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Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01006798
First Posted: November 3, 2009
Last Update Posted: July 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PaxVax, Inc.
November 2, 2009
November 3, 2009
July 1, 2013
October 2009
September 2011   (Final data collection date for primary outcome measure)
  • Safety, defined as the frequency and severity of vaccine-related reactogenicity events and reported AEs [ Time Frame: Throughout trial (reactogenicity for 7 days following each vaccination) ]
  • Immunogenicity (humoral) defined by H5 HAI titer [ Time Frame: At all available timepoints ]
Same as current
Complete list of historical versions of study NCT01006798 on ClinicalTrials.gov Archive Site
  • Immunogenicity (humoral), defined by Ad4 antibody response [ Time Frame: At all available timepoints ]
  • Replication/excretion of Ad4-H5-Vtn virus [ Time Frame: Throughout trial ]
  • Transmission to household contacts as measured by AE assessment and antibody response and viral replication/excretion [ Time Frame: Throughout trial ]
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1
Phase 1 Evaluation of the Safety and Immunogenicity of a Replication-Competent Adenovirus Serotype 4-vectored H5N1 Influenza Candidate Vaccine - Ad4-H5-Vtn

The purpose of this study is to compare the safety and immunogenicity over a 9-month period of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in all Household Contacts residing with the vaccinated volunteers.

Vaccinees also may participate in a substudy in which they receive a booster vaccination with the licensed Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).

At least 160 healthy Vaccinees will be randomized into 5 ascending dosage cohorts each consisting of at least 32 volunteers. In each dosage cohort Vaccinees will be randomly assigned to receive 3 doses of either Ad4-H5-Vtn or placebo separated by approximately 56 days. Volunteers will be followed for 168 days post-third vaccination.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
  • Bird Flu
  • Influenza
  • Other: Placebo
    enteric coated capsule containing no vaccine virus
    Other Name: Placebo for Ad4-H5-Vtn
  • Biological: Ad4-H5-Vtn
    a live, replication-competent, recombinant Ad4 virus expressing the HA of H5N1 influenza (A/Vietnam/1194/2004) in an enteric capsule for oral administration
    Other Name: Adenovirus Serotype 4-vectored H5N1 Influenza Vaccine
  • Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1
    Single administration of a heterologous boost given to volunteers 3 to 15 months following their last vaccination with Ad4-H5-Vtn or placebo.
    Other Names:
    • FDA-licensed inactivated monovalent Influenza Virus Vaccine, H5N1
    • licensed H5N1 vaccine
  • Experimental: Cohort 1
    three vaccinations of 10^7vp Ad4-H5-Vtn or placebo
    Interventions:
    • Other: Placebo
    • Biological: Ad4-H5-Vtn
    • Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1
  • Experimental: Cohort 2
    three vaccinations of the 10^8vp Ad4-H5-Vtn or placebo
    Interventions:
    • Other: Placebo
    • Biological: Ad4-H5-Vtn
    • Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1
  • Experimental: Cohort 3
    three vaccinations of 10^9 Ad4-H5-Vtn or placebo
    Interventions:
    • Other: Placebo
    • Biological: Ad4-H5-Vtn
    • Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1
  • Experimental: Cohort 4
    three vaccinations of 10^10 Ad4-H5-Vtn or placebo
    Interventions:
    • Other: Placebo
    • Biological: Ad4-H5-Vtn
    • Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1
  • Experimental: Cohort 5
    three vaccinations of 10^11 Ad4-H5-Vtn or placebo
    Interventions:
    • Other: Placebo
    • Biological: Ad4-H5-Vtn
    • Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1
Gurwith M, Lock M, Taylor EM, Ishioka G, Alexander J, Mayall T, Ervin JE, Greenberg RN, Strout C, Treanor JJ, Webby R, Wright PF. Safety and immunogenicity of an oral, replicating adenovirus serotype 4 vector vaccine for H5N1 influenza: a randomised, double-blind, placebo-controlled, phase 1 study. Lancet Infect Dis. 2013 Mar;13(3):238-50. doi: 10.1016/S1473-3099(12)70345-6. Epub 2013 Jan 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
166
September 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy adults and their healthy adult household contacts.

Exclusion Criteria:

  • Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have an unstable medical condition, or are under the age of 18.
  • Childcare workers who have direct contact with children 5 years old and younger.
  • Resides with Household Contacts who are under the age of 18 or over the age of 65.
  • Received or plans to receive licensed inactivated 2009 H1N1 influenza vaccine from 14 days prior to 14 days after any study vaccination.
  • Received or plans to receive any other licensed vaccines from 30 days prior to the first study vaccination until 30 days after the third study vaccination.
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01006798
PXVX-H5-103-001
Yes
Not Provided
Not Provided
PaxVax, Inc.
PaxVax, Inc.
Not Provided
Study Director: Marc Gurwith, M.D., J.D. PaxVax, Inc.
PaxVax, Inc.
June 2013

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