CLINICAL TRIAL

High Dose Quadrivalent Inactivated Influenza Vaccine for Communicable Diseases

Waitlist Available · Any Age · All Sexes · Nashville, TN

High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients

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About the trial for Communicable Diseases

Eligible Conditions
Communicable Diseases · Influenza, Human · Immunization; Infection · Flu caused by Influenza · Infections · Transplantation Infection

Treatment Groups

This trial involves 2 different treatments. High Dose Quadrivalent Inactivated Influenza Vaccine is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Standard Dose Quadrivalent Inactivated Influenza Vaccine
BIOLOGICAL
Experimental Group 2
High Dose Quadrivalent Inactivated Influenza Vaccine
BIOLOGICAL

Eligibility

This trial is for patients born any sex of any age. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Lung allograft recipients
Age ≥16 years at time of enrollment
≥1 month and <36 months post-lung transplant
Anticipated to be available for duration of the study
Can be reached by telephone, email, or text message
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 56 (post-vaccination)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 56 (post-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 Quadrivalent Inactivated Influenza Vaccine will improve 2 primary outcomes and 2 secondary outcomes in patients with Communicable Diseases. Measurement will happen over the course of Within 7 days post-vaccination.

The number of participants reporting solicited injection site reactions and systemic reactions.
WITHIN 7 DAYS POST-VACCINATION
Post-vaccination local adverse events (pain, tenderness, swelling/induration, erythema/redness, swelling/induration size, and erythema/redness size) and systemic adverse events (Fatigue/malaise, headache, nausea, body ache/myalgia (not at the injection site), general activity level, vomiting, and fever).
The number of participants achieving seroprotection and seroconversion for influenza virus.
DAY 56 (POST-VACCINATION)
Antibody titers will be measured by hemagglutination inhibition assay. Seroconversion is defined as ≥ 4-fold rise in hemagglutination inhibition assay titers. Seroprotection is defined as ≥1:40 hemagglutination inhibition assay titer.
Geometric Mean Titers of influenza vaccine antibodies.
DAY 56 (POST-VACCINATION)
Antibody titers will be measured by hemagglutination inhibition assay.
Geometric Mean Titers Ratio of influenza vaccine antibodies (post-/pre-vaccination).
DAY 56 (POST-VACCINATION)
Antibody titers will be measured by hemagglutination inhibition assay.

Who is running the study

Principal Investigator
N. H.
Prof. Natasha Halasa, Professor of Pediatric Infectious Diseases
Vanderbilt University Medical Center

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 communicable diseases be cured?

A combination of a focus on prevention and public education, as well as the development of improved diagnostic tools, could help to manage and treat communicable diseases.

Anonymous Patient Answer

What are the signs of communicable diseases?

Fever, cough with or without dyspnoea, fever above 39 degrees C and fatigue with a low white blood cell count are all very suggestive of a communicable disease such as viral pneumonia.

Anonymous Patient Answer

What causes communicable diseases?

Some of these factors appeared to have the greatest impact on the risk of acquiring a noncommunicable disease. It can also be noted that only about half of the risk factors had a significant impact on developing both types of disease. The most important contribution to acquiring a noncommunicable disease was high blood pressure.

Anonymous Patient Answer

What is communicable diseases?

Communicable diseases are diseases spread by a pathogen from one person to another via direct contact or airways. They include respiratory infections. Some of the common diseases are small, short-term infections such as sore throat.\n

Anonymous Patient Answer

What are common treatments for communicable diseases?

Communicable diseases commonly treated include, antibiotics for bacterial infections, hepatitis B vaccinations, vaccination for influenza, measles, chicken pox, and other viral infections. Other treatment options include preventive measures such as pap smears and vaccination.\n\nA significant prevalence of people in the community are treated by the general practitioners for a wide range of ailments, many without even being diagnosed with a disease and with many of the treatments involving undesirable side effects. A substantial group of the patients are either given no treatment at all, or prescribed medication. The overwhelming majority of patients are treated with prescription medication while the patients of the general practitioners are treated with over the counter medication.

Anonymous Patient Answer

How many people get communicable diseases a year in the United States?

Each year, approximately 26 million Americans encounter one or more illnesses brought on by one or more opportunistic pathogens. Communicable diseases represent a leading cause of death in US adults, accounting annually for around 12% of all non-sudden death.

Anonymous Patient Answer

Has high dose quadrivalent inactivated influenza vaccine proven to be more effective than a placebo?

Results from three clinical trials support a benefit in risk of serious complications following vaccination with the quadrivalent inactivated influenza vaccine compared with a placebo. Vaccinating health care workers substantially reduces morbidity from influenza infections.

Anonymous Patient Answer

Does communicable diseases run in families?

Findings from a recent study provides epidemiological evidence that Sudden infant death is closely related to infectious diseases and poor hygiene. The high prevalence of many pathogens and the relationship between exposure to microbes and sudden infant death warrants further investigation of factors contributing to early death from pathogens.

Anonymous Patient Answer

Does high dose quadrivalent inactivated influenza vaccine improve quality of life for those with communicable diseases?

There were no differences in [QOL] change between patients with CAD and those without CAD, but higher doses of IDOIV were associated with higher QOL improvements. These data support the hypothesis that IDOIV might be useful for reducing [QOL] changes in a subgroup of patients with CAD. Future studies seem warranted in larger samples with greater statistical power and including other aspects of [QOL] improvement.

Anonymous Patient Answer

Is high dose quadrivalent inactivated influenza vaccine safe for people?

quadrivalent quad-T of inactivated H1N1 influenza vaccine was well tolerated in adults at a dose of 500-650 µg and showed comparable immunogenicity to a standard dose of inactivated H1N1 influenza vaccine.

Anonymous Patient Answer

Who should consider clinical trials for communicable diseases?

Despite the large number of trials involving patients with chronic conditions, few trials focused on patients with communicable diseases. When considering this important unmet need, the results of RCTs should be considered with caution, and the limitations of single-center (and probably biased) studies should be considered before adopting them as evidence base for clinical treatment in the absence of evidence from network meta-analyses and other well-designed trials.

Anonymous Patient Answer

What is the average age someone gets communicable diseases?

There is no consensus on the timing, duration or frequency of health interventions aiming at preventing communicable diseases; most of these interventions are aimed at children and teenagers. For adults, it is recommended that age-appropriate screening and treatment of adults who are sexually active should be an important priority for individualized preventive programs that target high-risk groups.

Anonymous Patient Answer
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