NCT04001504

Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes

Evaluation of the Effectiveness of Double Dose Influenza Vaccination to Reduce Major Cardiovascular Events After an Acute Coronary Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,801 (actual)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cardiovascular disease has a great burden in the context of public health, as well as the low pharmacological adherence of patients who have chronic non-transmissible diseases. However, the investigators do not have data on the efficacy of vaccination to reduce cardiovascular events in the acute coronary syndromes, and the few studies evaluating the cardioprotective potential of the influenza vaccine were conducted in countries with well defined seasonalities, divergent of Brazil, that presents a constant viral circulation during all months of the year and distinct among its regions. Therefore, study evaluating higher dose vaccination in a period that contemplates the seasonality of the influenza virus in Brazil may bring important findings to different scientific gaps, as well as clarify questions about the possible benefit of doubled vaccination - which does not present contraindications - immediately after a atherothrombotic event. If it shows real benefit, it could also be a future therapeutic tool adjuvant to traditional drug therapy in the prevention of cardiovascular events.

Detailed description

Phase III, randomized, controlled, multicenter, open-label, superiority, 1:1 allocation, blind assessment of clinical outcomes and intention-to-treat analysis clinical trial to determine whether increased doses(double dose) of influenza vaccine in the hospital phase, when compared to usual dose vaccination (30 days of randomization), decreases the risk of cardiovascular and respiratory events. Hospitalizations due to COVID-19 are excluded from the respiratory infection component of the primary outcome.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Double Dose Quadrivalent Influenza Vaccine	Double Dose QIV (30µg Hemagglutinin)
BIOLOGICAL	Standard Dose Quadrivalent Influenza Vaccine	Standard Dose QIV (15µg Hemagglutinin)

Timeline

• Start date: 2019-07-19
• Primary completion: 2022-08-28
• Completion: 2022-08-28
• First posted: 2019-06-28
• Last updated: 2022-08-31

Locations

22 sites across 1 country: Brazil