Influenza Vaccine Immune Response in Patients With High-Risk Cardiovascular Disease: A Secondary Analysis of the INVESTED Randomized Clinical Trial
Authors' conclusion
High-dose vaccine elicited a more robust humoral response in patients with heart failure or prior myocardial infarction enrolled in the INVESTED trial, with no association between seroconversion status and the risk for cardiopulmonary hospitalizations or all-cause mortality.
Study context
- Population
- Patients with high-risk CVD (recent acute MI or HF hospitalisation plus ≥1 additional risk factor)of 5260 randomized
- Participants
- 658 patients
- Comparison
- High-dose trivalent vs standard-dose quadrivalent inactivated influenza vaccine
- Primary endpoint
- Mean antibody titer change, seroprotection (titer ≥1:40) and seroconversion (≥4-fold titer increase); association of seroconversion with adverse clinical outcomes
- Follow-up
- 4 weeks
Methodological detailsprespecified, immune response substudy, double-blind, active-controlled, 157 sites in the US and Canada, Hemagglutination inhibition assays at randomization and 4 weeks, 2017-2018 and 2018-2019 seasons
- Prespecified
- Immune response substudy
- Double-blind
- Active-controlled
- 157 sites in the US and Canada
- Hemagglutination inhibition assays at randomization and 4 weeks, 2017-2018 and 2018-2019 seasons
Primary result
As reported in the abstract
Antibody response
Seroprotection achieved for each contained antigen by all participants
>92%
Further findings
Seroconversion for any antigen and risk of cardiopulmonary hospitalisation or all-cause mortality
| HR (95% CI) | P value | ||
|---|---|---|---|
| Seroconversion | 1.09 (0.79–1.53) | P = 0.59 | |
| 0.512Hazard ratio (log scale) |
- Seroconversion for any antigen and risk of cardiopulmonary hospitalisation or all-cause mortality: irrespective of randomized treatment, P = .38 for interaction
Original publication
Influenza Vaccine Immune Response in Patients With High-Risk Cardiovascular Disease: A Secondary Analysis of the INVESTED Randomized Clinical Trial. JAMA Cardiol. Published 1 June 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →