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Safety of and Immune Response to Recombinant Live-Attenuated Influenza H6N1 Virus Vaccine Vaccine

Primary Purpose

Influenza, Virus Diseases

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
H6N1 Teal HK 97/AA ca recombinant vaccine
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 Vaccine, Influenza

Eligibility Criteria

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

Inclusion Criteria:

  • Adult males and non-pregnant females 18-49 years old
  • General good health
  • Available for the duration of the trial
  • If female, agree to use effective birth control methods for the duration of the study. More information on this criterion can be found in the protocol.

Exclusion Criteria:

  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease. More information on this criterion can be found in the protocol.
  • Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, intereferes with the study
  • Previous receipt of FluMist or any intranasal live attenuated influenza vaccine
  • Previous enrollment in an H6N1 influenza vaccine trial or in any study of an avian influenza vaccine
  • Seropositive to the H6N1 influenza A virus (serum HAI titer >1:8)
  • Positive urine drug toxicology test indicating narcotic use and/or dependency as defined by the Drug Enforcement Agency
  • Medical, occupational, or family problems as a result of alcohol or illicit drug use within the 12 months prior to study entry
  • Any condition that, in the opinion of the investigator, would interfere with the study
  • History of anaphylaxis
  • Allergy to oseltamivir as determined by subject report
  • Current diagnosis of asthma or reactive airway disease within 2 years prior to study entry
  • History of Guillain-Barre Syndrome
  • HIV-1-infected
  • Hepatitis C-infected
  • Positive hepatitis B virus surface antigen
  • Known immunodeficiency syndrome
  • Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to study entry
  • Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study entry
  • History of a surgical splenectomy
  • Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study entry
  • Current smoker unwilling to stop smoking for the duration of the study. More information on this criterion can be found in the protocol.
  • Travel to the Southern Hemisphere within 14 days prior to study entry
  • Travel on a cruise ship within 14 days prior to study entry
  • Direct contact with live poultry within the 14 days prior to the study or after study completion.
  • Receipt of another investigational vaccine or drug within 30 days prior to study entry
  • Allergy to eggs or egg products
  • Pregnant or breastfeeding

Sites / Locations

  • Johns Hopkins Bayview Medical Center, CIR Unit at the Mason F Lord Building

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Participants will receive 2 doses of vaccine 4 to 8 weeks (28-62 days) apart

Outcomes

Primary Outcome Measures

Frequency of vaccine-related reactogenicity events and other adverse events
Amount of vaccine virus shed by each participant
Amount of serum and nasal wash antibody induced by the vaccine

Secondary Outcome Measures

Number of participants infected with the H6N1 Teal HK 97/AA ca recombinant vaccine
Phenotypic stability of vaccine virus shed
Determine whether immunogenicity is enhanced by a second dose of vaccine, and whether the first dose of vaccine restricts replication of the second dose
T-cell mediated and innate immune responses against the H6N1 Teal HK 97/AA ca recombinant vaccine
Development of serum bank so that the capacity of the H6N1 Teal HK 97/AA ca recombinant vaccine to elicit HA1 and neutralizing antibodies to future H6 influenza viruses can be tested

Full Information

First Posted
August 12, 2008
Last Updated
August 5, 2009
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
NCT00734175
Brief Title
Safety of and Immune Response to Recombinant Live-Attenuated Influenza H6N1 Virus Vaccine Vaccine
Official Title
Phase I Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine H6N1 (6-2) AA ca Recombinant (A/Teal/Hong Kong/W312/1997 (H6N1) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H6N1 Infection in the Event of a Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
undefined (undefined)

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
In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H6N1 influenza vaccine candidate.
Detailed Description
H6 influenza viruses are of the low pathogenicity phenotype in poultry, and in the last decade, outbreaks of H6 influenza infection have been reported both in the United States and South Africa. The prevalence of H6 influenza viruses in a wide range of domestic and wild birds, and their propensity for reassortment has raised concerns regarding the pandemic potential of these viruses. This vaccine, therefore, is an important priority in the development of vaccines against potential pandemic influenza strains. This vaccine trial will be conducted in the Center for Immunization Research inpatient unit in the Mason F. Lord Building at the Johns Hopkins Bayview Medical Center (Baltimore, MD). The study will be initiated between April 1st and December 20th, 2008, when wild-type influenza is unlikely to be circulating in the Baltimore area. An individual's participation in the study will last approximately 90 days. All participants will receive two vaccinations approximately 4 - 8 weeks apart. After each vaccination, participants will remain in isolation at the study site for at least nine days or until rRT-PCR assays for influenza are negative for 2 consecutive days. A physical examination and nasal wash will occur each day during the isolation period. Blood collection will occur on the day of admission, the following day, and day 7 after vaccination. Follow-up outpatient visits are scheduled on Days 28 and 56 after the first vaccination and on Day 28 after the second vaccination. Follow-up visits will include serum collection, nasal wash, and interim medical history.

6. Conditions and Keywords

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

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
Participants will receive 2 doses of vaccine 4 to 8 weeks (28-62 days) apart
Intervention Type
Biological
Intervention Name(s)
H6N1 Teal HK 97/AA ca recombinant vaccine
Intervention Description
Approximately 0.2 ml of 10^7 TCID50 doses of vaccine administered intranasally
Primary Outcome Measure Information:
Title
Frequency of vaccine-related reactogenicity events and other adverse events
Time Frame
Throughout study
Title
Amount of vaccine virus shed by each participant
Time Frame
Throughout study
Title
Amount of serum and nasal wash antibody induced by the vaccine
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Number of participants infected with the H6N1 Teal HK 97/AA ca recombinant vaccine
Time Frame
Throughout study
Title
Phenotypic stability of vaccine virus shed
Time Frame
Throughout study
Title
Determine whether immunogenicity is enhanced by a second dose of vaccine, and whether the first dose of vaccine restricts replication of the second dose
Time Frame
Throughout study
Title
T-cell mediated and innate immune responses against the H6N1 Teal HK 97/AA ca recombinant vaccine
Time Frame
Throughout study
Title
Development of serum bank so that the capacity of the H6N1 Teal HK 97/AA ca recombinant vaccine to elicit HA1 and neutralizing antibodies to future H6 influenza viruses can be tested
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: Adult males and non-pregnant females 18-49 years old General good health Available for the duration of the trial If female, agree to use effective birth control methods for the duration of the study. More information on this criterion can be found in the protocol. Exclusion Criteria: Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease. More information on this criterion can be found in the protocol. Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, intereferes with the study Previous receipt of FluMist or any intranasal live attenuated influenza vaccine Previous enrollment in an H6N1 influenza vaccine trial or in any study of an avian influenza vaccine Seropositive to the H6N1 influenza A virus (serum HAI titer >1:8) Positive urine drug toxicology test indicating narcotic use and/or dependency as defined by the Drug Enforcement Agency Medical, occupational, or family problems as a result of alcohol or illicit drug use within the 12 months prior to study entry Any condition that, in the opinion of the investigator, would interfere with the study History of anaphylaxis Allergy to oseltamivir as determined by subject report Current diagnosis of asthma or reactive airway disease within 2 years prior to study entry History of Guillain-Barre Syndrome HIV-1-infected Hepatitis C-infected Positive hepatitis B virus surface antigen Known immunodeficiency syndrome Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to study entry Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study entry History of a surgical splenectomy Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study entry Current smoker unwilling to stop smoking for the duration of the study. More information on this criterion can be found in the protocol. Travel to the Southern Hemisphere within 14 days prior to study entry Travel on a cruise ship within 14 days prior to study entry Direct contact with live poultry within the 14 days prior to the study or after study completion. Receipt of another investigational vaccine or drug within 30 days prior to study entry Allergy to eggs or egg products Pregnant 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
Johns Hopkins Bayview Medical Center, CIR Unit at the Mason F Lord Building
City
Baltimore
State/Province
Maryland
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18582523
Citation
Eichelberger M, Golding H, Hess M, Weir J, Subbarao K, Luke CJ, Friede M, Wood D. FDA/NIH/WHO public workshop on immune correlates of protection against influenza A viruses in support of pandemic vaccine development, Bethesda, Maryland, US, December 10-11, 2007. Vaccine. 2008 Aug 12;26(34):4299-303. doi: 10.1016/j.vaccine.2008.06.012. Epub 2008 Jun 26.
Results Reference
background
PubMed Identifier
18618064
Citation
Hampson AW. Vaccines for pandemic influenza. The history of our current vaccines, their limitations and the requirements to deal with a pandemic threat. Ann Acad Med Singap. 2008 Jun;37(6):510-7.
Results Reference
background
PubMed Identifier
18550873
Citation
Wright PF. Vaccine preparedness--are we ready for the next influenza pandemic? N Engl J Med. 2008 Jun 12;358(24):2540-3. doi: 10.1056/NEJMp0803650. No abstract available.
Results Reference
background
PubMed Identifier
21377509
Citation
Talaat KR, Karron RA, Luke CJ, Thumar B, McMahon BA, Chen GL, Lamirande EW, Jin H, Coelingh KL, Kemble G, Subbarao K. An open label Phase I trial of a live attenuated H6N1 influenza virus vaccine in healthy adults. Vaccine. 2011 Apr 12;29(17):3144-8. doi: 10.1016/j.vaccine.2011.02.043. Epub 2011 Mar 4.
Results Reference
derived

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Safety of and Immune Response to Recombinant Live-Attenuated Influenza H6N1 Virus Vaccine Vaccine

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