A Phase I, Dose-Ranging Safety and Immunogenicity Study of an Adenovirus-vectored Intranasal, Pandemic (Hemagglutinin H5) Influenza Vaccine, ADhVN1203/04.H5, in Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- Pandemic Influenza Vaccine
- Conditions
- Influenza A Subtype H5N1 Infection
- Sponsor
- Altimmune, Inc.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies.
The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.
Detailed Description
Objectives: The primary objective is to evaluate the safety of the AdhVN1203/04.H5 vaccine when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age. The secondary objective is to evaluated the immunogenicity of the AdhVN1203/04.H5 vaccine at three different doses (10e8, 10e9 and 10e10 viral particles) when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy males and females in good general health, 19-49 years of age
- •Subjects must provide written consent
- •Willing to participate through study completion
- •Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogenicity analysis
- •Female of child-bearing age must have a negative urine pregnancy test and be stable on a reliable means of contraception.
- •Meet screening criteria for hematology, chemistry and urinalysis
Exclusion Criteria
- •Pregnant (or possibly pregnant) and lactating women
- •Any flu/cold symptoms and/or fever greater than 101 degrees in 3 days prior to study enrollment
- •Any intranasal steroid medication administered in the 10 days prior to study enrollment
- •History of chronic rhinitis or presence of pre-existing nasal septal defects, nasal polyps or other gross abnormalities
- •Any previous nasal cautery or significant surgery for nasal septal defects
- •Any regular past or current use of intranasal illicit drugs or history of intravenous illicit drug use
- •Asthma that is greater than mild in severity
- •Diagnosed active Hepatitis B or C
- •HIV positive at screening
- •Known or suspected malignancy, leukemia, or lymphoma
Arms & Interventions
Group 1
There will be 12 subjects in Group 1 that will receive 10e8 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).
Intervention: Pandemic Influenza Vaccine
Group 2
There will be 12 subjects in Group 2 that will receive 10e9 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).
Intervention: Pandemic Influenza Vaccine
Group 3
There will be 12 subjects in Group 3 that will receive 10e10 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).
Intervention: Pandemic Influenza Vaccine
Experimental: Group 4
There will be 12 subjects in Group 4 that will receive a placebo consisting of buffer administered via intranasal spray on day 0 and day 28 (+/- 4d).
Intervention: Placebo
Outcomes
Primary Outcomes
To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.
Time Frame: 56 day observations with 2 year follow-up
Secondary Outcomes
- Determination of immunogenicity and correlates of protection based on HI titers in vaccinates(28 days and 56 days post vaccination)