Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes

NCT ID: NCT04001504

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1801 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-19
• Study Completion Date: 2022-08-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Double Dose Quadrivalent Influenza Vaccine

Double Dose QIV during index ACS hospitalization

Group Type: EXPERIMENTAL

Double Dose Quadrivalent Influenza Vaccine

Intervention Type: BIOLOGICAL

Double Dose QIV (30µg Hemagglutinin)

Standard Dose Quadrivalent Influenza Vaccine

Standard Dose QIV 30 days after randomization

Group Type: ACTIVE_COMPARATOR

Standard Dose Quadrivalent Influenza Vaccine

Intervention Type: BIOLOGICAL

Standard Dose QIV (15µg Hemagglutinin)

Interventions

Double Dose Quadrivalent Influenza Vaccine

Double Dose QIV (30µg Hemagglutinin)

Intervention Type: BIOLOGICAL

Standard Dose Quadrivalent Influenza Vaccine

Standard Dose QIV (15µg Hemagglutinin)

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Otávio Berwanger, MD-PhD

Role: STUDY_CHAIR

Academic Research Organization -- Hospital Israelita Albert Einstein

Henrique A Fonseca, PhD

Role: PRINCIPAL_INVESTIGATOR

Academic Research Organization -- Hospital Israelita Albert Einstein

Locations

Universidade Federal do Ceará / Hospital Universitário Walter Cantídio

Fortaleza, Ceará, Brazil

Hospital e Clínica São Roque

Ipiaú, Estado de Bahia, Brazil

Hospital Ana Nery

Salvador, Estado de Bahia, Brazil

Hospital Cárdio Pulmonar

Salvador, Estado de Bahia, Brazil

Instituto de Cardiologia do Distrito Federal

Brasília, Federal District, Brazil

Hospital Universitário Ciências Médicas

Belo Horizonte, Minas Gerais, Brazil

Hospital Santa Lucia

Poços de Caldas, Minas Gerais, Brazil

Hospital Universitario da Universidade Estadual de Londrina

Londrina, Paraná, Brazil

Hospital Agamenon Magalhães

Recife, Pernambuco, Brazil

Pronto Socorro Cardiológico de Pernambuco

Recife, Pernambuco, Brazil

Instituto Estadual de Cardiologia Aloysio de Castro

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

IPEMI - Instituto de Pesquisas Médicas de Itajaí

Itajaí, Santa Catarina, Brazil

Hospital Dona Helena

Joinville, Santa Catarina, Brazil

Hospital Regional Hans Dieter Schmidt

Joinville, Santa Catarina, Brazil

Centro de Pesquisa Clinica do Coração

Aracaju, Sergipe, Brazil

Faculdade de Medicina de Botucatu - UNESP

Botucatu, São Paulo, Brazil

Irmandade da Santa Casa de Misericórdia de Marília

Marília, São Paulo, Brazil

Santa Casa de Misericórdia de Presidente Prudente

Presidente Prudente, São Paulo, Brazil

Instituto do Coração - HC FMUSP

São Paulo, São Paulo, Brazil

Instituto Dante Pazzanese

São Paulo, , Brazil

Countries

Brazil

References

Fonseca HAR, Sampaio Silva G, Monfardini F, Nicolau JC, Rizzo LV, Berwanger O. Influenza vaccination for prevention of death and major cardiovascular events in patients with a history of stroke: A subanalysis of the VIP-ACS trial. Int J Stroke. 2025 Sep 19:17474930251383626. doi: 10.1177/17474930251383626. Online ahead of print.

Reference Type: DERIVED

PMID: 40973981 (View on PubMed)

Fonseca HAR, Zimerman A, Monfardini F, Guimaraes HP, Pedrosa RP, Patriota RLS, Couto Patriota TLG, Passos LCS, Dall'Orto FTC, Hoffmann Filho CR, Nascimento BR, Baldissera FA, Pereira CAC, Caramori PRA, Andrade PB, Okoshi MP, Polanczyk CA, Silveira FS, Villacorta AS, Nicolau JC, Rizzo LV, Berwanger O; VIP-ACS team. In-Hospital influenza vaccination to prevent cardiorespiratory events in the first 45 days after acute coronary syndrome: A prespecified analysis of the VIP-ACS trial. Vaccine. 2024 Jan 25;42(3):496-504. doi: 10.1016/j.vaccine.2023.12.074. Epub 2023 Dec 27.

Reference Type: DERIVED

PMID: 38154990 (View on PubMed)

Fonseca HAR, Furtado RHM, Zimerman A, Lemos PA, Franken M, Monfardini F, Pedrosa RP, Patriota RLS, Passos LCS, Dall'Orto FTC, Hoffmann Filho CR, Nascimento BR, Baldissera FA, Pereira CAC, Caramori PRA, de Andrade PB, Esteves C, Salim EF, da Silva JH, Pedro IC, Silva MCR, de Pedri EH, Carioca ACRD, de Piano LPA, Albuquerque CSN, Moia DDF, Momesso RGRAP, Machado FP, Damiani LP, Soares RVP, Schettino GP, Rizzo LV, Nicolau JC, Berwanger O. Influenza vaccination strategy in acute coronary syndromes: the VIP-ACS trial. Eur Heart J. 2022 Nov 1;43(41):4378-4388. doi: 10.1093/eurheartj/ehac472.

Reference Type: DERIVED

PMID: 36030400 (View on PubMed)

Other Identifiers

VIP-ACS trial

Identifier Type: -

Identifier Source: org_study_id