CLINICAL TRIAL

High dose influenza vaccination for Influenza, Human

Recruiting · 18+ · All Sexes · Miami, FL

This study is evaluating whether HIV infection affects the immune system's response to the flu vaccine.

See full description

About 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.

Experimental Group 1
High dose influenza vaccination
BIOLOGICAL
+
Standard dose influenza vaccination
BIOLOGICAL
Experimental Group 2
High dose influenza vaccination
BIOLOGICAL
+
Standard dose influenza vaccination
BIOLOGICAL
Experimental Group 3
High dose influenza vaccination
BIOLOGICAL
+
Standard dose influenza vaccination
BIOLOGICAL
Show More

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
HIV infection, as documented by any licensed ELISA test kit. Participants on ART as a result of prior HIV documented infection will not be required to provide proof of diagnosis of HIV infection.
Additional criteria for HIV positive
on ART for at least 1 year. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment
Cluster of differentiation 4 (CD4) count available in the prior 6 months and >200/mm3
Undetectable viral load (< 40 copies/mL). Blips of <1000 copies/mL will be allowed.
Documented negative HIV test at the time of study entry, either by any licensed ELISA.
Individuals age: ≤35 years and ≥65 years.
No history of other immunodeficiency disorders
Not on steroid or other immunosuppressive/immunomodulators medications.
No active malignancies.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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).

Percentage of monocytes
MONTH 13 (1 MONTH POST HIGH-DOSE FLU VACCINATION)
Percentage of monocytes as measured using peripheral blood samples
MONTH 13 (1 MONTH POST HIGH-DOSE FLU VACCINATION)
Percentage of T-follicular helper (Tfh) cells
MONTH 13 (1 MONTH POST HIGH-DOSE FLU VACCINATION)
Percentage of Tfh cells as measured using peripheral blood samples
MONTH 13 (1 MONTH POST HIGH-DOSE FLU VACCINATION)
Percentage of Participants with Vaccine Response
MONTH 13 (1 MONTH POST HIGH-DOSE FLU VACCINATION)
Percentage of participants that are vaccine responders and non-responders will be reported. Response is evaluated using seroconversion to the flu vaccine using serum sample.
MONTH 13 (1 MONTH POST HIGH-DOSE FLU VACCINATION)
Percentage of Tfh cells producing cytokines
MONTH 13 (1 MONTH POST HIGH-DOSE FLU VACCINATION)
Percentage of Tfh cells producing cytokines as measured using peripheral blood samples
MONTH 13 (1 MONTH POST HIGH-DOSE FLU VACCINATION)
Percentage of B cells
MONTH 13 (1 MONTH POST HIGH-DOSE FLU VACCINATION)
Percentage of B cells as measured using peripheral blood samples
MONTH 13 (1 MONTH POST HIGH-DOSE FLU VACCINATION)
Change in neutralization antibody response
BASELINE TO MONTH 6 (POST STANDARD DOSE FLU VACCINATION), BASELINE TO MONTH 18 (POST HIGH-DOSE FLU VACCINATION)
Change in mean titers of neutralization antibody response will be measured using serum sample.
BASELINE TO MONTH 6 (POST STANDARD DOSE FLU VACCINATION), BASELINE TO MONTH 18 (POST HIGH-DOSE FLU VACCINATION)
See More

Who is running the study

Principal Investigator
S. P.
Prof. Savita Pahwa, Professor
University of Miami

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

What is influenza, human?

This paper discusses the epidemiology and clinical manifestations of influenza. To help you get prepared for possible influenza outbreaks, an overview of the disease mechanisms and prevention measures is provided.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Influenza, Human by sharing your contact details with the study coordinator.