NCT00110279

Brief Summary

Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and other parts of the world. The purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults. Study hypothesis: Influenza A viruses are widely distributed in nature and infect a wide variety of birds and mammals. The direct transmission of avian influenza viruses from birds to humans has recently become a major health concern in Asia and other parts of the world, raising concern of a possible influenza pandemic in humans. This vaccine will evaluate the safety, infectivity and immunogenicity of Live Influenza A vaccine H9N2 (6-2) AA ca reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a cold-adapted, live attenuated virus vaccine administered intranasally for the protection of humans against pandemic influenza viruses of the H9N2 subtype.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2005

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

January 21, 2008

Status Verified

January 1, 2008

Enrollment Period

3 months

First QC Date

May 5, 2005

Last Update Submit

January 18, 2008

Conditions

InfluenzaVirus Diseases

Keywords

Bird Flu

Outcome Measures

Primary Outcomes (2)

  • Frequency of vaccine-related reactogenicity events and other adverse effects for each dose of the H9N2 G9/AA ca reassortant vaccine

    Throughout study

  • Immunogenicity and infectivity for each dose of the H9N2 G9/AA ca reassortant vaccine

    Throughout study

Secondary Outcomes (7)

  • To compare antibody responses

    At Days 28 and 42

  • To determine the number of vaccinees infected with the H9N2 G9/AA ca reassortant vaccine candidate.

    Throughout study

  • If 10^7 , 10^5 , and 10^3 TCID50 doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups, and to estimate the HID50 for this vaccine

    Throughout study

  • To determine the phenotypic stability of vaccine virus shed

    Throughout study

  • To determine whether immunogenicity is enhanced by a second dose of vaccine, and whether the first dose of vaccine restricts replication of the second dose

    At study completion

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

One vaccination 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.

Biological: H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)

2

EXPERIMENTAL

One vaccination 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. This Arm will enroll 4 weeks after Arm 1. Enrolled volunteers must have participated in Arm 1.

Biological: H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)

Interventions

H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)BIOLOGICAL

Live attenuated H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Born after 1968
  • Good general health
  • Available for the duration of the trial

You may not qualify if:

  • Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
  • Liver, renal, or hematologic disease
  • Alcohol or drug abuse within 12 months of study entry
  • History of severe allergic reaction or anaphylaxis
  • Current asthma or reactive airway disease
  • History of Guillain-Barre syndrome
  • HIV-1 infected
  • Hepatitis C virus infected
  • Positive for hepatitis B surface antigen (HBsAg)
  • Known immunodeficiency syndrome
  • Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical corticosteroids are not excluded.
  • Live vaccine within 4 weeks of study entry
  • Killed vaccine within 2 weeks of study entry
  • Absence of spleen
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (5)

  • Chen H, Matsuoka Y, Swayne D, Chen Q, Cox NJ, Murphy BR, Subbarao K. Generation and characterization of a cold-adapted influenza A H9N2 reassortant as a live pandemic influenza virus vaccine candidate. Vaccine. 2003 Oct 1;21(27-30):4430-6. doi: 10.1016/s0264-410x(03)00430-4.

    PMID: 14505926BACKGROUND

  • 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.

    PMID: 15280470BACKGROUND

  • Stephenson I, Nicholson KG, Wood JM, Zambon MC, Katz JM. Confronting the avian influenza threat: vaccine development for a potential pandemic. Lancet Infect Dis. 2004 Aug;4(8):499-509. doi: 10.1016/S1473-3099(04)01105-3.

    PMID: 15288823BACKGROUND

  • Swayne DE. Vaccines for List A poultry diseases: emphasis on avian influenza. Dev Biol (Basel). 2003;114:201-12.

    PMID: 14677690BACKGROUND

  • Karron RA, Callahan K, Luke C, Thumar B, McAuliffe J, Schappell E, Joseph T, Coelingh K, Jin H, Kemble G, Murphy BR, Subbarao K. A live attenuated H9N2 influenza vaccine is well tolerated and immunogenic in healthy adults. J Infect Dis. 2009 Mar 1;199(5):711-6. doi: 10.1086/596558.

    PMID: 19210163DERIVED

MeSH Terms

Conditions

Influenza, HumanVirus DiseasesInfluenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsRespiratory Tract DiseasesBird DiseasesAnimal Diseases

Study Officials

  • Ruth A. Karron, MD

    Center of Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

May 5, 2005

First Posted

May 6, 2005

Study Start

June 1, 2005

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

January 21, 2008

Record last verified: 2008-01

Locations

US(1)