Safety, Tolerability, and Immunogenicity of aH5N1 Vaccine in Adults with and Without Underlying Immunosuppressive Conditions
<b>Background</b>: Pandemic influenza may cause substantial morbidity and mortality, especially in older adults and those with immunosuppressive conditions. <b>Methods</b>: In this phase 3, stratified, randomized, controlled, observer-blind, multicenter trial, we evaluated th...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-04-01
|
| Series: | Vaccines |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-393X/13/4/379 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Summary: | <b>Background</b>: Pandemic influenza may cause substantial morbidity and mortality, especially in older adults and those with immunosuppressive conditions. <b>Methods</b>: In this phase 3, stratified, randomized, controlled, observer-blind, multicenter trial, we evaluated the safety, tolerability, and immunogenicity of an adjuvanted H5N1 vaccine (aH5N1) vs. active control (MF59-adjuvanted trivalent seasonal inactivated influenza vaccine [aTIV]) in 539 adults aged 18–60 and ≥61 years. Participants were further stratified into subgroups that were healthy (18–60 years, n = 91; ≥61 years, n = 89) or had prespecified immunosuppressive conditions (18–60 years, n = 180; ≥61 years, n = 179). Antibody responses were measured with microneutralization and single radial hemolysis (SRH) assays. <b>Results</b>: aH5N1 increased antibody responses in healthy persons and those with immunosuppressive conditions in both age groups, with SRH geometric mean ratios (GMRs) > 2.5 and >2.0 in participants aged 18–60 and ≥61 years, respectively, meeting former Committee for Medicinal Products for Human Use (CHMP) criteria. Responses measured with the microneutralization and SRH assays were consistent with previous studies of aH5N1. <b>Conclusions</b>: The aH5N1 vaccine had a clinically acceptable safety and tolerability profile with an AE profile comparable to that observed in previous aH5N1 studies. These findings support the viability of aH5N1 as a pre-pandemic influenza vaccine for the immunization of at-risk individuals when an antigenically matched pandemic influenza vaccine is not yet available. |
|---|---|
| ISSN: | 2076-393X |