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Single Group Study of the Safety of and Immune Response to a 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
  • Willing to use acceptable forms of contraception for the duration of the study

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.
  • Live vaccines within 4 weeks prior to study vaccination
  • Killed vaccines within 2 weeks prior to study vaccination
  • Absence of spleen
  • 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, Asia, or the United Kingdom 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
  • Other investigational vaccine or drug within 30 days prior to study vaccination
  • Allergy to eggs or egg products
  • Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
  • Have family member with immunodeficiency
  • Other condition that, in the opinion of the investigator, may interfere with the study
  • Pregnancy or breastfeeding

Sites / Locations

  • Center for Immunization Research Inpatient Unit, Mason F. Lord Building, 4940 Eastern Avenue

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

0.50 ml (0.25 ml in each nostril) of Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca) administered by nasal spray at two timepoints (at study entry and between Weeks 4 and 8)

Outcomes

Primary Outcome Measures

Safety, defined as the frequency of vaccine-related reactogenicity events that occur during the acute monitoring (inpatient) phase of the study
Immunogenicity, determined by anti-H7N3 antibody titer
Quantifying the amount of vaccine virus shed by each recipient; and 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 vaccine virus
To determine the phenotypic stability of the vaccine virus
To determine whether immunogenicity is enhanced by a second dose of vaccine
To evaluate T-cell mediated and innate immune responses against the vaccine virus
To develop a serum bank to evaluate future H7 influenza vaccines

Full Information

First Posted
August 13, 2007
Last Updated
May 15, 2015
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Johns Hopkins Bloomberg School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT00516035
Brief Title
Single Group Study of the Safety of and Immune Response to a Bird Flu Vaccine (H7N3) in Healthy Adults
Official Title
Phase 1 Inpatient Study of the Safety and Immunogenicity 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 the Prevention of Avian Influenza H7N3 Infection in the Event of a Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 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
Over the past decade, avian influenza (AI) has become a major health concern. The development of safe and effective vaccines against avian strains infecting people is important. The purpose of this study is to determine the safety of and immune response to a new 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, should a pandemic occur. The purpose of this study is to evaluate the safety and immunogenicity of a 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 90 days. Participation in this study includes two 12-day hospital stays in an isolation unit at the Johns Hopkins Bayview Medical Center. All participants will receive two doses of vaccine in nasal spray form, at study entry and sometime between 4 and 8 weeks after initial vaccination. Participants will be admitted to the isolation unit 2 days prior to each vaccination. A targeted physical exam, vital signs measurement, and a nasal wash will occur daily following each vaccination until discharge. Participants will be discharged after three consecutive nasal washes on or after Day 6 are negative. Blood and urine collection will occur at selected timepoints throughout the study. A follow-up outpatient visit will occur approximately 4 weeks following each 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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
0.50 ml (0.25 ml in each nostril) of Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca) administered by nasal spray at two timepoints (at study entry and between Weeks 4 and 8)
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 given by nasal spray
Primary Outcome Measure Information:
Title
Safety, defined as the frequency of vaccine-related reactogenicity events that occur during the acute monitoring (inpatient) phase of the study
Time Frame
Daily for 9 days after vaccination
Title
Immunogenicity, determined by anti-H7N3 antibody titer
Time Frame
Before the first vaccination, 28 days after the first vaccination but before the second vaccination, and 28 days after the second vaccination
Title
Quantifying the amount of vaccine virus shed by each recipient; and determining the amount of serum and nasal wash antibody induced by the vaccine
Time Frame
Daily for 9 days after vaccination
Secondary Outcome Measure Information:
Title
To determine the number of vaccinees infected with the vaccine virus
Time Frame
Daily for 8 days after each vaccination
Title
To determine the phenotypic stability of the vaccine virus
Time Frame
Throughout study
Title
To determine whether immunogenicity is enhanced by a second dose of vaccine
Time Frame
At study completion
Title
To evaluate T-cell mediated and innate immune responses against the vaccine virus
Time Frame
Throughout study
Title
To develop a serum bank to evaluate future H7 influenza vaccines
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 Willing to use acceptable forms of contraception for the duration of the study 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. Live vaccines within 4 weeks prior to study vaccination Killed vaccines within 2 weeks prior to study vaccination Absence of spleen 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, Asia, or the United Kingdom 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 Other investigational vaccine or drug within 30 days prior to study vaccination Allergy to eggs or egg products Purified protein derivative (PPD) positive (positive tuberculosis [TB] test) Have family member with immunodeficiency Other condition that, in the opinion of the investigator, may interfere with the study Pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kawsar Talaat, 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, 4940 Eastern Avenue
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
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
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
PubMed Identifier
19464558
Citation
Talaat KR, Karron RA, Callahan KA, Luke CJ, DiLorenzo SC, Chen GL, Lamirande EW, Jin H, Coelingh KL, Murphy BR, Kemble G, Subbarao K. A live attenuated H7N3 influenza virus vaccine is well tolerated and immunogenic in a Phase I trial in healthy adults. Vaccine. 2009 Jun 8;27(28):3744-53. doi: 10.1016/j.vaccine.2009.03.082. Epub 2009 Apr 17.
Results Reference
derived
Links:
URL
http://www.jhsph.edu/cir
Description
Click here for the Johns Hopkins Bloomberg School of Public Health - Center for Immunization Research (CIR) Web site

Learn more about this trial

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

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