An observational study in Influenza, sponsored by Altimmune, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Altimmune, Inc. · Observational
This study is an extension to Study ALT-103-201, a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age.
This study is an extension to Study ALT-103-201 to evaluate immunogenicity of NasoVAX administered by intranasal spray at a single dose of 1×1011 vp at Day 366 (± 60 days). Up to 15 subjects who received NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 will be screened, and a serum sample will be collected from each eligible subject for evaluation of influenza HAI assay against influenza A/California/07/2009(H1N1), a strain homologous to the one used for NasoVAX (monovalent AdcoCA09.HA). Ad5 antibody neutralization assay may also be performed.
Altimmune, Inc. is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 4 (31%) have results posted.
Counted across the registry records on this site, refreshed daily.
All subjects who were previously randomized to the 1×10(11th) vp NasoVAX group in Study ALT-103-201
Exclusion:
A serum sample will be collected from each eligible subject who received NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 for evaluation of influenza hemagglutination assay against influenza A/California/07/2009(H1N1), a strain homologous to the one used for NasoVAX (monovalent AdcoCA09.HA). Ad5 antibody neutralization assay may also be performed.
Drug: Subjects were administered NasoVAX high dose
NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo
Immune response to NasoVAX when administered by intranasal spray at a single dose of 1×10(11th) vp after approximately 1year
Antibody level measured by hemagglutination inhibition titer
Time frame: Day 366
Persistence of antivector immune response following NasoVAX administered by intranasal spray at a single 1×10(11th) vp dose after approximately 1year
Antibody level measured by Adenovirus serotype 5 neutralization
Time frame: Day 366
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Altimmune, Inc.