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Completed

NCT Number: NCT03760549

Study of the Safety and Immunogenicity of NasoVAX Extension

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Optimal Health Research

Rockville, Maryland, 20850, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

Treatment and study plan

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

Primary outcomes

  1. Immune response to NasoVAX when administered by intranasal spray at a single dose of 1×10(11th) vp after approximately 1year

    Time frame: Day 366

    Antibody level measured by hemagglutination inhibition titer

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

    Time frame: Day 366

    Antibody level measured by Adenovirus serotype 5 neutralization

Sponsors and collaborators

Lead sponsor

Altimmune, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 30, 2018
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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