Study of the Safety and Immunogenicity of NasoVAX Extension

Completed

• Conditions: Influenza
• Interventions: Drug: Subjects were administered NasoVAX high dose

• Registration Number: NCT03760549
• Lead Sponsor: Altimmune, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Study Start: 2019-01-21
• Primary Completion: 2019-02-18
• Study Completion: 2019-02-18
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extension of NasoVAX high dose	Subjects were administered NasoVAX high dose	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.

Primary Outcome Measures

Name	Time	Method
Immune response to NasoVAX when administered by intranasal spray at a single dose of 1×10(11th) vp after approximately 1year	Day 366	Antibody level measured by hemagglutination inhibition titer

Secondary Outcome Measures

Name	Time	Method
Persistence of antivector immune response following NasoVAX administered by intranasal spray at a single 1×10(11th) vp dose after approximately 1year	Day 366	Antibody level measured by Adenovirus serotype 5 neutralization

Trial Locations

Locations (1)

Optimal Health Research; 🇺🇸 Rockville, Maryland, United States