Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes (VIP-ACS)

Hospital Israelita Albert Einstein

Status and phase: Completed; Phase 3

Conditions: Acute Coronary Syndrome

Treatments: Biological: Standard Dose Quadrivalent Influenza Vaccine; Biological: Double Dose Quadrivalent Influenza Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT04001504

VIP-ACS trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,801 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age >= 18 years and older
• Acute coronary syndrome in hospital phase.

Exclusion Criteria:

• Participation in another clinical trial with vaccines;
• Refusal to provide consent;
• Hypersensitivity and/or anaphylaxis to any component of the vaccine, or Guillain-Barré within 6 weeks after previous influenza vaccine;
• Have already received the influenza vaccine with the same strains used in the study within the last 12 months of inclusion in the study
• Breastfeeding women;
• Pregnant women;
• Presenting an acute coronary syndrome during months of December, January, and February.
• Acute coronary syndrome hospitalization >7 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,801 participants in 2 patient groups

Double Dose Quadrivalent Influenza Vaccine

Experimental group

Description:

Double Dose QIV during index ACS hospitalization

Treatment:

Biological: Double Dose Quadrivalent Influenza Vaccine

Standard Dose Quadrivalent Influenza Vaccine

Active Comparator group

Description:

Standard Dose QIV 30 days after randomization

Treatment:

Biological: Standard Dose Quadrivalent Influenza Vaccine