Vaccine · 2026
A Phase IIa randomized clinical trial of a respiratory syncytial virus and human metapneumovirus combination protein-based virus-like particle vaccine in adults 60-85 years of age.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Davis Matthew, Shapiro Craig, Ciarlet Max, Adams Elizabeth M, Hourguettes Nicholas, Engram April E, Wen Judy, Bansal Himanshu, Shoemaker Kathryn, Rida Wasima, Aksyuk Anastasia A, Price Jennifer, Oyedele Tope, Chang Lee-Jah, Kanesa-Thasan Niranjan
Аннотация
BACKGROUND: Respiratory syncytial virus (RSV)- and human metapneumovirus (hMPV)-associated lower respiratory tract disease (LRTD) contributes substantially to morbidity and mortality in older adults. IVX-A12 is an investigational combination vaccine comprised of two virus-like particles computationally designed to elicit immune responses against RSV and hMPV. In a Phase I randomized trial, IVX-A12 was well tolerated and elicited RSV- and hMPV-specific neutralizing antibody (nAb) responses in adults 60-75 years of age.
METHODS: In this Phase IIa trial, healthy adults 60-85 years of age, including participants with stable, chronic conditions, were randomized 2:2:1 to receive one intramuscular dose of IVX-A12 (150 μg RSV/150 μg hMPV) with/without MF59® (oil-in-water adjuvant), or placebo (diluent), stratified by age group (60-69/70-85 years). Safety and immunogenicity were assessed through 365 days post-vaccination.
RESULTS: Overall, 264 participants received IVX-A12 (n = 211) or placebo (n = 53). Solicited adverse reactions were mild-to-moderate in severity and were reported by 57.3% (n = 59/103), 75.0% (n = 81/108), and 37.7% (n = 20/53) of recipients of unadjuvanted IVX-A12, IVX-A12 + MF59®, and placebo, respectively. IVX-A12 induced increases in nAbs against RSV and hMPV. From baseline to Day 28, in IVX-A12 (±MF59®) recipients, nAbs against RSV A and B increased 5-6- and 3-4-fold, respectively, and nAbs against hMPV A and B both increased 2-3-fold. In IVX-A12 recipients, all except hMPV A nAbs remained above baseline levels at Day 365 and were higher than in placebo recipients. Addition of MF59® to IVX-A12 did not boost antibody responses nor increase their duration. Safety and immunogenicity were similar between the stratified age groups.
CONCLUSIONS: IVX-A12 was well tolerated and induced RSV- and hMPV-specific antibody responses in adults 60-85 years of age. This trial demonstrated the feasibility of an RSV/hMPV combination vaccine.
METHODS: In this Phase IIa trial, healthy adults 60-85 years of age, including participants with stable, chronic conditions, were randomized 2:2:1 to receive one intramuscular dose of IVX-A12 (150 μg RSV/150 μg hMPV) with/without MF59® (oil-in-water adjuvant), or placebo (diluent), stratified by age group (60-69/70-85 years). Safety and immunogenicity were assessed through 365 days post-vaccination.
RESULTS: Overall, 264 participants received IVX-A12 (n = 211) or placebo (n = 53). Solicited adverse reactions were mild-to-moderate in severity and were reported by 57.3% (n = 59/103), 75.0% (n = 81/108), and 37.7% (n = 20/53) of recipients of unadjuvanted IVX-A12, IVX-A12 + MF59®, and placebo, respectively. IVX-A12 induced increases in nAbs against RSV and hMPV. From baseline to Day 28, in IVX-A12 (±MF59®) recipients, nAbs against RSV A and B increased 5-6- and 3-4-fold, respectively, and nAbs against hMPV A and B both increased 2-3-fold. In IVX-A12 recipients, all except hMPV A nAbs remained above baseline levels at Day 365 and were higher than in placebo recipients. Addition of MF59® to IVX-A12 did not boost antibody responses nor increase their duration. Safety and immunogenicity were similar between the stratified age groups.
CONCLUSIONS: IVX-A12 was well tolerated and induced RSV- and hMPV-specific antibody responses in adults 60-85 years of age. This trial demonstrated the feasibility of an RSV/hMPV combination vaccine.
Предметные рубрики MeSH
HumansMiddle AgedAgedFemaleMetapneumovirusAntibodies, ViralMaleAntibodies, NeutralizingAged, 80 and overRespiratory Syncytial Virus VaccinesVaccines, Virus-Like ParticleRespiratory Syncytial Virus InfectionsParamyxoviridae InfectionsRespiratory Syncytial Virus, HumanAdjuvants, ImmunologicPolysorbatesSqualeneViral Vaccines