search
Back to results

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

Primary Purpose

Influenza, Virus Diseases

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Bird Flu

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rochester Vaccine Evaluation Isolation Unit, St. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Participants will receive 0.5 mL of vaccine intranasally via an Accuspray device (0.25 mL in each nostril)

Outcomes

Primary Outcome Measures

Frequency of vaccine-related reactogenicity events
Area under the curve of nasal viral shedding
Development of serum antibody assessed by either HAI or MN assays

Secondary Outcome Measures

Number of participants infected with the recombinant vaccine candidate
T-cell mediated and innate immune responses against recombinant vaccine candidate
Development of serum bank for testing effectiveness of vaccine against future viruses

Full Information

First Posted
February 26, 2009
Last Updated
December 31, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00853255
Brief Title
Group Study of the Safety of and Immune Response to a Single Dose of Bird Flu Vaccine (H7N3) in Healthy Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Virus Diseases
Keywords
Bird Flu

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive 0.5 mL of vaccine intranasally via an Accuspray device (0.25 mL in each nostril)
Intervention Type
Biological
Intervention Name(s)
Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca)
Intervention Description
Vaccine administered by nasal spray
Primary Outcome Measure Information:
Title
Frequency of vaccine-related reactogenicity events
Time Frame
During inpatient stage
Title
Area under the curve of nasal viral shedding
Time Frame
Days 2 through 9
Title
Development of serum antibody assessed by either HAI or MN assays
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Number of participants infected with the recombinant vaccine candidate
Time Frame
Throughout study
Title
T-cell mediated and innate immune responses against recombinant vaccine candidate
Time Frame
Throughout study
Title
Development of serum bank for testing effectiveness of vaccine against future viruses
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Treanor, MD
Organizational Affiliation
Infectious Diseases Division, University of Rochester Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Vaccine Evaluation Isolation Unit, St. Mary's Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
55902
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16447497
Citation
Alexander DJ. Avian influenza viruses and human health. Dev Biol (Basel). 2006;124:77-84.
Results Reference
background
PubMed Identifier
17634234
Citation
Joseph T, McAuliffe J, Lu B, Jin H, Kemble G, Subbarao K. Evaluation of replication and pathogenicity of avian influenza a H7 subtype viruses in a mouse model. J Virol. 2007 Oct;81(19):10558-66. doi: 10.1128/JVI.00970-07. Epub 2007 Jul 18.
Results Reference
background
PubMed Identifier
18585748
Citation
Joseph T, McAuliffe J, Lu B, Vogel L, Swayne D, Jin H, Kemble G, Subbarao K. A live attenuated cold-adapted influenza A H7N3 virus vaccine provides protection against homologous and heterologous H7 viruses in mice and ferrets. Virology. 2008 Aug 15;378(1):123-32. doi: 10.1016/j.virol.2008.05.021. Epub 2008 Jun 27.
Results Reference
background
PubMed Identifier
17200390
Citation
Skowronski DM, Li Y, Tweed SA, Tam TW, Petric M, David ST, Marra F, Bastien N, Lee SW, Krajden M, Brunham RC. Protective measures and human antibody response during an avian influenza H7N3 outbreak in poultry in British Columbia, Canada. CMAJ. 2007 Jan 2;176(1):47-53. doi: 10.1503/cmaj.060204.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs