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

Sponsors

Lead Sponsor: Altimmune, Inc.

Source 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.

Overall Status Completed
Start Date January 21, 2019
Completion Date February 18, 2019
Primary Completion Date February 18, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Immune response to NasoVAX when administered by intranasal spray at a single dose of 1×10(11th) vp after approximately 1year Day 366
Secondary Outcome
Measure Time Frame
Persistence of antivector immune response following NasoVAX administered by intranasal spray at a single 1×10(11th) vp dose after approximately 1year Day 366
Enrollment 8
Condition
Intervention

Intervention Type: Drug

Intervention Name: Subjects were administered NasoVAX high dose

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

Arm Group Label: Extension of NasoVAX high dose

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Peta-Gay Jackson-Booth, MD Principal Investigator Study Principal Investigator
Location
Facility: Optimal Health Research
Location Countries

United States

Verification Date

March 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Arm Group

Label: Extension of NasoVAX high dose

Description: 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.

Study Design Info

Observational Model: Other

Time Perspective: Other

Source: ClinicalTrials.gov