High dose influenza vaccination for Influenza, Human
This study is evaluating whether HIV infection affects the immune system's response to the flu vaccine.
See full descriptionAbout the trial for Influenza, Human
Treatment Groups
This trial involves 4 different treatments. High Dose Influenza Vaccination is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether High dose influenza vaccination will improve 3 primary outcomes and 4 secondary outcomes in patients with Influenza, Human. Measurement will happen over the course of Month 13 (1 month post high-dose flu vaccination).
Who is running the study
Principal InvestigatorPatient Q & A Section
Can influenza, human be cured?
Influenza, human does not have a cure. Influenza can only be controlled through vaccination. If influenza does not go away, the same vaccine that is used to make vaccine, will be of help in an influenza outbreak.
What causes influenza, human?
Influenza is caused by a virus most commonly transmitted through airborne droplets. Symptoms tend to present after a 4-day incubation period, and usually last 2-3 days. Most people resolve at that time, but 5% will be hospitalized. The average number of influenza-related deaths per year is about 1.2million.
What are the signs of influenza, human?
Symptoms of [influenza](https://www.withpower.com/clinical-trials/influenza) and signs and symptoms of pneumonia may be similar, thus delaying diagnosis and treatment. The severity of influenza does not influence progression from influenza to pneumonia. If pneumonia is present without influenza, it is usually caused by other conditions, such as bacterial pneumonia or a lung cancer. Patients with lung cancer should be screened for influenza. If a patient with pneumonia is taking neuraminidase inhibitors, influenza may be misdiagnosed as pneumonia caused by influenza because the clinical overlap of flu and pneumonia is common.
How many people get influenza, human a year in the United States?
Influenza affects more people in the United States annually (3.7 million infected) than any other pathogen in the United States. This represents 1.02% of the country's total population.
What are common treatments for influenza, human?
Most influenza infections can be effectively treated with non-specific over-the-counter antipyretics and analgesics in the emergency department (ED). However, in severely ill children, antiviral medications such as amantadine and rimantadine have been approved by the FDA to be used to prevent the emergence and spread of oseltamivir-resistant influenza strains. These medications have been shown to shorten the duration and decrease the severity of symptoms. Severe cases may require hospital treatment. However, the safety and effectiveness of these drugs as well as possible effectiveness against oseltamivir-resistant strains are unknown. Additionally, influenza-specific treatment may not be available in the ED.
What are the common side effects of high dose influenza vaccination?
Vaccinically induced adverse events may not be uncommon when immunity to common viral antigens is deficient. These observations should be taken into account during vaccination planning of high-risk individuals.
How does high dose influenza vaccination work?
High dose influenza vaccines work efficiently in healthy adults and children. In the post immunisation period, they were well tolerated and elicited high immune responses. Moreover they significantly decreased viral replication. Therefore, in a non-proprietary context, the clinical use of the high doses of influenza vaccine with enhanced immunogenicity is recommended. Vaccination is also recommended at workplaces because of possible exposure in the workplace to the virus.
What is the latest research for influenza, human?
There are many benefits to the prevention of [influenza](https://www.withpower.com/clinical-tri[als](https://www.withpower.com/clinical-trials/als)/influenza) from vaccinations; for instance an estimated 49 million lives spent in unnecessary treatment are avoided. The influenza vaccine is usually recommended for adults who are at the highest risk of disease and who are also at the highest risk of death (for instance children under the age of 2 and the elderly). The influenza season typically begins around midwinter and ends at the beginning of spring, however, the exact start and end dates may vary with individual physicians. Patients can check whether their physician's practice has an updated recommendation for a flu vaccine by looking for a recommendation in their electronic medical record.
What does high dose influenza vaccination usually treat?
Patients hospitalized for a flu-like illness are usually treated empirically, which has led to widespread overuse of oseltamivir. To decrease this rate, patients might be hospitalized and monitored if warranted by local health care team recommendations. When this happens, patients can be safely discharged within 24hours of positive test results from rapid diagnostic tests, or 48hours after other patients have been discharged.
Who should consider clinical trials for influenza, human?
A multidisciplinary review of the evidence of cost-effectiveness of influenza antiviral treatment led to the conclusions that for influenza A, patients that can benefit from treatment with antivirals or vaccination are those under age 50 who require treatment to prevent complications of influenza infection or with comorbidities (e.g., asthma, coronary heart disease). Patients with chronic underlying ailments (e.g., chronic lung or liver disease) should receive vaccination for influenza. The decision of whether to seek treatment as part of influenza antiviral treatment should be made by healthcare providers working to prevent complications of infection and/or manage patients with underlying illness. For influenza B infection, the patient should be counseled about the risks (e.g.
What are the latest developments in high dose influenza vaccination for therapeutic use?
Recent advances in our understanding of the mechanism of action of the antiviral drug amantadine and our knowledge of the role played by the immune system in influenza infection means that therapeutic influenza vaccination could evolve into a more robust and sustained therapeutic treatment of infection during and after the acute phase of infection when antiviral treatment is not possible. Current recommendations to use amantadine when influenza viruses are highly pathogenic to prevent hospitalization due to complications and as a first line of defense against influenza infections for all children less than six years of age are not appropriate and should be abandoned because the antiviral activity of amantadine may not be sufficient in order to prevent the development of the disease.