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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03760549
Other study ID # ALT103-201EXT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 21, 2019
Est. completion date February 18, 2019

Study information

Verified date March 2019
Source Altimmune, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date February 18, 2019
Est. primary completion date February 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Optimal Health Research Rockville Maryland

Sponsors (1)

Lead Sponsor Collaborator
Altimmune, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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