Back to resultsSafety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
Primary Purpose
Influenza A Subtype H5N1 Infection
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pandemic Influenza Vaccine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza A Subtype H5N1 Infection focused on measuring Influenza, Vaccine, Pandemic, Avian influenza, Adenovirus strain 5, Vectored vaccine, Intranasal, Tissue-culture derived, Non-replicating
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
- 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
Sites / Locations
- Alabama Vaccine Research Center (UAB)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Group 1
Group 2
Group 3
Experimental: Group 4
Arm Description
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).
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).
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).
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).
Outcomes
Primary Outcome Measures
To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.
Secondary Outcome Measures
Determination of immunogenicity and correlates of protection based on HI titers in vaccinates
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00755703
Brief Title
Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Altimmune, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A Subtype H5N1 Infection
Keywords
Influenza, Vaccine, Pandemic, Avian influenza, Adenovirus strain 5, Vectored vaccine, Intranasal, Tissue-culture derived, Non-replicating
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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).
Arm Title
Group 3
Arm Type
Experimental
Arm Description
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).
Arm Title
Experimental: Group 4
Arm Type
Placebo Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
Pandemic Influenza Vaccine
Intervention Description
Undetermined
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Determination of immunogenicity and correlates of protection based on HI titers in vaccinates
Time Frame
28 days and 56 days post vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott D. Parker, M.D.
Organizational Affiliation
Alabama Vaccine Research Clinic, University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alabama Vaccine Research Center (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-2050
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
We'll reach out to this number within 24 hrs