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Study of the Safety and Immunogenicity of NasoVAX Extension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03760549
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Influenza Drug: Subjects were administered NasoVAX high dose

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.

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Other
Time Perspective: Other
Official Title: Extension Study for Study ALT-103-201: One-year Follow-up for the 1×10(11th) vp NasoVAX Group
Actual Study Start Date : January 21, 2019
Actual Primary Completion Date : February 18, 2019
Actual Study Completion Date : February 18, 2019

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760549


Locations
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United States, Maryland
Optimal Health Research
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
Altimmune, Inc.
Investigators
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Principal Investigator: Peta-Gay Jackson-Booth, MD Study Principal Investigator
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Responsible Party: Altimmune, Inc.
ClinicalTrials.gov Identifier: NCT03760549    
Other Study ID Numbers: ALT103-201EXT
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No