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Virus Therapy
Study of the Safety and Immunogenicity of NasoVAX Extension
N/A
Waitlist Available
Led By Peta-Gay Jackson-Booth, MD
Research Sponsored by Altimmune, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 366
Awards & highlights
No Placebo-Only Group
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 366
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 366
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Immune response to NasoVAX when administered by intranasal spray at a single dose of 1×10(11th) vp after approximately 1year
Secondary study objectives
Persistence of antivector immune response following NasoVAX administered by intranasal spray at a single 1×10(11th) vp dose after approximately 1year
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Extension of NasoVAX high doseExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NasoVAX
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Altimmune, Inc.Lead Sponsor
16 Previous Clinical Trials
1,537 Total Patients Enrolled
Peta-Gay Jackson-Booth, MDPrincipal InvestigatorStudy Principal Investigator