search
Back to results

Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study B)

Primary Purpose

Influenza, Virus Diseases

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 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, Avian Flu

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Born after 1968
  • Good general health
  • Available for the duration of the study
  • Female participants must agree to use acceptable forms of contraception

Exclusion Criteria:

  • Significant medical illness, physical examination findings, or urine or blood abnormalities
  • Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
  • Previously enrolled in an H9N2 influenza vaccine study or in any other study of a bird flu vaccine
  • Positive for the H9N2 influenza A virus (serum hemagglutination inhibiting [HI] factor antibody titer greater than 1:8)
  • Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months prior to study entry
  • History of severe allergic reaction or anaphylaxis
  • Current asthma or reactive airway disease within 2 years prior to study entry
  • History of Guillain-Barre syndrome
  • HIV-1 serotype positive
  • Hepatitis C virus (HCV) positive
  • Hepatitis B surface antigen positive
  • Known immunodeficiency syndrome
  • Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used topical corticosteroids are not excluded.
  • Live vaccine within 4 weeks prior to study entry
  • Killed vaccine within 2 weeks prior to study entry
  • Absence of spleen
  • Blood products within 6 months prior to study entry
  • Current smoker unwilling to stop smoking for the duration of the study
  • Plans to travel to the Southern Hemisphere or Asia within 14 days prior to study entry
  • Plans to travel on a cruise ship within 14 days prior to study entry
  • Work in the poultry industry
  • Received an investigational agent within 30 days prior to study entry
  • Allergy to eggs or egg products
  • Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
  • Family member with immunodeficiency
  • Other condition that, in the opinion of the investigator, would affect participation in the study
  • Pregnancy or breastfeeding

Sites / Locations

  • Center for Immunization Research Inpatient Unit, Mason F. Lord Building, Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Two vaccinations with H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine at a dose of 10^7 TCID50 delivered by nose drops. The second vaccination will be given 4 to 12 weeks after the first.

Outcomes

Primary Outcome Measures

Safety, as defined by frequency of vaccine-related reactogenicity events and other adverse events (AEs) for each dose
Immunogenicity, as determined by antibody to H9N2
Determining the amount of serum and nasal wash antibody induced by the vaccine

Secondary Outcome Measures

To determine the number of vaccinees infected with the H9N2 G9/AA ca reassortant vaccine candidate
To determine the phenotypic stability of vaccine virus shed
To develop a serum bank so that the capacity of the H9N2 G9/AA ca reassortant vaccine candidate to elicit HI and neutralizing antibodies to future H9N2 influenza viruses can be tested
To evaluate T-cell mediated and innate immune responses against the H9N2 G9/AA ca reassortant vaccine candidate

Full Information

First Posted
September 22, 2006
Last Updated
January 18, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Johns Hopkins Bloomberg School of Public Health
search

1. Study Identification

Unique Protocol Identification Number
NCT00380237
Brief Title
Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study B)
Official Title
Phase 1 Inpatient Study of the Safety and Immunogenicity of H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H9N2 Infection in the Event of a Pandemic (Study B)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Avian influenza (AI), also known as bird flu, has become a major public health concern in many regions of the world. The purpose of this study is to evaluate the safety of and immune response to an AI vaccine in healthy adults.
Detailed Description
AI is caused by a virus that occurs naturally among birds. Because the virus has the ability to mutate into a form that can efficiently spread among the human population, AI has the potential to cause pandemics. The purpose of this study is to evaluate the safety of and immune response to the AI vaccine H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) in healthy adults who have never been exposed to the H9N2 virus. This study will last from approximately 6 weeks, up to a maximum of approximately 20 weeks. Participation includes a 10-day minimum hospital stay in an isolation unit of the Bayview Medical Center of Johns Hopkins University. Participants will be admitted to the isolation unit 2 days prior to vaccination. At vaccination, participants will be given one dose of the H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine in the form of nose drops. Each day for the next 7 days, participants' vital signs will be monitored and nasal washes will be collected to test for the presence of vaccine virus. Participants may be discharged from the hospital after 3 consecutive negative viral cultures, but not before Day 7 after vaccination. Follow-up visits will occur on Days 21, 28, and 42, and will include blood collection and a physical exam. Participants who received the first dose of the (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine will be asked to receive a second dose of the vaccine 4 to 12 weeks after receiving the initial dose. Study procedures will be identical to those related to the first vaccination.

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, Avian 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
Two vaccinations with H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine at a dose of 10^7 TCID50 delivered by nose drops. The second vaccination will be given 4 to 12 weeks after the first.
Intervention Type
Biological
Intervention Name(s)
H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)
Intervention Description
Live attenuated H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine
Primary Outcome Measure Information:
Title
Safety, as defined by frequency of vaccine-related reactogenicity events and other adverse events (AEs) for each dose
Time Frame
Throughout study
Title
Immunogenicity, as determined by antibody to H9N2
Time Frame
At Days 0, 28, and 42
Title
Determining the amount of serum and nasal wash antibody induced by the vaccine
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
To determine the number of vaccinees infected with the H9N2 G9/AA ca reassortant vaccine candidate
Time Frame
Throughout study
Title
To determine the phenotypic stability of vaccine virus shed
Time Frame
Throughout study
Title
To develop a serum bank so that the capacity of the H9N2 G9/AA ca reassortant vaccine candidate to elicit HI and neutralizing antibodies to future H9N2 influenza viruses can be tested
Time Frame
Throughout study
Title
To evaluate T-cell mediated and innate immune responses against the H9N2 G9/AA ca reassortant vaccine candidate
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Born after 1968 Good general health Available for the duration of the study Female participants must agree to use acceptable forms of contraception Exclusion Criteria: Significant medical illness, physical examination findings, or urine or blood abnormalities Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study Previously enrolled in an H9N2 influenza vaccine study or in any other study of a bird flu vaccine Positive for the H9N2 influenza A virus (serum hemagglutination inhibiting [HI] factor antibody titer greater than 1:8) Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months prior to study entry History of severe allergic reaction or anaphylaxis Current asthma or reactive airway disease within 2 years prior to study entry History of Guillain-Barre syndrome HIV-1 serotype positive Hepatitis C virus (HCV) positive Hepatitis B surface antigen positive Known immunodeficiency syndrome Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used topical corticosteroids are not excluded. Live vaccine within 4 weeks prior to study entry Killed vaccine within 2 weeks prior to study entry Absence of spleen Blood products within 6 months prior to study entry Current smoker unwilling to stop smoking for the duration of the study Plans to travel to the Southern Hemisphere or Asia within 14 days prior to study entry Plans to travel on a cruise ship within 14 days prior to study entry Work in the poultry industry Received an investigational agent within 30 days prior to study entry Allergy to eggs or egg products Purified protein derivative (PPD) positive (positive tuberculosis [TB] test) Family member with immunodeficiency Other condition that, in the opinion of the investigator, would affect participation in the study Pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth A. Karron, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Immunization Research Inpatient Unit, Mason F. Lord Building, Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15280470
Citation
Choi YK, Ozaki H, Webby RJ, Webster RG, Peiris JS, Poon L, Butt C, Leung YH, Guan Y. Continuing evolution of H9N2 influenza viruses in Southeastern China. J Virol. 2004 Aug;78(16):8609-14. doi: 10.1128/JVI.78.16.8609-8614.2004.
Results Reference
background
PubMed Identifier
10774473
Citation
Cox NJ, Subbarao K. Global epidemiology of influenza: past and present. Annu Rev Med. 2000;51:407-21. doi: 10.1146/annurev.med.51.1.407.
Results Reference
background
PubMed Identifier
16026813
Citation
Li C, Yu K, Tian G, Yu D, Liu L, Jing B, Ping J, Chen H. Evolution of H9N2 influenza viruses from domestic poultry in Mainland China. Virology. 2005 Sep 15;340(1):70-83. doi: 10.1016/j.virol.2005.06.025.
Results Reference
background
PubMed Identifier
10920197
Citation
Lin YP, Shaw M, Gregory V, Cameron K, Lim W, Klimov A, Subbarao K, Guan Y, Krauss S, Shortridge K, Webster R, Cox N, Hay A. Avian-to-human transmission of H9N2 subtype influenza A viruses: relationship between H9N2 and H5N1 human isolates. Proc Natl Acad Sci U S A. 2000 Aug 15;97(17):9654-8. doi: 10.1073/pnas.160270697.
Results Reference
background

Learn more about this trial

Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study B)

We'll reach out to this number within 24 hrs