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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PaxVax, Inc.
ClinicalTrials.gov Identifier:
NCT01006798
First received: November 2, 2009
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Bird Flu
Influenza
 Other: Placebo
Biological: Ad4-H5-Vtn
Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase 1 Evaluation of the Safety and Immunogenicity of a Replication-Competent Adenovirus Serotype 4-vectored H5N1 Influenza Candidate Vaccine - Ad4-H5-Vtn

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu
U.S. FDA Resources

Further study details as provided by PaxVax, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Immunogenicity (humoral) defined by H5 HAI titer [ Time Frame: At all available timepoints ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity (humoral), defined by Ad4 antibody response [ Time Frame: At all available timepoints ] [ Designated as safety issue: No ]
  • Replication/excretion of Ad4-H5-Vtn virus [ Time Frame: Throughout trial ] [ Designated as safety issue: No ]
  • Transmission to household contacts as measured by AE assessment and antibody response and viral replication/excretion [ Time Frame: Throughout trial ] [ Designated as safety issue: No ]

Enrollment: 166
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
three vaccinations of 10^7vp Ad4-H5-Vtn or placebo
 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 2
three vaccinations of the 10^8vp Ad4-H5-Vtn or placebo
 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 3
three vaccinations of 10^9 Ad4-H5-Vtn or placebo
 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 4
three vaccinations of 10^10 Ad4-H5-Vtn or placebo
 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 5
three vaccinations of 10^11 Ad4-H5-Vtn or placebo
 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006798

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, South Carolina
Coastal Carolina Research Center, Inc.
Mt Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
PaxVax, Inc.
Investigators
Study Director: Marc Gurwith, M.D., J.D. PaxVax, Inc.
  More Information

No publications provided

Responsible Party: PaxVax, Inc.
ClinicalTrials.gov Identifier: NCT01006798     History of Changes
Other Study ID Numbers: PXVX-H5-103-001
Study First Received: November 2, 2009
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by PaxVax, Inc.:
Virus Diseases
Respiratory Tract Diseases
Vaccine

Additional relevant MeSH terms:
Influenza in Birds
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013