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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.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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) ]
  • Immunogenicity (humoral) defined by H5 HAI titer [ Time Frame: At all available timepoints ]

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PaxVax, Inc.
ClinicalTrials.gov Identifier: NCT01006798     History of Changes
Other Study ID Numbers: PXVX-H5-103-001
First Submitted: November 2, 2009
First Posted: November 3, 2009
Last Update Posted: July 1, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs