Study of high dose/low dose influenza vaccine to effectively stop heart or lung-related problems

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"Does high-dose influenza (“flu”) vaccine safely reduce heart or lung-related problems compared to the standard-dose flu vaccine?"
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
heart failure, heart attack, vaccine
Type:
Biological study, Phase 4
Investigator:
Description
Influenza infection (“the flu”) is known to be associated with a higher risk for heart problems. The purpose of this study is to see if an investigational high-dose influenza (“flu”) vaccine is able to safely reduce heart or lung-related problems compared to the standard-dose flu vaccine. The standard dose vaccine is approved by the Food and Drug Administration (FDA) for protecting against influenza disease caused by influenza A and influenza B viruses. The high dose vaccine is approved by the FDA for the same reason, but only for adults who are at least 65 years old. Thus its use with adults younger than 65 in this study is investigational.
This study requires
Medical history
Blood draws
Vaccine administration
Seven day vaccine diary completion
Follow up contact
Who can participate?
Inclusion Criteria:

- >= 18 years of age

- history of hospitalization for myocardial infarction within 1 year of enrollment OR a history of hospitalization for heart failure within 2 years of enrollment

- At least one of the following additional risk factors:

- Prior MI (if HF the index event above; or a second MI)

- Prior HF hospitalization (if MI the index event above; or a second HF event)

- Age ≥ 65

- LVEF < 40%

- Diabetes mellitus

- Obesity (BMI ≥ 30)

- Renal impairment (eGFR ≤ 60)

- History of ischemic stroke

- History of peripheral artery disease

- Current smoking


Exclusion Criteria:

- Known allergy, hypersensitivity (anaphylaxis), or Guillain-Barré Syndrome within 6 weeks after influenza vaccine

- Any non-cardiac condition that in the opinion of the investigator would lead to life expectancy less than 9 months.

- Receipt of influenza vaccine during current influenza season

- Any illness requiring treatment with antibiotics or anti-inflammatory medication within the past 14 days.

- Any fever over 100 degrees Fahrenheit or 38 degrees Celsius within the past 7 days.
Compensation
$25 per season, for a maximum of up to $75 over 3 seasons.
Payment via a check mailed at the end of each season.
Resources
Schedule
Study duration and period
Direct participation: Up to 3 years Single 90-minute visit first year Single 60- minute visit during years 2 and 3 Three 10-minute follow up contacts over about 1 year (across a flu season). If you choose not to continue receiving vaccinations each year, we will collect hospitalization information from your medical record rather than contacting you. The whole study, outside of the time you will directly participate, is expected to last for 5 years.
Recruitment period
From July 10, 2017
Location
UC Davis Heart and Vascular Services
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Heart Failure
  • Myocardial Infarction

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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