Group Study of the Safety of and Immune Response to a Single Dose of Bird Flu Vaccine (H7N3) in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00853255
First received: February 26, 2009
Last updated: December 31, 2012
Last verified: December 2012
  Purpose

Over the past decade, avian influenza (AI) has become a major health concern. The development of safe and effective vaccines against avian strains that infect people is important. The purpose of this study is to determine the safety of and immune response of an investigational AI vaccine in healthy adults against the H7N3 strain of avian influenza.


Condition Intervention Phase
Influenza
Virus Diseases
Biological: Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 1 Inpatient Study of the Safety and Immunogenicity of One Dose of Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/Chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H7N3 Infection in the Event of a Pandemic

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Frequency of vaccine-related reactogenicity events [ Time Frame: During inpatient stage ] [ Designated as safety issue: Yes ]
  • Area under the curve of nasal viral shedding [ Time Frame: Days 2 through 9 ] [ Designated as safety issue: No ]
  • Development of serum antibody assessed by either HAI or MN assays [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants infected with the recombinant vaccine candidate [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • T-cell mediated and innate immune responses against recombinant vaccine candidate [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Development of serum bank for testing effectiveness of vaccine against future viruses [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive 0.5 mL of vaccine intranasally via an Accuspray device (0.25 mL in each nostril)
Biological: Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca)
Vaccine administered by nasal spray

Detailed Description:

The current pandemic risk associated with avian influenza H7N3 infection is significant, as an increasing number of humans are infected. H7 influenza transmission usually occurs in humans when they are exposed through direct contact to infected poultry or surfaces and objects contaminated by infected poultry feces. A pandemic occurs when a new influenza subtype emerges that infects humans, causes serious illness, and spreads easily between humans. The development of a safe and effective vaccine is necessary. The purpose of this study is to evaluate the safety and immunogenicity of a one-dose administration of the live, attenuated AI virus vaccine, H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca).

This study will last approximately 180 days. Participation in this study includes one 12-day hospital stay in an isolation unit at the University of Rochester Vaccine Evaluation Isolation Unit at St. Mary's Hospital in Rochester, NY. All participants will receive one dose of vaccine in nasal spray form at study entry. Participants will be admitted to the isolation unit 2 days prior to vaccination. A targeted physical exam, vital signs measurement, and nasal wash will occur daily following each vaccination until discharge. Participants will be discharged after two consecutive nasal washes on or after Day 7 are negative. Blood and urine collection will occur at selected timepoints throughout the study. Follow-up outpatient visits will occur approximately at Days 28, 56, and 180. A nasal wash and adverse events evaluation will occur at each follow-up visit.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health
  • Available for the duration of the trial
  • For females, willing to use acceptable forms of contraception for the duration of the study. More information on this criterion can be found in the protocol.

Exclusion Criteria:

  • Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
  • Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may affect study participation
  • Previously enrolled in an H7N3 influenza vaccine trial or in any study of an avian influenza vaccine
  • Seropositive to the H7N3 influenza A virus (serum hemagglutination inhibition [HI] titer greater than 1:8)
  • Illegal drug use or dependency determined by urine test
  • Medical, work, or family problems as a result of alcohol or illicit drug use within 12 months prior to study entry
  • History of severe allergic reaction
  • Allergy to oseltamivir
  • Asthma or reactive airways disease within 2 years prior to study entry
  • History of Guillain-Barre syndrome
  • HIV-infected
  • Hepatitis C virus infected
  • Positive for hepatitis B surface antigen (HBsAg)
  • Known immunodeficiency syndrome
  • Use of corticosteroids or immunosuppressive drugs within 30 days prior to vaccination. Participants who have used topical corticosteroids are not excluded.
  • Receipt of live vaccines within 4 weeks prior to study vaccination
  • Receipt of killed vaccines within 2 weeks prior to study vaccination
  • Absence of spleen
  • Receipt of blood products within 6 months prior to study vaccination
  • Current smoker unwilling to stop smoking for the duration of the study
  • Have traveled to the Southern Hemisphere within 14 days prior to study vaccination
  • Have traveled on a cruise ship within 14 days prior to study vaccination
  • Work in the poultry industry within 14 days prior to or after study vaccination
  • Other investigational vaccine or drug within 30 days prior to study vaccination
  • Allergy to eggs or egg products
  • Other condition that, in the opinion of the investigator, may interfere with the study
  • Pregnant or breastfeeding
  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: NCT00853255

Locations
United States, New York
University of Rochester Vaccine Evaluation Isolation Unit, St. Mary's Hospital
Rochester, New York, United States, 55902
Sponsors and Collaborators
Investigators
Principal Investigator: John Treanor, MD Infectious Diseases Division, University of Rochester Medical Center
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00853255     History of Changes
Other Study ID Numbers: CIR 260, CIR 260
Study First Received: February 26, 2009
Last Updated: December 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Bird Flu

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

ClinicalTrials.gov processed this record on August 19, 2014