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

NCT00380237 | Completed Phase 1

• 2 other identifiers: CIR 211 (Study B)CHR H.22.05.03.11.B2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; Virus Diseases

Keywords

Bird Flu; Avian Flu

Outcome Measures

Primary Outcomes (3)

• Safety, as defined by frequency of vaccine-related reactogenicity events and other adverse events (AEs) for each dose

  Throughout study

• Immunogenicity, as determined by antibody to H9N2

  At Days 0, 28, and 42

• Determining the amount of serum and nasal wash antibody induced by the vaccine

  Throughout study

Secondary Outcomes (4)

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

  Throughout study

• To determine the phenotypic stability of vaccine virus shed

  Throughout study

• 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

  Throughout study

• To evaluate T-cell mediated and innate immune responses against the H9N2 G9/AA ca reassortant vaccine candidate

  Throughout study

Study Arms (1)

1

EXPERIMENTAL

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.

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

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

Baltimore, Maryland, 21224, United States

Location

Related Publications (4)

• 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: 15280470 BACKGROUND

• 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.

  PMID: 10774473 BACKGROUND

• 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.

  PMID: 16026813 BACKGROUND

• 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.

  PMID: 10920197 BACKGROUND

MeSH Terms

Conditions

Influenza, Human; Virus Diseases; Influenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases; Bird Diseases; Animal Diseases

Study Officials

• Ruth A. Karron, MD

  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: September 22, 2006
• First Posted: September 25, 2006
• Study Start: October 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: January 21, 2008

Record last verified: 2008-01

Locations

US (1)