Vaccine · 2026
Phase 1 trial of intranasal NDV-HXP-S in previously vaccinated adults.
СтатьяКлиническое исследование I фазыРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Liu Sean T H, González-Domínguez Irene, Martínez-Pérez Amparo, Bozkus Cansu Cimen, Bladh Oscar, Broomes-Pennicott Tarashon, Jen Alina, Egan Elizabeth, Leiva-Ortiz Edna, Abid Ashley, Aguilera Katherina, Åberg Mikael, Bhavsar Disha, Yellin Temima, Abbad Anass, Singh Gagandeep, Carreño Juan Manuel, Adams Joshua, Quigley Christina, Saxena Mansi, Meseck Marcia, Ceglia Ilaria, Thålin Charlotte, Weiskopf Daniela, García-Sastre Adolfo, Palese Peter, Sun Weina, Krammer Florian, Aberg Judith A
Аннотация
BACKGROUND: Newcastle disease virus hexapro spike (NDV-HXP-S) is a recombinant vaccine designed to elicit both systemic and mucosal immunity against SARS-CoV-2. Intramuscular vaccines protect against severe disease but provide limited mucosal protection. We conducted a Phase 1 trial of live NDV-HXP-S administered intranasally (IN), intramuscularly (IM), or simultaneously (IN+IM) in previously vaccinated adults.
METHODS: Thirty-five healthy adults without prior COVID-19 were enrolled at a single site in New York City (Feb 2022-Apr 2024). Participants received low- or high-dose NDV-HXP-S via IN, IM, or IN+IM routes, or placebo. Safety was monitored for 365 days; immune responses in serum and saliva were measured through day 84.
FINDINGS: All 35 participants completed follow-up. NDV-HXP-S was safe and well tolerated, with only grade 1-2 adverse events. Placebo recipients showed waning antibody titers, whereas NDV-HXP-S maintained or boosted serum IgG and neutralizing activity. Salivary sIgA rose modestly. Participants with low baseline CD4+ T-cell activity exhibited increases by day 28. The study was not powered for statistical significance.
INTERPRETATION: Live NDV-HXP-S was safe and well tolerated in this small Phase 1 study. Exploratory immunogenicity analyses showed variable systemic and mucosal responses, supporting further evaluation of updated NDV-HXP-S formulations in larger controlled studies.
FUNDING: Supported by the Icahn School of Medicine Dean's Philanthropic Fund, CastleVax Inc., Mount Sinai CTSA (UL1TR004419), and philanthropic and federal grants.
TRIAL REGISTRATION: ClinicalTrials.govNCT05181709.
METHODS: Thirty-five healthy adults without prior COVID-19 were enrolled at a single site in New York City (Feb 2022-Apr 2024). Participants received low- or high-dose NDV-HXP-S via IN, IM, or IN+IM routes, or placebo. Safety was monitored for 365 days; immune responses in serum and saliva were measured through day 84.
FINDINGS: All 35 participants completed follow-up. NDV-HXP-S was safe and well tolerated, with only grade 1-2 adverse events. Placebo recipients showed waning antibody titers, whereas NDV-HXP-S maintained or boosted serum IgG and neutralizing activity. Salivary sIgA rose modestly. Participants with low baseline CD4+ T-cell activity exhibited increases by day 28. The study was not powered for statistical significance.
INTERPRETATION: Live NDV-HXP-S was safe and well tolerated in this small Phase 1 study. Exploratory immunogenicity analyses showed variable systemic and mucosal responses, supporting further evaluation of updated NDV-HXP-S formulations in larger controlled studies.
FUNDING: Supported by the Icahn School of Medicine Dean's Philanthropic Fund, CastleVax Inc., Mount Sinai CTSA (UL1TR004419), and philanthropic and federal grants.
TRIAL REGISTRATION: ClinicalTrials.govNCT05181709.
Предметные рубрики MeSH
HumansFemaleAdministration, IntranasalAntibodies, ViralMaleAdultAntibodies, NeutralizingNewcastle disease virusMiddle AgedImmunity, MucosalInjections, IntramuscularCOVID-19Immunoglobulin GSARS-CoV-2COVID-19 VaccinesViral VaccinesVaccines, SyntheticVaccinationSalivaYoung AdultVaccines, AttenuatedSpike Glycoprotein, Coronavirus