INVESTED (secondary analysis)
Trial question
What is the role of high-dose trivalent influenza vaccine in patients with high-risk CVD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 658
658 patients (151 female, 507 male).
Inclusion criteria: patients with recent acute MI or HF hospitalization and at least one additional risk factor.
Key exclusion criteria: known allergy, hypersensitivity, or Guillain-Barré syndrome within 6 weeks after influenza vaccine; any non-cardiac condition that would lead to life expectancy < 9 months; receipt of influenza vaccine during current influenza season; any illness requiring treatment with antibiotics or anti-inflammatory medications within the past 14 days.
Interventions
N=322 high-dose trivalent vaccine (containing 60 mcg of hemagglutinin per strain).
N=336 standard-dose quadrivalent vaccine (containing 15 mcg of hemagglutinin per strain).
Primary outcome
Mean improvement in log-titer, A/H2N3 Hong Kong, at 4 weeks
1.8
1.2
1.8
1.4
0.9
0.5
0.0
High-dose trivalent
vaccine
Standard-dose quadrivalent
vaccine
Significant
increase ▲
Significantly greater improvement in mean log-titer, A/H2N3 Hong Kong, at 4 weeks (1.8 vs. 1.2; AD 0.6 , 95% CI 0.3 to 0.9).
Secondary outcomes
Significantly greater improvement in mean log-titer, B/Maryland, at 4 weeks (1.5 vs. 1.2; AD 0.3 , 95% CI 0 to 0.5).
Significant increase in seroconversion at 4 weeks, any antigen (74.6% vs. 65.8%; OR 1.52, 95% CI 1.12 to 2.07).
Safety outcomes
No significant differences in cardiopulmonary hospitalization or all-cause death by seroconversion status (p = 0.59; HR 1.09, 95% CI 0.79-1.53).
Conclusion
In patients with recent acute MI or HF hospitalization and at least one additional risk factor, high-dose trivalent vaccine was superior to standard-dose quadrivalent vaccine with respect to mean improvement in log-titer, A/H2N3 Hong Kong, at 4 weeks.
Reference
Alexander Peikert, Brian L Claggett, Jacob A Udell et al. Influenza Vaccine Immune Response in Patients With High-Risk Cardiovascular Disease: A Secondary Analysis of the INVESTED Randomized Clinical Trial. JAMA Cardiol. 2024 Jun 1;9(6):574-581.
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