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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014