Phase 1 trial of intranasal NDV-HXP-S in previously vaccinated adults.
VaccineJun 30, 2026 (epub)
Clinical ResearchInfectious Diseases
Sean T H Liu, Irene González-Domínguez, Amparo Martínez-Pérez et al.
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In 30 seconds
This Phase 1 randomized controlled trial evaluated the safety and immunogenicity of intranasal NDV-HXP-S in 35 previously vaccinated adults. The vaccine was well tolerated, with only grade 1-2 adverse events reported. Notably, NDV-HXP-S maintained or boosted serum IgG and neutralizing activity compared to placebo, while salivary sIgA showed modest increases.
Key findings
- NDV-HXP-S was safe and well tolerated, with only grade 1-2 adverse events.
- Placebo recipients exhibited waning antibody titers, while NDV-HXP-S boosted serum IgG and neutralizing activity.
- Salivary sIgA levels rose modestly in participants receiving NDV-HXP-S.
- Participants with low baseline CD4+ T-cell activity showed increases by day 28.
Why it matters
The study highlights the potential of intranasal vaccines to enhance mucosal immunity against SARS-CoV-2, addressing a gap in protection provided by traditional intramuscular vaccines. This could inform future vaccine development strategies.