tetano
Editor, Senior Moderator
Vaccines (Basel)
. 2024 Apr 30;12(5):481.
doi: 10.3390/vaccines12050481. Safety, Tolerability, and Immunogenicity of aH5N1 Vaccine in Adults with and without Underlying Medical Conditions
Tomas Jelinek[SUP] 1 [/SUP], Tino F Schwarz[SUP] 2 [/SUP], Emil Reisinger[SUP] 3 [/SUP], Peter Malfertheiner[SUP] 4 [/SUP], Eve Versage[SUP] 5 [/SUP], Esther Van Twuijver[SUP] 6 [/SUP], Matthew Hohenboken[SUP] 5 [/SUP]
Affiliations
Influenza pandemics pose a serious risk to the global population, with the potential for high morbidity and mortality. An adjuvanted H5N1 vaccine (aH5N1) has been approved for prophylaxis against the avian influenza virus H5N1, which is a likely cause of future pandemics. In this phase-III, stratified, randomized, controlled, observer-blind, multicenter study, we evaluated the safety and immunogenicity of aH5N1 in four separate groups of adults: adults 18-60 years of age who were healthy or had high-risk medical conditions and older adults ≥61 years of age who were healthy or had high-risk medical conditions. Subjects were randomly assigned to aH5N1 or the comparator, adjuvanted trivalent seasonal influenza vaccine (aTIV). Antibody responses to aH5N1 were increased in all four subgroups and, within each age stratum, largely consistent between healthy subjects and those with medical conditions. Injection-site pain was reported by 66-73% of younger and 36-42% of older-aH5N1 recipients, and fatigue and myalgia were reported by 22-41% of subjects across age and health subgroups. No serious adverse events or deaths were considered related to the study vaccine. In conclusion, aH5N1 increased antibody responses regardless of age or health status and demonstrated a clinically acceptable safety and tolerability profile.
Keywords: adjuvanted H5N1 vaccine; high-risk medical conditions; older adults; pandemic influenza; pandemic influenza vaccine.
. 2024 Apr 30;12(5):481.
doi: 10.3390/vaccines12050481. Safety, Tolerability, and Immunogenicity of aH5N1 Vaccine in Adults with and without Underlying Medical Conditions
Tomas Jelinek[SUP] 1 [/SUP], Tino F Schwarz[SUP] 2 [/SUP], Emil Reisinger[SUP] 3 [/SUP], Peter Malfertheiner[SUP] 4 [/SUP], Eve Versage[SUP] 5 [/SUP], Esther Van Twuijver[SUP] 6 [/SUP], Matthew Hohenboken[SUP] 5 [/SUP]
Affiliations
- PMID: 38793732
- PMCID: PMC11125740
- DOI: 10.3390/vaccines12050481
Influenza pandemics pose a serious risk to the global population, with the potential for high morbidity and mortality. An adjuvanted H5N1 vaccine (aH5N1) has been approved for prophylaxis against the avian influenza virus H5N1, which is a likely cause of future pandemics. In this phase-III, stratified, randomized, controlled, observer-blind, multicenter study, we evaluated the safety and immunogenicity of aH5N1 in four separate groups of adults: adults 18-60 years of age who were healthy or had high-risk medical conditions and older adults ≥61 years of age who were healthy or had high-risk medical conditions. Subjects were randomly assigned to aH5N1 or the comparator, adjuvanted trivalent seasonal influenza vaccine (aTIV). Antibody responses to aH5N1 were increased in all four subgroups and, within each age stratum, largely consistent between healthy subjects and those with medical conditions. Injection-site pain was reported by 66-73% of younger and 36-42% of older-aH5N1 recipients, and fatigue and myalgia were reported by 22-41% of subjects across age and health subgroups. No serious adverse events or deaths were considered related to the study vaccine. In conclusion, aH5N1 increased antibody responses regardless of age or health status and demonstrated a clinically acceptable safety and tolerability profile.
Keywords: adjuvanted H5N1 vaccine; high-risk medical conditions; older adults; pandemic influenza; pandemic influenza vaccine.