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Influenza Vaccination for HIV-Related Immune Response
Study Summary
This trial will compare blood samples from HIV+ and HIV- people to see how well their immune systems respond to the flu vaccine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 6104 Patients • NCT01346592Trial Design
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Who is running the clinical trial?
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- I am HIV positive, on treatment for over a year, with a CD4 count over 200 and an undetectable viral load.You can't get the flu shot, don't take your HIV medication regularly, can't understand what the study is about, already got the flu shot this year, or have a history of drug abuse, including cocaine.
- Group 1: Young HIV negative group
- Group 2: Young HIV positive group
- Group 3: Old HIV positive group
- Group 4: Old HIV negative group
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there still availability to join the trial?
"The trial is still open for recruitment, with the initial posting date being October 30th 2020 and its most recent edit occurring on October 17th 2022 according to clinicaltrials.gov."
Are there any past experiments involving the application of high dose influenza vaccinations?
"Currently, 14 studies are being conducted to assess the efficacy of high dose influenza vaccination. Of these trials, one is currently in phase 3. While many of them are happening in Miami, Florida, 15 separate sites across the country have opened up clinical trial opportunities on this matter."
Has this research ever been conducted before?
"The study of High dose influenza vaccination began in 2016 under the sponsorship of Pharmacyclics LLC. After a successful Phase 1 trial involving 42 people, it was approved for further research in Phase 2. As we speak 14 trials are currently being conducted across 10 cities and 3 countries."
Has the FDA authorized the use of high-potency influenza vaccinations?
"High dose influenza vaccination is a Phase 4 intervention, with approval from the relevant authorities. Therefore, our team at Power has assigned it a safety score of 3 on their scale."
How many participants are included in this research project?
"Affirmative, clinicaltrials.gov records show that the trial is actively recruiting participants and was first posted on October 30th 2020. As of October 17th 2022, 400 patients will be admitted through 1 medical centre."
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