Influenza Clinical Trial
Official title:
Phase I 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 A)
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2005 |
Est. primary completion date | September 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Born after 1968 - Good general health - Available for the duration of the trial Exclusion Criteria: - 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 - Blood products within 6 months of study entry - Current smoker - Have traveled to the Southern Hemisphere or Asia within 30 days prior to study entry - Have traveled on a cruise ship within 30 days prior to study entry - Work in the poultry industry - Investigational agents within 60 days prior to study entry, or currently participating in another investigational vaccine or drug trial - 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 the participant's participation in the study - Pregnant or breastfeeding |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins School of Public Health | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Johns Hopkins Bloomberg School of Public Health |
United States,
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. — View 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. — View Citation
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. Review. — View Citation
Swayne DE. Vaccines for List A poultry diseases: emphasis on avian influenza. Dev Biol (Basel). 2003;114:201-12. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of vaccine-related reactogenicity events and other adverse effects for each dose of the H9N2 G9/AA ca reassortant vaccine | Throughout study | Yes | |
Primary | Immunogenicity and infectivity for each dose of the H9N2 G9/AA ca reassortant vaccine | Throughout study | No | |
Secondary | To compare antibody responses | At Days 28 and 42 | No | |
Secondary | To determine the number of vaccinees infected with the H9N2 G9/AA ca reassortant vaccine candidate. | Throughout study | No | |
Secondary | 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 | No | |
Secondary | To determine the phenotypic stability of vaccine virus shed | Throughout study | No | |
Secondary | 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 | No | |
Secondary | To evaluate T-cell mediated and innate immune responses against the H9N2 G9/AA ca reassortant vaccine candidate | Throughout study | No | |
Secondary | 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 | No |
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