High vs. Standard Dose Influenza Vaccines for Flu
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a high-dose flu vaccine is more effective than a standard-dose vaccine for lung transplant recipients. These individuals face a higher risk of infections, so identifying the best flu vaccine can improve their health. The trial evaluates the effectiveness and safety of each vaccine over multiple flu seasons. It is open to lung transplant recipients who completed an earlier related study, excluding those who have received certain recent treatments or have specific medical histories. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, certain treatments like rituximab or other B-cell depleting therapies must not have been received within 3 months before the first vaccine dose, and T-cell depleting therapies should not have been received between the initial study and this follow-up study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that both high-dose and standard-dose flu vaccines are generally well-tolerated in adults. Research suggests that the high-dose vaccine, often administered to older adults, provides slightly better protection against flu-related hospitalizations and infections. For instance, one study found that 0.56% of people who received the high-dose vaccine were hospitalized for flu or pneumonia, compared to 0.62% of those who received the standard-dose vaccine.
Both vaccines carry a very small risk of Guillain-Barré Syndrome (GBS), a rare condition where the immune system attacks the nerves. However, this risk remains very low, with about 1-2 additional cases per million doses administered.
Most side effects from these vaccines are mild, such as soreness at the injection site or a slight fever. Since this study is in phase 2, there is already some evidence that the treatment is safe for humans, but more information on its safety and effectiveness is still being gathered.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they are exploring whether a high-dose inactivated influenza vaccine can offer better protection against the flu compared to the standard dose vaccine. Unlike the standard flu vaccines, which typically come in a single-dose format, this trial is looking at the effects of administering two doses of both high and standard doses. The high-dose version, in particular, might stimulate a stronger immune response, potentially reducing the severity and duration of flu symptoms, especially in populations more vulnerable to the flu.
What evidence suggests that this trial's treatments could be effective for flu in lung transplant recipients?
This trial will compare the effectiveness of the High Dose Inactivated Influenza Vaccine (HD-IIV) with the Standard Dose Inactivated Influenza Vaccine (SD-IIV). Studies have shown that HD-IIV is more effective than SD-IIV at preventing hospital visits due to the flu. Specifically, one study found that HD-IIV reduced hospitalizations for flu or pneumonia by nearly 9% compared to SD-IIV. Another report indicated that HD-IIV was 11.2% more effective than SD-IIV in reducing flu-related hospital stays. These findings suggest that HD-IIV might offer better protection against serious flu complications. However, the Standard Dose vaccine still provides important protection against the flu, which is crucial for lung transplant patients who are more susceptible to infections.678910
Who Is on the Research Team?
Natahsa Halasa, MD, MPH
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
This trial is for lung transplant recipients at risk of infections due to immunosuppression. Participants must have been part of a previous study comparing high and standard dose flu vaccines at Vanderbilt University Medical Center.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either two doses of HD-IIV or two doses of SD-IIV over two consecutive influenza seasons
Follow-up
Participants are monitored for safety and effectiveness after each vaccination dose
Long-term follow-up
Participants are monitored for long-term safety, including injection-site and systemic reactions, allosensitization, and organ rejection
What Are the Treatments Tested in This Trial?
Interventions
- High Dose Inactivated Influenza Vaccine
- Standard Dose Inactivated Influenza Vaccine
Trial Overview
The study tests if two doses of a high-dose influenza vaccine (HD-IIV) are more effective than the standard dose (SD-IIV) in preventing flu after lung transplants. It's a phase II, randomized, double-blind trial over consecutive flu seasons.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Fluzone: Two Doses of of SD-IIV
Fluzone: Two Doses of HD-IIV
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Citations
High-Dose vs Standard-Dose Influenza Vaccine and ...
Conclusions and Relevance This study found reduced incidence of cardiorespiratory hospitalization among those who received HD-IIV vs SD-IIV, ...
FLUNITY-HD: High-Dose Flu Vaccine Outperforms ...
“Nearly 9% of hospitalisations for influenza or pneumonia were prevented with HD-IIV compared with SD-IIV,” said Johansen, et al. “Importantly, ...
High-dose influenza vaccine in older adults by age and ...
HD-IIV was more effective than SD-IIV for the prevention of influenza-related hospitalizations, with an rVE of 11.2% (7.4%, 14.8%; p<0.001) for all seasons and ...
Interim Estimates of 2024–2025 Seasonal Influenza ...
This report provides interim estimates of effectiveness of any 2024–2025 influenza vaccine (i.e., trivalent inactivated influenza vaccine, ...
High-dose vs. standard-dose inactivated influenza vaccine ...
The aim was to evaluate and compare the relative vaccine effectiveness (rVE) of high-dose (HD-IIV) vs. standard-dose inactivated influenza ...
Influenza (Flu) Vaccine Safety
When there has been an increased risk, it has been in the range of 1-2 additional GBS cases per million flu vaccine doses administered. The data ...
Package Insert - Fluzone High-Dose Quadrivalent
Safety, immunogenicity, and efficacy of Fluzone High-Dose Quadrivalent have been evaluated in adults 65 years of age and older [see Adverse Reactions (6.1) and ...
Immunogenicity and safety of high-dose quadrivalent ...
This study showed that IIV4-HD administered by either intramuscular or subcutaneous injection was well tolerated and highly immunogenic in healthy Japanese ...
Trivalent Influenza Vaccines for Influenza Type A and B
In a randomized controlled trial, Fluzone High-Dose trivalent formulation provided 24% (95% CI: 10-37) better protection against influenza due to any lab- ...
10.
cidrap.umn.edu
cidrap.umn.edu/influenza-vaccines/analyses-high-dose-flu-vaccine-better-protects-against-hospitalization-infectionAnalyses: High-dose flu vaccine better protects against ...
Hospitalization for flu or pneumonia was documented in 0.56% of the HD-IIV group, compared with 0.62% of SD-IIV recipients (relative vaccine ...
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