Influenza Clinical Trial
Official title:
Extension Study for Study ALT-103-201: One-year Follow-up for the 1×10(11th) vp NasoVAX Group
Verified date | March 2019 |
Source | Altimmune, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | February 18, 2019 |
Est. primary completion date | February 18, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Optimal Health Research | Rockville | Maryland |
Lead Sponsor | Collaborator |
---|---|
Altimmune, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Persistence of antivector immune response following NasoVAX administered by intranasal spray at a single 1×10(11th) vp dose after approximately 1year | Antibody level measured by Adenovirus serotype 5 neutralization | Day 366 |
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