NCT03760549

Study of the Safety and Immunogenicity of NasoVAX Extension

Extension Study for Study ALT-103-201: One-year Follow-up for the 1×10(11th) vp NasoVAX Group

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Altimmune, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Influenza

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-01-21
• Primary completion: 2019-02-18
• Completion: 2019-02-18
• First posted: 2018-11-30
• Last updated: 2025-06-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study