NCT04001504: VIP-ACS

Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes

Completed Phase 3 Last updated 31 August 2022

What this trial tests

Phase 3 trial testing Double Dose Quadrivalent Influenza Vaccine in Acute Coronary Syndrome in 1,801 participants. Completed in 28 August 2022.

Timeline

19 July 2019

Primary endpoint
28 August 2022

28 August 2022

Quick facts

Lead sponsor	Hospital Israelita Albert Einstein
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1,801
Start date	19 July 2019
Primary completion	28 August 2022
Estimated completion	28 August 2022
Sites	22 locations across Brazil

Drugs / interventions tested

• Double Dose Quadrivalent Influenza Vaccine — full drug profile →
• Standard Dose Quadrivalent Influenza Vaccine — full drug profile →

Conditions studied

• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →

Sponsor

Hospital Israelita Albert Einstein

Who can join

18 and older, any sex, with Acute Coronary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Influenza vaccination strategy in acute coronary syndromes: the VIP-ACS trial.
   Fonseca HAR, Furtado RHM, Zimerman A, Lemos PA, et al · · 2022 · cited 16× · PMID 36030400 · DOI 10.1093/eurheartj/ehac472
2. Win Ratio Analyses of Piperacillin-Tazobactam Versus Meropenem for Ceftriaxone-Nonsusceptible Escherichia coli or Klebsiella pneumoniae Bloodstream Infections: Post Hoc Insights From the MERINO Trial.
   Hardy M, Harris PNA, Paterson DL, Chatfield MD, et al · · 2024 · cited 10× · PMID 38306577 · DOI 10.1093/cid/ciae050
3. COVID-19 Vaccination and Cardiopulmonary Events After Acute Coronary Syndromes: A Secondary Analysis of a Randomized Clinical Trial.
   Fonseca HAR, Damiani LP, Monfardini F, Zimerman A, et al · · 2024 · cited 1× · PMID 38814645 · DOI 10.1001/jamanetworkopen.2024.13946
4. Generalizing the Finkelstein-Schoenfeld Test to Incorporate Multiple Alternating Thresholds.
   Mou Y, Kyriakides T, Hummel S, Li F, et al · · 2026 · PMID 41761447 · DOI 10.1002/bimj.70117
5. Influenza vaccination for prevention of death and major cardiovascular events in patients with a history of stroke: A subanalysis of the VIP-ACS trial.
   Fonseca HAR, Sampaio Silva G, Monfardini F, Nicolau JC, et al · · 2026 · PMID 40973981 · DOI 10.1177/17474930251383626