Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
- Conditions
- Influenza A Subtype H5N1 Infection
- Interventions
- Biological: Pandemic Influenza VaccineBiological: Placebo
- Registration Number
- NCT00755703
- Lead Sponsor
- Altimmune, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
- Immunosuppressed, altered or compromised immune status as a consequence of disease or treatment with systemic corticosteroids
- Receipt of an influenza vaccine within the past 6 months
- Receipt of any vaccine in the past 30 days
- Receipt of any investigational drug in the past 30 days
- Known Diabetes mellitus
- History of anaphylaxis or angioedema
- Hypertension that is not well controlled
- Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator would serve to interfere or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participants's ability to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Group 1 Pandemic Influenza Vaccine 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). Group 2 Pandemic Influenza Vaccine 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). Group 3 Pandemic Influenza Vaccine 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). Experimental: Group 4 Placebo 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).
- Primary Outcome Measures
Name Time Method To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults. 56 day observations with 2 year follow-up
- Secondary Outcome Measures
Name Time Method Determination of immunogenicity and correlates of protection based on HI titers in vaccinates 28 days and 56 days post vaccination
Trial Locations
- Locations (1)
Alabama Vaccine Research Center (UAB)
🇺🇸Birmingham, Alabama, United States