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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03760549

Enrollment

Registered

2018-11-30

Start date

2019-01-21

Completion date

2019-02-18

Last updated

2025-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

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.

Interventions

DRUGSubjects were administered NasoVAX high dose

NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Inclusion: 1. Receipt of NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 2. Adequate venous access for phlebotomy 3. Provision of written informed consent Exclusion: 1\. Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with the subject providing an adequate blood sample or the subject's ability to give informed consent

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026