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Several reasons contribute to the seasonal influenza vaccine's effectiveness: antigenic shifts, slow manufacturing processing, vaccine strain egg-adapted modifications, short duration of protection, lack of cross-reactivity, and poor immunogenicity in some populations are all limiting factors. Influenza challenge models can be helpful as such. Human challenge models have many advantages over traditional models that can advance scientific knowledge of influenza disease, influenza vaccine safety, and influenza therapy's benefits. Ultimately, influenza challenge model findings may be able to reduce influenza morbidity and mortality associated with influenza. Human challenge studies for influenza are a particularly promising method for the creation of a universal influenza vaccine. A universal flu vaccine would be at least 75% safe, keep control for at least one year, guard against group I and II influenza A virus strains, and be safe for all age groups, according to the National Institute of Allergy and Infectious Diseases' strategic plan, and be safe for all age groups. A human challenge model could also help determine correlates of influenza risk, identify genes of immunity, and compare different universal influenza vaccine vendors, according to the strategic plan. This research aims to conduct a human challenge research to validate the influenza challenge model at Emory University and help identify influenza pathogenesis, immunity, transmission, and evolution. Using a recently validated influenza challenge model with influenza A H3N2 strain, up to ten healthy subjects will be tested.
Source link: https://clinicaltrials.gov/ct2/show/NCT05332899
The impact of influenza on the increasing number of patients who are immunocompromised as a result of acute and chronic diseases as well as immunosuppressive drugs is largely unknown. In comparison to those in normal hosts, limited information regarding influenza's natural immune response and how chronic illness and immunosuppression may have a dramatic effect on the immune response to the virus. Both normal and immunocompromised patients' responses as well as what steps can be taken to better protect or treat patients during the emergence of a new pandemic.
Source link: https://clinicaltrials.gov/ct2/show/NCT00533182
Vaccination is a common public health measure for lowering morbidity and mortality from influenza worldwide. From the third trimester to fourth years old, medical records review will occur, as well as medical examination to determine outcomes not captured by weekly illness and respiratory surveillance, as well as medical record review up to 18 years old. For at least three entire flu seasons, the primary aim is to rigorously document the natural history of infection and immune response to influenza in study infants.
Source link: https://clinicaltrials.gov/ct2/show/NCT05436184
Bordetella pertussis-related respiratory disease causes pertussis, Pertussis is a bacterial respiratory infection. Since 2004, France has introduced the cocooning scheme, which includes vaccinating people likely to be in close proximity with the child during this time, in order to safeguard infants under the age of 6 months. During breastfeeding, vaccination against pertussis is not currently recommended in France. Influenza is a viral respiratory disease caused by Myxovirus influenzae, which is highly infectious. Regardless of the trimester of pregnancy, pregnant women in France are urged to get influenza vaccines against influenza. In France, there are no new studies on influenza and pertussis vaccination coverage among pregnant or postpartum women. Knowing the current status of vaccination coverage among pregnant women and caregivers, their knowledge, and fears regarding vaccination could help with the accuracy provided by healthcare professionals.
Source link: https://clinicaltrials.gov/ct2/show/NCT05234229
Until the immune system is challenged, certain functions of the immune system are only revealed. When a person is vaccinated, a coordinated response occurs: activation and coordination of multiple innate and adaptive immune cell populations and pathways, culminating in the establishment of germinal centers from which antibody-producing plasma cells and memory B cells derive. We can obtain a comprehensive picture of how the immune system responds to a vaccine challenge by taking measurements at various time points before and after vaccination. This is an open-label, prospective, exploratory study designed to determine the baseline and post-vaccination immune responses of healthy volunteers to an approved seasonal influenza vaccine. On day -7 and 0 of the study vaccine, subjects will receive baseline blood samples before receiving the study vaccine. The aim of this program is to use the collective data obtained among all healthy volunteers to determine how the immune system functions as a whole.
Source link: https://clinicaltrials.gov/ct2/show/NCT04025580
The two most common causes of severe viral respiratory tract infections in humans are Influenza and Respiratory Syncytial Virus. Seasonal influenza has an annual incidence of ten-20 percent per annum with frequent complications, and annual mortality in the United States has been estimated at 9. 9 deaths per 100,000. According to the World Health Organization, RSV causes 64 million infections per annum and 160,000 deaths per annum. It is the leading cause of acute respiratory disease in young children and is also a significant problem among pregnant women in whom RSV is responsible for around 22% of winter respiratory illnesses with a case fatality rate of 2-8%. The investigators will analyze the response to infection in healthy adult volunteers using previously described Good Manufacturing Practices-certified RSV and influenza viruses derived from new clinical isolates. Immune correlates of immunity defense against infection or symptomatic disease can therefore be inferred by the investigators.
Source link: https://clinicaltrials.gov/ct2/show/NCT02755948
In pediatric hematopoietic stem cell transplant recipients, it will be important to determine whether high-dose trivalent inactivated influenza vaccine, >= 1:40 HAI titer, or higher geometric mean titer to influenza A antigens will increase the likelihood of achieving a > 4-fold rise in hemagglutination titers, >= 1:40 HAI titer, or higher geometric mean titer to influenza A antigen t In pediatric HSCT recipients, a greater risk of seeing a >= 4-fold rise in HAI titers, > = 1:40 HAI titer, or higher GMT titers to influenza B antigens would increase the likelihood of seeing a >= 4-fold rise in HAI titers, or higher GMT titers to influenza B antigens. In pediatric HSCT recipients receiving either HD-TIV or standard dose QIV, we explore the correlation between HAI titers, in vivo T and B cell phenotype, and in vitro influenza-specific T and B cell responses. Patients are given a standard dose QIV IM on day 0 and day 28.
Source link: https://clinicaltrials.gov/ct2/show/NCT02860039
During the study, participants will be inoculated with 1 dose of challenge virus during the study and then followed for a minimum of nine weeks after inoculation. Determine the right dose of A/Mallard/Ohio/99/1989 H10N7 human challenge virus that causes MMID in at least 60% of healthy volunteers or determine the incidence of MMID at the highest dose of 107 50% Tissue Culture Infective Dose. MMID, which is a positive U. S. Food and Drug Administration approved clinical test for influenza plus one or two influenza symptoms, is a common cause of MMID. Secondary Endpoints: Daily and total scores on FLU-PRO questionnaire in each participant Determined number and duration of symptoms and signs elicited by daily oral history and clinical examination Duration and type of influenza shedding in nasal wash/SAM by quantitative real-time polymerase chain reaction, respectively. Endpoints of Exploratory Endpoints: Human gene expression was determined by gene expression analysis and high-throughput sequencing of influenza infection-induced gene expression by human gene expression analysis and high-throughput sequencing.
Source link: https://clinicaltrials.gov/ct2/show/NCT05436444
While adults are heavily involved in influenza vaccination studies, there are no studies in the pediatric population.
Source link: https://clinicaltrials.gov/ct2/show/NCT04963166
Circulating anti-influenza antibodies are a key factor in predicting clinical disease and severity among those infected with influenza. Specifically designed antibodies against influenza include antibodies against hemagglutininin and neuraminidase. Individuals may be infected multiple times with the same strain of influenza A, as well as with the same strain. The acute infection period has been solely focused on the acute infection period up to two months after initial infection in our previous challenge studies. The challenge setting gives us the unique ability to track individuals from a specific, well-defined, and well-known illness, as well as long-term changes in antibody titers from a pre-exposure baseline. We will track individuals who have undergone influenza challenge or who have been simply infected with influenza to see changes in anti-influenza antibody titers over a two-year period in this natural history research.
Source link: https://clinicaltrials.gov/ct2/show/NCT02511002
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