Flu Vaccine for Immune Deficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how opioid use affects the body's response to the flu vaccine, particularly in individuals with HIV. Participants will receive the Fluzone Quadrivalent flu vaccine and will be grouped based on their HIV status and opioid use. The trial suits those who have used opioids for at least 90 days or have not used them in the past year, and either have HIV and are undergoing treatment or have tested negative for HIV. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research seeks to understand how it benefits a broader range of patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are using opioids, you must continue using them for 4 weeks after the flu vaccination. Participants cannot be on steroids or other immune-affecting medications.
What is the safety track record for these treatments?
Research shows that the Fluzone Quadrivalent flu vaccine is generally safe. Past studies found that most side effects were mild, such as soreness at the injection site, occasional fever, or muscle aches. These reactions are common with most vaccines and typically resolve on their own.
Opioids often manage pain but carry risks, especially with prolonged or improper use. Side effects can include drowsiness, nausea, and constipation. Following the doctor's instructions carefully when using opioids is crucial.
Most people tolerate the flu vaccine well, and understanding how opioids might affect the immune system is a primary goal of the study. Always consult a healthcare provider about any concerns before joining a trial.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the flu vaccine trial for individuals with immune deficiencies because it explores how well the Fluzone Quadrivalent vaccine works in different groups, particularly those with HIV and/or opioid use. Unlike standard flu vaccines, this trial specifically examines the vaccine's effectiveness in people who are often overlooked in vaccine studies, like those with compromised immune systems or who use opioids. By including these diverse groups, the trial aims to uncover whether the vaccine provides adequate protection and if there are any unique responses or benefits. This could lead to better-targeted flu prevention strategies for vulnerable populations.
What evidence suggests that this trial's treatments could be effective for immune responses to the flu vaccine?
Studies have shown that the Fluzone Quadrivalent flu vaccine works well for people with HIV. A large study involving over 30,000 HIV patients found that the vaccine did not harm their health, including important immune system markers like CD4 counts. This indicates that the vaccine did not worsen their condition and helped protect them from the flu. In this trial, participants will receive the Fluzone Quadrivalent vaccine, with separate groups for HIV-positive and HIV-negative individuals, as well as opioid users and non-users. The vaccine is also safe and effective for other groups, including children. Flu vaccines like Fluzone help the body build immunity, reducing the likelihood of getting sick from the flu. Overall, Fluzone Quadrivalent is a good choice for anyone wanting to protect themselves from the flu, including those with immune system challenges.678910
Who Is on the Research Team?
Savita Pahwa, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 who use opioids and those with or without HIV. Opioid users must have been using for at least 90 days and agree to continue during the study. HIV+ individuals need controlled viral loads, be on ART for a year, and have CD4 counts over 200/mm3. Participants can't join if they've had this season's flu shot, can't consent, are allergic to vaccine components, or have certain health conditions like diabetes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive flu vaccination and continue standard of care antiretroviral therapy (ART) if applicable
Follow-up
Participants are monitored for immune response and antibody levels
What Are the Treatments Tested in This Trial?
Interventions
- Fluzone Quadrivalent
- Opioid
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor