Study of the Safety and Immunogenicity of NasoVAX Extension

Study Overview
=================
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.

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

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Drug: Subjects were administered NasoVAX high dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Receipt of NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 Adequate venous access for phlebotomy 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Extension of NasoVAX high dose<br>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<br>* NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 366 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 366 |