Study of the Safety and Immunogenicity of NasoVAX Extension



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 50
Updated:3/7/2019
Start Date:January 21, 2019
End Date:February 18, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

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
We found this trial at
1
site
Optimal Health Research
15201 Shady Grove Road
Rockville, Maryland 20850
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mi
from
Rockville, MD
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