Study of the Safety and Immunogenicity of NasoVAX Extension

NCT ID: NCT03760549

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-21

Study Completion Date

2019-02-18

Brief Summary

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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

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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.

Conditions

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Influenza

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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.

Subjects were administered NasoVAX high dose

Intervention Type DRUG

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

Interventions

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Subjects were administered NasoVAX high dose

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Altimmune, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peta-Gay Jackson-Booth, MD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

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Optimal Health Research

Rockville, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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ALT103-201EXT

Identifier Type: -

Identifier Source: org_study_id

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