Clinical trial NCT00755703: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza A Subtype H5N1 Infection
Keywords: Influenza
Vaccine
Pandemic
Avian influenza
Adenovirus strain 5
Vectored vaccine
Intranasal
Tissue-culture derived
Non-replicating
Lead sponsor: Altimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.
timeFrame: 56 day observations with 2 year follow-up
Secondary outcomes:
measure: Determination of immunogenicity and correlates of protection based on HI titers in vaccinates
timeFrame: 28 days and 56 days post vaccination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Vaccine Research Center (UAB)
state: Alabama
Study officials:
affiliation: Alabama Vaccine Research Clinic, University of Alabama at Birmingham
name: Scott D. Parker, M.D.
role: PRINCIPAL_INVESTIGATOR
References: