Influenza (Flu)

Researchers are evaluating the safety and immune response of an influenza virus split vaccine in adults aged 60 years and older through a randomized, double-blind, controlled phase I clinical trial. The study includes 120 participants divided into three groups to compare an experimental vaccine dose, a control vaccine dose, and a placebo. This research aims to understand how well the vaccine works and its side effects in this age group. Participants receive one injection of either the experimental influenza vaccine (0.7 mL), a control vaccine (0.5 mL), or a placebo, each administered into the upper arm muscle. Forty individuals are randomly assigned to each group in equal proportions. Laboratory tests are performed before vaccination and on the fourth day after vaccination to monitor immune response and safety. During the study, participants are closely monitored for any side effects for up to 30 days, including both expected and unexpected adverse events. Serious side effects are tracked for six months after vaccination. Researchers measure immune responses 30 days post-vaccination by checking antibody levels and rates of immune reaction. The study involves follow-up visits to assess safety and vaccine effectiveness, with participation lasting several months.

Researchers are conducting a long-term observational study across Europe to understand acute respiratory infections (ARI) in adults and children visiting primary care. The study aims to describe how ARI presents and is managed in community care, including infections caused by known and emerging respiratory pathogens. This research will help prepare for future clinical trials by building a research-ready infrastructure in primary care settings. Participants in this study may be part of one of three study protocols: POS-ARI-PC AUDIT, POS-ARI-PC CORE, or the embedded POS-ARI-PC-001 study. The AUDIT protocol involves anonymous registration of ARI cases presenting at primary care facilities. The CORE protocol includes detailed observational study with patient sampling and 28-day follow-up. The embedded POS-ARI-PC-001 study focuses on older adults or those with long-term health conditions and includes swab collection and follow-up procedures. During participation, patients will complete questionnaires about their symptoms and provide throat/nose swabs for analysis. They will be asked to report daily on their health status for up to 14 days using online or paper diaries. Researchers will also review clinical outcomes and hospital referrals up to 28 days after enrollment. Some participants may join optional interviews to share their experiences. The study collects data on illness severity, diagnosis, management, medication use, and return to daily activities to better inform future care and research.

Researchers are evaluating the LIAISON NES FLU A/B, RSV & COVID-19 assay used on the LIAISON NES instrument for detecting and distinguishing influenza A, influenza B, RSV, and SARS-CoV-2 viruses in patients showing symptoms of respiratory tract infections. This test is designed to help in the differential diagnosis of these infections in a professional laboratory setting, but negative results alone should not guide patient management as they do not rule out infection. The study is interventional and involves multiple sites. The trial involves collecting clinical specimens, mainly nasal swabs, from symptomatic patients. These specimens are collected prospectively by healthcare professionals, with up to 40% possibly self-collected under supervision. Nasopharyngeal swabs may also be collected by professionals, especially in children 13 years or younger. The assay uses real-time polymerase chain reaction (RT-PCR) to detect viral RNA directly from dry nasal swabs without the need for nucleic acid extraction. Participants will provide nasal or nasopharyngeal swabs preserved in specific transport media, which are tested on the LIAISON NES instrument within one to two hours of collection. The study measures the diagnostic accuracy and clinical performance of the assay. Specimens are carefully stored and handled to maintain quality. The trial monitors conditions including influenza A, influenza B, RSV, and COVID-19 infections and is expected to complete by May 2025.

Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drug's safety profile. Participants will be divided into two main groups: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are evaluating the antiviral effects of various treatments in adults aged 18 to 60 with early symptomatic influenza. This phase 2, multi-centre, adaptive platform trial compares several licensed influenza antiviral drugs and others with potential activity against the virus. The study aims to provide clear comparisons of antiviral activity to help guide treatment decisions and policy development. Participants may receive one of several antiviral drugs such as oseltamivir, favipiravir, zanamivir, baloxavir, molnupiravir, peramivir, laninamivir, or combinations of these medications. There is also a control group that receives no antiviral treatment except paracetamol for fever. Dosages and administration routes vary by drug and include oral, inhaled, and intravenous methods. The trial uses randomization to assign treatments, with at least 20% of participants assigned to the no treatment group. During the first five days, researchers will monitor the rate of viral clearance to assess antiviral activity. Additional measures include symptom relief and fever duration over 14 days. Participants will be closely followed up, with assessments including rapid antigen or PCR tests for influenza, symptom tracking, and safety monitoring. The total study period covers initial treatment and observation up to two weeks after starting treatment.

Researchers are evaluating the protective efficacy and safety of a recombinant herpes zoster vaccine called LZ901 in healthy adults aged 40 years and older. This phase 3, randomized, double-blind, placebo-controlled trial aims to protect participants against shingles caused by the varicella zoster virus. The vaccine contains a tetramer of VZV glycoprotein E combined with an aluminum hydroxide adjuvant known to enhance immune response and widely used in vaccines worldwide. Participants will receive two doses of either the LZ901 vaccine or a placebo (aluminum hydroxide adjuvant) injected into the upper arm on day 0 and day 29. Around 26,000 participants will be enrolled, including a subgroup of about 3,000 to assess the consistency of immune response across three vaccine batches and monitor persistence of immunity up to 36 months. The study includes four groups: treatment main, placebo main, treatment immunization, and placebo immunization groups. Participants will undergo up to 24 visits depending on their group, including on-site and in-person visits for screening, vaccination, and follow-up assessments. Researchers will monitor vaccine efficacy 30 days after full immunization, track adverse events from immediate to 12 months post-vaccination, and evaluate immune response through antibody tests at multiple time points. The study also explores the vaccine's impact on reducing the severity and occurrence of postherpetic neuralgia in adults 40 years and older.

Researchers are evaluating the safety and effectiveness of a drug called AP1189 in people with respiratory insufficiency expected to be caused by respiratory viral infections such as influenza, respiratory syncytial virus, and coronavirus. This randomized, double-blind, placebo-controlled, multicenter proof-of-concept clinical trial aims to add AP1189 to the standard care and observe its impact compared to a placebo. The study plans to enroll 96 participants and is sponsored by SynAct Pharma Aps. Participants will be randomly assigned to one of two groups: one group receives 100 mg of oral AP1189 once daily for 14 days alongside standard care, while the other group receives a matching placebo under the same conditions. This treatment period lasts for 14 days, and the study is designed to measure outcomes up to 28 days after treatment begins. During the study, participants will undergo various assessments to track their health and response to treatment. Researchers will monitor key outcomes such as death, the need for invasive mechanical ventilation, use of extracorporeal membrane oxygenation (ECMO), cardiovascular organ support, and renal failure up to 28 days from baseline. The study includes hospital assessments and close monitoring to evaluate safety and efficacy, lasting through the treatment and follow-up periods.

Researchers are investigating whether adding a rapid biomarker test to current clinical guidelines can better identify young children with fever who are at risk of serious infections in sub-Saharan Africa. This study compares standard care based on integrated management of childhood illness (IMCI) guidelines alone to an approach enhanced by measuring suPAR levels, a biomarker, during the first clinical assessment. The goal is to see if this combined strategy improves decisions about hospital admission or discharge and leads to better health outcomes for children aged 2 to under 60 months. The trial is a multi-country, open-label, randomized study with two groups: one receiving the standard IMCI-based care and the other receiving IMCI care plus a point-of-care suPAR test. Blood samples will be taken from all children, but only the intervention group will have their suPAR levels measured immediately. Clinicians will use these results along with IMCI guidelines to decide whether to admit or discharge each child during the first clinical visit. A second, more detailed clinical assessment will also be performed on all participants to confirm or adjust decisions and ensure safety. Children will be followed up on days 3 and 7 after enrollment with additional visits if clinical worsening occurs. A day 28 follow-up will collect information on serious events, hospitalizations, or deaths, with an optional extra interview at three months. Participants with respiratory symptoms may join a substudy involving lung exams and sample collections. The study team will measure outcomes like the appropriateness of discharge decisions, hospital admissions, severity of illness, and mortality to evaluate the new triage approach's effectiveness and safety over these timeframes.

Researchers are evaluating INNA-051, an intranasal powder designed to boost the innate immune system, to see if it can safely reduce the occurrence, severity, or duration of respiratory viral infections in generally healthy adults aged 18 to 45 who are at risk of exposure due to their living or work environments. This Phase 2a trial focuses on viral respiratory infections, which are a major health concern worldwide and cause significant illness and death. Toll-like receptors targeted by INNA-051 play a key role in the body's immune defense against viruses. The study has two parts: Part A tests the safety and tolerability of INNA-051 when self-administered once weekly for 4 weeks during the respiratory virus season, compared to placebo. Part B evaluates safety, tolerability, and effectiveness over 12 weeks of weekly INNA-051 use in preventing symptoms from laboratory-confirmed respiratory viral infections. Both parts use a randomized, double-blind, placebo-controlled design, with participants using the nasal spray at home. Participants will be monitored through clinical assessments, questionnaires on nasal symptoms, and laboratory tests including blood counts and liver function over the treatment periods and follow-up weeks. In Part B, researchers will track the number of symptomatic infections confirmed by RT-qPCR, symptom severity scores, time to symptom resolution, infection duration, and quality of daily living. Safety is assessed by recording any adverse events throughout the study, which lasts up to 16 weeks depending on the part enrolled.

Researchers are evaluating the immune response and safety of the mRNA-1018-H5 vaccine against pandemic influenza in healthy adults aged 18 years and older. The study aims to measure how well the vaccine triggers protective antibodies and to monitor any side effects or reactions. This is a phase 3 randomized trial sponsored by ModernaTX, Inc., focusing on adults without significant health issues or with stable chronic conditions. Participants will be randomly assigned to receive either the mRNA-1018-H5 vaccine or a placebo. Both are given as intramuscular injections on Day 1 and Day 22. The vaccine is a sterile liquid designed for injection. The study includes a blinded design to ensure unbiased safety and immunogenicity assessments. Participants may be monitored for up to 205 days to assess antibody levels and adverse events. During the study, participants will have blood tests to measure antibody responses on Days 22, 43, and 205. Researchers will track local and systemic reactions for 7 days after each injection and any adverse events for up to 205 days. The main outcomes include the percentage of participants achieving protective antibody levels, immune response strength, and safety measures. Participants will be involved in regular visits and evaluations throughout the study period.