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

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ClinicalTrials.gov Identifier: NCT00755703
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
Altimmune, Inc.

Tracking Information
First Submitted Date  ICMJE September 17, 2008
First Posted Date  ICMJE September 19, 2008
Last Update Posted Date January 1, 2016
Study Start Date  ICMJE October 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00755703 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2008)
Determination of immunogenicity and correlates of protection based on HI titers in vaccinates [ Time Frame: 28 days and 56 days post vaccination ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza A Subtype H5N1 Infection
Intervention  ICMJE
  • Biological: Pandemic Influenza Vaccine
    Undetermined
  • Biological: Placebo
Study Arms  ICMJE
  • 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).
    Intervention: Biological: Pandemic Influenza Vaccine
  • 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).
    Intervention: Biological: Pandemic Influenza Vaccine
  • 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).
    Intervention: Biological: Pandemic Influenza Vaccine
  • 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).
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2008)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00755703
Other Study ID Numbers  ICMJE H-0701-2
#1-UCI-AI-06205-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Altimmune, Inc.
Study Sponsor  ICMJE Altimmune, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott D. Parker, M.D. Alabama Vaccine Research Clinic, University of Alabama at Birmingham
PRS Account Altimmune, Inc.
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP