. This particular vaccination study will focus on the anamnestic response to the ERVEBO® vaccine, (full name - rVSVDG-ZEBOV-GP Ebola Virus Vaccine). The original clinical trials conducted excluded Ebola Virus Disease (EVD) survivors from participating. However, with ongoing research, there is evidence of waning immune response and even recurrent infections in EVD survivors.

NCT ID: NCT05953233 Not yet recruiting - Viral Infection Clinical Trials

School Inner City Air Study

Start date: September 2023
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to test the efficacy of high efficiency particulate air (HEPA) cleaners in reducing respiratory viral exposure and infections in elementary school classrooms. Classrooms will be randomized to active vs. sham HEPA cleaners. The main questions it aims to answer are: - Do classroom HEPA cleaners reduce exposure to viruses? - Do classroom HEPA cleaners reduce student and teacher infections? - Do classroom HEPA cleaners reduce infections in family members?

NCT ID: NCT05946538 Not yet recruiting - Clinical trials for Respiratory Viral Infection

Clinical Evaluation of SARS-COV-2 (COVID-19), Influenza and RSV 8-Well MT-PCR Panel for In Vitro Diagnostics

Start date: July 2023
Phase: N/A
Study type: Interventional

This study is a prospective accuracy observational study to evaluate the performance of the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical device panel and generate performance data. The precision of results will be evaluated in concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1).

NCT ID: NCT05902702 Not yet recruiting - Asthma in Children Clinical Trials

Isotonic Saline for Children With Bronchiolitis

Start date: September 2023
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to investigate the optimal supportive treatment of bronchiolitis in infants from 0-12 months of age. The main question[s] it aims to answer are: - To investigate whether isotonic saline should be used as supportive treatment for children with bronchiolitis, and if so, identify the optimal route of administration. The primary outcome is duration of hospitalization. - To investigate the current epidemiology of the viral pathogens causing bronchitis in children in Denmark, and to assess whether children infected with specific pathogens might benefit from treatment with isotonic saline. The children are randomized after inclusion through computer randomization to one of the 3 arms in the study: 1. Nebulized isotonic saline 2. Nasal irrigation with isotonic saline 3. No treatment with saline The investigators will compare treatment with saline (both methods) with no treatment, and the investigators will also compare the two methods of delivery of saline (nebulized vs. nasal irrigation).

NCT ID: NCT05897138 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

A Study to Evaluate Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses

Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses.

NCT ID: NCT05888649 Not yet recruiting - Ebola Virus Disease Clinical Trials

Community Preparedness for Outbreak Response and Readiness for Ebola Vaccination in Liberia

Start date: June 2023
Phase:
Study type: Observational

This community-based mixed methods study intends to identify, explore, and assess the determinants of community preparedness for outbreak situations, including acceptance for Ebola vaccines.

NCT ID: NCT05813691 Not yet recruiting - Hepatitis C Clinical Trials

Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.

ERADIcATE
Start date: April 10, 2023
Phase:
Study type: Observational

The goal of this monocentric prospective observational study is to evaluate the prevalence of unknown hepatitis C virus chronic infection in general population born before january 1st 1968 in Italy. The main questions it aims to answer are: what is the prevalence of hepatits C virus infection in general population born before January 1st, 1968? What rare the characteristics of these patients compared to the general population? What is the prevalence of patients tested HCV positive who are referred to the Hepatology Outpatient Clinic for further evaluation? What is the prevalence of patients with HCV infection detected during the study and treated with direct antiviral agents during follow up? Participants will be tested with a point of care screening test (Meridian, Bioscience) able to detect anti-HCV antibodies to detect the presence of antibodies against HCV.

NCT ID: NCT05771402 Not yet recruiting - Chronic Hepatitis b Clinical Trials

A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (B)

Start date: June 1, 2023
Phase: Phase 4
Study type: Interventional

Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of HBV treatment. However, HBsAg loss can be achieved in less than 10% of chronic hepatitis B (CHB) patients treated with current available antiviral drug interferon (IFNα) or nucleos(t)ide analogues (NAs) monotherapy. With the support of the national major special funding for infectious diseases from "11th Five-Year Plan" to "13th Five-Year Plan", we have implemented a pioneer clinical study of sequential combination of IFNα therapy on NAs to treat NAs-treated CHB patients (ie. New Switch Study). This is the world's first clinical trial aiming to functional cure, which increased the rate of HBsAg loss to 15% in the overall population in our study, and to 30-50% among those with lower baseline HBsAg levels. How to further improve the HBsAg loss rate is an urgent issue for us. The key point of achieving functional cure is to reverse the HBV-specific T cell exhaustion and establish the long-term immune control against HBV infection. (Programmed death-1) PD-1/programmed death-ligand 1 (PD-L1) axis blockade has been demonstrated to reinvigorate exhausted CD8+ T cells, and would be a potential strategy to treat chronic HBV infection. In this study, a large multicenter prospective study will be performed to explore the safety and efficacy of a novel combination strategy involving immune checkpoint inhibitor (anti-PD-1 antibody) and IFNα in CHB patients, observe the HBsAg loss rate in NA-treated CHB patients receiving this combination strategy, evaluate the potential of breaking immune tolerance by this strategy, and further assess its efficacy to further improve the clinical cure rate on the basis of New Switch Study. Based on New Switch Study, this study further attempts to reverse T cell exhaustion in CHB patients, explore a novel platform of combination therapy development for clinical cure, and ultimately increase the HBsAg loss rate to higher than 50% in overall patients. The implementation of the project is expected to reduce the burden of HBV infection in China and contribute to the goal of global elimination of hepatitis B and C by 2030 (WHO 2030).

NCT ID: NCT05769816 Not yet recruiting - Chronic Hepatitis b Clinical Trials

A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (A)

Start date: June 1, 2023
Phase: Phase 4
Study type: Interventional

Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of HBV treatment. However, HBsAg loss can be achieved in less than 10% of chronic hepatitis B (CHB) patients treated with current available antiviral drug interferon (IFNα) or nucleos(t)ide analogues (NAs) monotherapy. With the support of the national major special funding for infectious diseases from "11th Five-Year Plan" to "13th Five-Year Plan", we have implemented a pioneer clinical study of sequential combination of IFNα therapy on NAs to treat NAs-treated CHB patients (ie. New Switch Study). This is the world's first clinical trial aiming to functional cure, which increased the rate of HBsAg loss to 15% in the overall population in our study, and to 30-50% among those with lower baseline HBsAg levels. How to further improve the HBsAg loss rate is an urgent issue for us. The key point of achieving functional cure is to reverse the HBV-specific T cell exhaustion and establish the long-term immune control against HBV infection. Programmed death-1 (PD-1)/ programmed death-ligand 1 (PD-L1) axis blockade has been demonstrated to reinvigorate exhausted CD8+ T cells, and would be a potential strategy to treat chronic HBV infection. In this study, a large multicenter prospective study will be performed to explore the safety and efficacy of a novel combination strategy involving immune checkpoint inhibitor (anti-PD-1 antibody) in CHB patients, observe the HBsAg loss rate in NA-treated CHB patients receiving this combination strategy, evaluate the potential of breaking immune tolerance by this strategy, and further assess its efficacy to further improve the clinical cure rate on the basis of New Switch Study. Based on New Switch Study, this study further attempts to reverse T cell exhaustion in CHB patients, explore a novel platform of combination therapy development for clinical cure, and ultimately increase the HBsAg loss rate to higher than 50% in overall patients. The implementation of the project is expected to reduce the burden of HBV infection in China and contribute to the goal of global elimination of hepatitis B and C by 2030 (WHO 2030).