Study of the Safety and Immunogenicity of NasoVAX Extension

NCT03760549 | Completed FDA Drug

• 1 other identifier: ALT103-201EXT
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Persistence of antivector immune response following NasoVAX administered by intranasal spray at a single 1×10(11th) vp dose after approximately 1year

  Day 366

Study Arms (1)

Extension of NasoVAX high dose

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

Interventions

Subjects were administered NasoVAX high dose DRUG

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

Extension of NasoVAX high dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All subjects who were previously randomized to the 1×10(11th) vp NasoVAX group in Study ALT-103-201

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Altimmune, Inc.: lead

Study Sites (1)

Optimal Health Research

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Peta-Gay Jackson-Booth, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 30, 2018
• Study Start: January 21, 2019
• Primary Completion: February 18, 2019
• Study Completion: February 18, 2019
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (1)