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Influenza, Human clinical trials

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NCT ID: NCT02927431 Terminated - Virus Diseases Clinical Trials

Study to Evaluate the Efficacy and Safety of Danirixin Co-administered With Oseltamivir in the Treatment of Adults Hospitalized With Influenza

Start date: January 19, 2017
Phase: Phase 2
Study type: Interventional

Danirixin (DNX) is a novel, selective, and reversible antagonist of the C-X-C chemokine receptor (CXCR) 2 and has been shown to decrease neutrophil transmigration and activation to areas of inflammation. An intravenous (IV) formulation of DNX hydrobromide (HBr) is being developed as an anti-inflammatory agent for treatment of adults hospitalized with influenza (IFV). While early therapy with antivirals decreases severity and duration of symptoms of influenza, there are no drugs that have demonstrated clinical efficacy in randomized clinical trials in this population. Current treatment guidelines for hospitalized IFV recommend neuraminidase inhibitors as standard of care therapy. IFV studies in animals have demonstrated that therapeutic treatment with the combination of a CXCR2 antagonist and a neuraminidase inhibitor reduced lung neutrophils and showed trends for improvements in clinical scores, lung function and pathology with no evidence of worsening outcomes, including viral load. This Phase 2, randomized, double-blind (for IV DNX), placebo-controlled (for IV DNX) 3-arm study will be the first study to determine the efficacy and safety of IV DNX when co-administered (in all groups) with standard of care antiviral treatment (open-label oral oseltamivir [OSV]) in subjects hospitalized with IFV. The primary objective of the study is to assess the efficacy of treatment with IV DNX twice daily given with oral OSV compared to oral OSV twice daily on time to clinical response (TTCR). In this study, subjects will be randomized in a 2:2:1 ratio to 15 milligram (mg) free base equivalent (FBE) IV DNX, 50 mg FBE IV DNX, or matching placebo twice daily. All subjects will also receive open-label 75 mg oral OSV, twice daily (given as standard of care). The study treatment duration will be for up to 5 days. The investigator may elect to continue treatment with OSV after 5 days of study treatment. Follow up will continue until Day 45 for all subjects. The study will begin with enhanced safety monitoring in sentinel cohorts, leading to stepwise enrollment of subjects. Subjects will be enrolled based on increasing levels of renal impairment, and less severe hospitalized subjects will be enrolled prior to enrollment of critically ill subjects, as this is the first study conducted in the hospitalized population with severe IFV. Approximately 300 subjects are targeted to be enrolled in the study.

NCT ID: NCT02883426 Terminated - Influenza Clinical Trials

Evaluating the Safety and Immunogenicity of a Live Attenuated Virus Vaccine to Prevent Influenza H3N2v Disease

Start date: September 2016
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old.

NCT ID: NCT02755948 Terminated - Influenza, Human Clinical Trials

A Study of Protective Immunity Against RSV and Influenza in Experimental Human Challenge of Volunteers

Start date: April 2012
Phase: N/A
Study type: Interventional

Respiratory viruses including influenza and respiratory syncytial virus (RSV) are among the most important causes of severe disease globally, infecting everyone repeatedly throughout life. Understanding of how to prevent infection is incomplete but boosting immunity with vaccines remains the best strategy. T cells have been shown in animals to be essential for clearing respiratory viral infection and are likely to be helpful if stimulated by vaccines. However, where these cells originate from and how they develop in the human lung are still unclear. The investigators will inoculate volunteers with influenza or RSV to examine the relationship between T cells in their blood and lungs and the outcome of infection. By tracking these specialised cells, the investigators aim to develop a better understanding of how they are generated in order to harness them with future vaccines.

NCT ID: NCT02561169 Terminated - Influenza Clinical Trials

A Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza

Start date: December 2015
Phase: Phase 4
Study type: Interventional

A multi-centre, randomized, placebo controlled, trial. Participants will be patients either ≥65 years or with one or more high risk conditions presenting to one of four academic emergency departments in Edmonton or Calgary with influenza-like illness. The investigators will test for influenza using a point-of-care rapid test and if positive for influenza participants will be randomized to oseltamivir or placebo and followed prospectively. The primary outcome will be hospitalization.

NCT ID: NCT02485639 Terminated - Influenza Clinical Trials

Analysis of Bone Marrow and Blood B Cell Immune Responses to Influenza Vaccination

Start date: December 23, 2015
Phase: Phase 4
Study type: Interventional

This was a Phase IV open label and single arm study, with the aim of enrolling up to 55 healthy males and non-pregnant females in a single site, age 18-49 years old, inclusive. This study was designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults. Total enrollment was 27 participants. This was a multi-year study. After one year of participation, participants were offered the opportunity to participate in the study for up to 3 consecutive years, provided eligibility criteria was met each year. Participants who elected to continue in the study after first year of participation were rescreened to verify continued eligibility and re-consented prior to subsequent participation. The primary study objective was to investigate the longevity of humoral immunity to influenza virus in humans. Note: Due to the Coronavirus Disease of 2019 (COVID-19) pandemic, all non-essential research was halted in mid-March 2020. New enrollments were placed on hold for this study. Follow-up visits were also halted, which impacted the timing of participants' subsequent follow-up visits. Participant visits for Day 7 and Day 14 were not impacted. For this study, there were participants whose Day 28 and Day 90 visits were impacted by the temporary halting of non-essential research studies. As such, a request was submitted to the Emory University Institutional Review Board to extend the missed visit windows for the Day 28 and Day 90 visits for a maximum of up to 180 days, to ensure that ample time was available to bring participants back for their missed visits. Enrollment for this study ended on March 31, 2020, before research activities could resume at Emory.

NCT ID: NCT02385123 Terminated - Influenza Clinical Trials

Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers

Start date: April 1, 2015
Phase: Phase 4
Study type: Interventional

This was an open label, single arm, Phase IV study of longitudinal immunologic responses to influenza vaccine in healthy adult participants, with the aim of enrolling up to 70 participants. This study enrolled males and non-pregnant females, 18-49 years old, inclusive. The participants were screened at enrollment with a history and physical exam and laboratory testing to ensure they were healthy enough to participate. Total enrollment was 60 participants. Qualifying participants were vaccinated with an FDA approved seasonal inactivated influenza vaccine (IIV) according to the package insert. The study enrolled a total 60 participants. The primary objective of the study was to characterize HA-specific plasmablasts and memory B cells after influenza vaccination. Note: Due to the Coronavirus Disease 2019 (COVID-19) pandemic, all non-essential research was halted in mid-March 2020. New enrollments were placed on hold for this study. Follow-up visits were also halted, which impacted the timing of participants' subsequent follow-up visits. Five participants had their Day 180 visits halted due to the COVID-19 pandemic.

NCT ID: NCT02014649 Terminated - Influenza Clinical Trials

Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza

FROSTY
Start date: November 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints.

NCT ID: NCT02014168 Terminated - Influenza Clinical Trials

Safety and Immunogenicity of Co-administration of Candidate Influenza Vaccine MVA-NP+M1 and Viroflu® Seasonal Influenza Vaccine

Start date: January 2014
Phase: Phase 1
Study type: Interventional

This is a single blinded placebo controlled phase I study, to assess the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with the Viroflu® seasonal influenza vaccine. All volunteers recruited will be healthy adults aged 18 and over.

NCT ID: NCT01690637 Terminated - Influenza Clinical Trials

Panama and El Salvador Children's Oseltamivir Study

PECOS
Start date: September 2012
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized, double-blind, placebo-controlled trial that will be conducted in tertiary care pediatric hospitals in El Salvador and Panama. The primary purpose of this study is to determine whether empiric oseltamivir phosphate treatment given at the time of hospital admission to children less than 10 years of age hospitalized with influenza can effectively reduce their illness severity. Additional objectives are to: 1) evaluate the tolerability of oseltamivir phosphate treatment, 2) evaluate the effect of oseltamivir treatment on viral clearance and development of oseltamivir-resistant influenza virus during and after treatment in children hospitalized with influenza, 3) estimate the direct and indirect costs of all-cause respiratory illness and influenza-associated respiratory illness requiring hospitalization, and 4) evaluate the effect of empiric oseltamivir treatment during the influenza season on these costs. The primary study hypothesis is that children with laboratory-confirmed influenza receiving empiric oseltamivir phosphate treatment initiated at the time of hospital admission will have a shorter duration of hospitalization and a shorter time to resolution of signs of severe respiratory illness compared to children receiving placebo. The secondary study hypotheses are that children with laboratory-confirmed influenza receiving oseltamivir phosphate treatment will have a reduction in the time to non-detectable influenza virus and influenza viral RNA and children with all-cause respiratory illness receiving oseltamivir phosphate will not be more likely to experience severe adverse events than children receiving placebo.

NCT ID: NCT01673425 Terminated - Influenza Clinical Trials

Evaluating Immune Response to Seasonal FluMist in Healthy Adults

Start date: September 2012
Phase: N/A
Study type: Interventional

The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be effective in children but less effective in adults. Our hypothesis is that this relative failure is due to adults having enough anti-flu IgA antibody in nasal secretions to neutralize the weakened vaccine virus.