Safety and Immunogenicity Study of Adenovirus-Vectored, Intranasal Pandemic Influenza Vaccine. - Full Text View

Sponsored by:	Vaxin Inc.
Information provided by:	Vaxin Inc.
ClinicalTrials.gov Identifier:	NCT00755703

Purpose

The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose,needleless vaccination (into the nasal passages) using adenovirus-recombinant vaccines 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.

Condition	Intervention	Phase
Pandemic Influenza	Biological: Pandemic Influenza Vaccine	Phase I

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Factorial Assignment, Safety/Efficacy Study
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

Further study details as provided by Vaxin Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determination of immunogenicity and correlates of protection based on HI titers in vaccinates [ Time Frame: 28 days and 56 days post vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	September 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental There will be 16 subjects, twelve vaccinates and non-vaccinates, in Group 1. The vaccinates will receive 10e8 viral particles administered via intranasal spray on day 0 and day 28 (+/- 4d). The controls will receive a placebo consisting of viral buffer administered in a similar manner.	Biological: Pandemic Influenza Vaccine Undetermined
Group 2: Experimental There will be sixteen subjects, twelve vaccinates and four controls. The vaccinates will receive 10e9 viral particles administered via nasal spray on day 0 and day 28 (+/- 4 d) while the controls will receive a similarly administered placebo consist of viral buffer.	Biological: Pandemic Influenza Vaccine Undetermined
Group 3: Experimental There will be 16 subjects, twelve vaccinates and four controls, in Group 3. The vaccinates will receive 10e10 viral particles administered via intranasal spray on day 0 and day 28 (+/-4d). The controls will receive viral buffer administered in a similar fashion.	Biological: Pandemic Influenza Vaccine Undetermined

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.

Eligibility

Ages Eligible for Study:	19 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755703

Locations

United States, Alabama
Alabama Vaccine Research Center (UAB)
Birmingham, Alabama, United States, 35294-2050

Sponsors and Collaborators

Vaxin Inc.

Investigators

Principal Investigator:

Scott D. Parker, M.D.

Alabama Vaccine Research Clinic, University of Alabama at Birmingham

More Information

Responsible Party:	Vaxin Inc. ( Kent R. Van Kampen COO )
Study ID Numbers:	H-0701-2, #1-UCI-AI-06205-01
Study First Received:	September 17, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00755703
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vaxin Inc.:

Influenza
Vaccine
Pandemic
Avian influenza
Adenovirus strain 5

Vectored vaccine
Intranasal
Tissue-culture derived
Non-replicating

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Adenoviridae Infections

Influenza, Human
Influenza in Birds
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 13, 2009