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NCT05945485
This is a Phase 1, single-site, comparator-controlled, dosage-escalating study of an intramuscularly administered mRNA-LNP vaccine encoding for DCVC H1 HA in up to 50 adult volunteers aged 18 to 49 years, inclusive. This study is designed to assess the safety and immunogenicity of two doses of DCVC H1 HA mRNA vaccine administered 28 days apart. Eligible participants will be sequentially enrolled into dosage escalation groups (10 mcg, 25 mcg, and 50 mcg). A separate group of 10 participants will receive one dose of the licensed quadrivalent influenza vaccine (IIV4). Enrollment of participants into the IIV4 group is limited to when the vaccine is available for a given year. Concurrent enrollment of the IIV4 group and any pre-specified study product group or groups may present logistical challenges due to the availability of the IIV4 vaccine and may preclude enrollment of all study participants prior to the subsequent off-season. Participants receiving IIV4 will be followed for safety but only their immune responses will be compared to those of participants receiving DCVC H1 HA mRNA vaccine. Dosing of DCVC H1 HA mRNA vaccine will commence at the lowest dose (10 mcg) and only escalate to the next highest dose if safety concerns are not identified. For each DCVC H1 HA mRNA vaccine dosing group, the first two participants enrolled will be considered the sentinel subgroup. After the two participants in the Low Dose sentinel subgroup are enrolled and given their first vaccination, enrollment and subsequent vaccinations in that dosing group will then be stopped until Day 3. This review will be conducted by a Safety Review Committee (SRC). If no halting criteria are met, the SRC will allow administration of the second dose for the sentinel subgroup and continued enrollment of the remaining 8 Low Dose Group participants (expanded subgroup) to complete enrollment of 10 participants. In order for a timely receipt of a second dose of study product on Day 29, SRC review and approval must occur prior to Study Day 28 for the first sentinel participant in the Low Dose Group. After the Low Dose Group enrollment is completed and both doses have been administered, enrollment will be stopped pending SRC review. After all participants in the Low Dose Group have completed the Day 36 visit, the SRC will review the clinical laboratory, reactogenicity, and adverse event information through the Day 36 visit for all Low Dose Group participants that received two doses. Approval by the SRC will allow dose escalation and initiation of enrollment of the Medium Dose Group sentinel subgroup. The Medium and High Dose sentinel and expanded groups will be enrolled as described above for the Low Dose sentinel and expanded groups, respectively, with the High Dose expanded subgroup enrolling up to 18 individuals. The primary objective of this study is to assess the safety of two doses of DCVC H1 HA mRNA Vaccine administered intramuscularly in healthy adults (18-49 yrs) at dosage levels of 10 mcg, 25 mcg, and 50 mcg.
NCT07215858
Background: Influenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it. Current vaccines protect against seasonal flus, but broader vaccines are needed to protect against potential flu pandemics. Objective: To test an experimental flu vaccine. Eligibility: Healthy people aged 18 to 55 years. Design: The study will last 5 to 8 months and has 2 phases, A and B. The study vaccine will be given either as a shot in the arm or as a nasal spray. Participants will receive 1 of 3 combinations: (1) study vaccine in the nose and placebo in the arm; (2) placebo in the nose and study vaccine in the arm; or (3) placebo in the nose and placebo in the arm. A placebo is just like the real vaccine but contains no active ingredients. Phase A: Participants will have 5 clinic visits over 56 days. They will receive a shot and a nasal spray at 2 of the visits, 28 days apart. At each visit, they will have a physical exam, with tests of their blood, urine, and nasal secretions. They will check their temperature at home and record any symptoms for 7 days after each vaccine. Phase B: Participants will stay in the hospital for at least 9 days. They will be infected with a flu virus. They will provide blood, urine, and nasal fluid samples. They will have tests of their heart function. They will remain in the hospital until they test negative for the flu 2 days in a row. They will have 2 follow-up visits, 4 and 8 weeks after leaving the hospital.
NCT05227001
The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who: * Are between the age of 18 to 49 years old. * Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Are healthy as determined by medical history, physical examinations, and the study doctor. * For male participants, can father children and willing to use an acceptable method of contraception. Female participants who are not of childbearing potential; or male participant not able to father children. * Are capable of giving signed informed consent. Participants will receive either the saRNA vaccine, a licensed Influenza Vaccine (QIV) or a placebo. Participants will not know which vaccine they receive in advance. A placebo does not have any medicine in it but looks just like the study medicine. Participants will receive the study vaccines as a single shot in the arm. We will compare participant experiences to help us determine if the saRNA vaccine is safe and effective. Participants will take part in this study for 6 months. During this time, they will receive the study vaccine and participate in follow-up visits.
NCT07291635
This Phase 1/2 study is intended to assess the safety, tolerability, and immunogenicity of recombinant TVLP in adults 18-64 and 65 years of age and above and to confirm the dose(s) to be developed further in these two age cohorts.
NCT05446740
The purpose of this first-time-in-human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based monovalent vaccine (GSK4382276A) candidate against influenza in healthy younger adults (YA) and older adults (OA).
NCT06094010
This study consists of two parts: Part A Surveillance and Part B Transmission. The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' susceptibility \<12 years with influenza treated with baloxavir marboxil. Part B will include a subset of Part A participants who have household contacts (HHCs) recruited to the study. Part B will evaluate the incidence of onward influenza transmission from pediatric index participants (IPs) under 5 years of age and those aged 5 to under 12 years, treated with baloxavir marboxil, to their HHCs.
NCT05040659
The purpose of this study is to learn more about how to better track smell recovery in people who have been infected with the SARS-CoV-2 virus (which causes COVID-19). Many people who have been infected by this virus develop changes in their sense of smell (olfaction). We are interested in measuring smell function objectively via smell cards that test odor intensity, identification, and discrimination. Objective and precise olfactory testing that can be performed in the convenience of one's home will help identify people with smell loss after infection by SARS-CoV-2. We will use results from this test to better understand the relationship between SARS-CoV-2 infection and recovery of olfactory function and to learn whether the AROMHA longitudinal smell test is a reliable olfactory function tracking tool to quantify smell loss in the context of COVID infection. These results may inform the design of therapeutic clinical trials to accelerate the recovery of smell function.
NCT06668025
This pilot randomized controlled trial (RCT) will investigate the clinical impact of Myxovirus Resistance Protein A (MxA)-guided antiviral treatment versus standard treatment in patients with respiratory viral infections.
NCT06417762
Dime la Verdad (Tell me the truth) will evaluate the use of storytelling by community health workers as a communication strategy to disseminate reliable health information on social media and encourage informed decision-making in favor of recommended immunizations in communities with high morbidity and mortality due to respiratory virus infections. Dime La Verdad is an innovative social media capacity-building program based on theoretical frameworks related to health communication that empowers community health workers to disseminate reliable information about respiratory virus protection strategies through the use of personal narratives on social media. The proposed work will use a rigorous stepped wedge design to 1) deliver a scalable program of science communicators using an adapted curriculum grounded in principles of health communication, 2) evaluate how diffusion of health messaging is perceived on social media, and 3) discern how use of personal narratives to enhance science communication can encourage informed decision-making to promote evidence-based immunization practices and improve health outcomes.
NCT07159763
The purpose of this study is to evaluate how well CD388 works in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, when given as a single dose via 3 subcutaneous (SQ) injections to adult and adolescent participants who are at higher risk of developing influenza complications, and to evaluate the safety and tolerability of CD388, as compared to placebo.
NCT04164212
The purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (LAIV). The investigators will administer LAIV to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure influenza virus and inflammatory/immune responses. In a subset of participants, cystic fibrosis transmembrane conductance regulator (CFTR) function will also be evaluated via measurement of nasal potential difference (NPD)
NCT07421037
The objective of this study was to evaluate the safety of quadrivalent subunit influenza vaccine (adjuvant) in people aged 65 years and older.
NCT05202379
CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts.
NCT06567860
Every 1-2 years, the seasonal influenza vaccine composition changes to include updated viruses, yet the precise effects of updating the vaccine remain understudied. Since the vaccine formulation for each season (with a season defined as starting in July and ending the following June) expires on June 30, vaccine formulations cannot be compared head-to-head. Thus, the 2023 and 2024 vaccines have only been compared by analyzing people given the former vaccine in the fall of 2023 and people given the latter vaccine in the fall of 2024, and baseline repertoires may have greatly changed over the course of that year. To that end, the investigators will vaccinate a cohort with the 2023 influenza vaccine between May-June 2024, in order to compare responses between individuals receiving the 2023 vaccine last fall, the 2023 vaccine late in the season (this cohort), and the 2024 vaccine next fall. The investigators will further assess whether the late-season 2023 vaccine primed this cohort to respond better to the standard 2024 vaccine with standard timing (vaccine administered around September-October).
NCT06160128
The purpose of this study is to comprehensively describe the temporal and geographic utilization of COVID-19 therapies used for mild to moderate disease during different periods of SARS-CoV-2 variant circulation as well as to compare demographic and clinical characteristics of Veterans who are treated or do not receive these different therapies. The investigators will also perform similar descriptive epidemiology for other respiratory viruses, including RSV and influenza and other infectious diseases. This first phase will critically inform feasibility and direction of the second phase, in which the investigators will use target trial emulation design to study the comparative effectiveness of therapies and vaccines for COVID-19, respiratory viruses, including RSV, and influenza, and other infectious diseases.
NCT07396428
The ImpProGUIDE study aims to find out whether implementing new Swiss national guidelines for acute respiratory infections (ARI) can help to reduce antibiotic prescribing in primary care. In Switzerland, most antibiotics are prescribed in outpatient care, and many of these prescriptions may not be needed - especially when infections are caused by viruses, which antibiotics do not treat. Reducing overuse of antibiotics is important to slow the spread of antibiotic resistance. The new guidelines were developed by the Swiss Society for Infectious Diseases (SSI) to support family doctors in managing ARIs, based on a syndromic approach. They recommend the targeted use of point-of-care C-reactive protein (CRP) testing when bacterial infection is suspected, as well as shared decision-making with patients. This study will be carried out in quality circles (QCs) - small groups of family doctors who meet regularly to discuss and improve clinical practice - and in walk-in clinics in French- and Italian-speaking regions of Switzerland. Each will be randomly assigned to either an "intervention" group or a "control" group. In the intervention group, QC moderators and medical center directors will receive implementation resources to lead a session and distribute materials to their group in autumn 2025 on the new guidelines. Doctors can then decide whether or not to use the recommendations in their consultations. In the control group, QCs and centers will continue their regular activities. They will receive access to the same educational materials later, in summer 2026. Throughout the study, the researchers will collect de-identified data from health insurance billing records to track antibiotic prescribing and the use of diagnostic tests. Doctors and QC moderators will also be invited to complete short online surveys twice a year (10-15 minutes) and may be asked to join optional interviews or group discussions after the winter season. The study will also explore the effectiveness of the implementation strategies on the adoption of the SSI guidelines, as well as the barriers and facilitators to adoption. This study type is known as a hybrid effectiveness implementation study, simultaneously evaluating an intervention's impact on antibiotic prescribing and the strategies used to implement the new national guidelines in a real-world setting. Participation in the study is voluntary. Doctors can withdraw at any time. All data will be handled confidentially and in line with Swiss data protection laws. The study is funded by the Swiss National Science Foundation. No support is received from pharmaceutical companies or manufacturers of diagnostic tests.
NCT06602531
The goal of this clinical trial is to evaluate the safety and immune responses of three different dose levels a self-amplifying RNA pandemic influenza vaccine (ARCT-2304) in adults. The key objectives of the study are: * To evaluate safety and reactogenicity of different dose levels of the ARCT-2304 vaccine * To describe the Immune responses of different dose levels of the ARCT-2304 vaccine as measured by hemagglutination inhibition (HAI) and neuraminidase enzyme-linked lectin (ELLA) antibody responses Researchers will compare the results with licensed influenza vaccines to select the most optimal dose level and schedule for vaccine administration in terms of safety and immunogenicity for further development of the vaccine. Participants will receive 2 doses of the ARCT-2304 vaccine or 1 dose of licensed influenza vaccine and 1 dose of placebo. They will be asked: * to complete a daily diary for 7 days after each vaccination, answering questions how they have been feeling on that day. * to provide blood samples at each visit in the clinic * to comply with all study visits and procedures (e.g., be available for planned telephone contacts and unscheduled clinic visits, if required)
NCT06604767
The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.
NCT07357467
This is a follow-up study of a previously completed randomized controlled trial (NCT06827873) that investigated the effects of oral supplements on influenza vaccine response in adults aged 60-70 years. The original study was completed in April 2025, with participants receiving either TUDCA (Tauro Ursodesoxy Cholic Acid) supplementation, fatty acid supplementation, or placebo during influenza vaccination. The primary objectives of this follow-up study are to: 1. Evaluate the durability of vaccine-induced antibody responses approximately 8 months post-vaccination 2. Assess the persistence of immune memory cells, particularly long-lived plasma cells and memory B cells 3. Compare long-term immune responses between the TUDCA supplementation group and placebo group This observational follow-up involves a single visit where participants will: 1. Provide one blood sample for antibody and immune cell analysis 2. No intervention or vaccination will be administered The study will specifically focus on B cell subsets through flow cytometry analysis, including total B cells, memory B cells, plasma cells, and long-lived plasma cells. This research aims to determine whether TUDCA supplementation can enhance the durability of vaccine-induced immunity in older adults.
NCT07310472
The goal of this intervention study is to learn if giving children influenza vaccinations in early childhood education facilities (i.e., daycare) will increase vaccination coverage compared to giving vaccinations only at healthcare. The main question it aims to answer is: • Does offering children nasal influenza vaccine in daycare result in higher proportion of children getting influenza vaccine. Researchers will compare daycare setting and healthcare setting as the location of giving influenza vaccines to children to see if more children will get vaccinated if they have an opportunity to receive nasal influenza vaccine at daycare. Participants in the intervention group will: • Have the opportunity to receive influenza vaccine in the daycare or in the healthcare Participants in the comparison group will: • Have the opportunity to receive influenza vaccine in the healthcare only