Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vaxin Inc.
ClinicalTrials.gov Identifier:
NCT00755703
First received: September 17, 2008
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Influenza A Subtype H5N1 Infection
Biological: Pandemic Influenza Vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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 ]

Enrollment: 48
Study Start Date: October 2008
Study Completion Date: December 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Biological: Pandemic Influenza Vaccine
Undetermined
Experimental: 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).
Biological: Pandemic Influenza Vaccine
Undetermined
Experimental: 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).
Biological: Pandemic Influenza Vaccine
Undetermined
Placebo Comparator: 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).

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

No publications provided

Responsible Party: Vaxin Inc.
ClinicalTrials.gov Identifier: NCT00755703     History of Changes
Other Study ID Numbers: H-0701-2, #1-UCI-AI-06205-01
Study First Received: September 17, 2008
Last Updated: September 11, 2012
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

Additional relevant MeSH terms:
Adenoviridae Infections
Influenza, Human
DNA Virus Infections
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014