Single Group Study of the Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults
NCT ID: NCT00488046
Last Updated: 2007-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2007-06-30
2007-09-30
Brief Summary
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Detailed Description
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This study will last approximately 16 weeks. Participation in this study includes a hospital stay 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 will occur daily following each vaccination until discharge. Participants will not be discharged until nasal washes are negative. Vital signs measurement will be done at least twice daily for the duration of the inpatient stay. A follow-up outpatient visit will occur approximately 4 weeks following each vaccination. Blood and urine collection will occur at selected timepoints throughout the study.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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1
Two, 0.5 ml doses of vaccine in nasal spray form administered at study entry and sometime between 4 and 8 weeks after initial vaccination
H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca)
Intranasal vaccine
Interventions
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H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca)
Intranasal vaccine
Eligibility Criteria
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Inclusion Criteria
* Available for the duration of the study
* Willing to use acceptable forms of contraception for the duration of the study
Exclusion Criteria
* Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may affect study participation
* Medical, work, or family problems as a result of alcohol or illicit drug use within 12 months prior to study entry
* Previously enrolled in an H5N1 influenza vaccine trial or in any study of an avian influenza vaccine
* Seropositive to the H5N1 influenza A virus (serum hemagglutination inhibitor \[HI\] titer greater than 1:8)
* Illegal drug use or dependency determined by urine test
* 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 corticosteroid 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 or Asia 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-related condition
* Other condition that, in the opinion of the investigator, may interfere with the study
* Pregnancy or breastfeeding
18 Years
49 Years
ALL
Yes
Sponsors
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Johns Hopkins Bloomberg School of Public Health
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Ruth A. Karron, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
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Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States
Countries
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References
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Cinatl J Jr, Michaelis M, Doerr HW. The threat of avian influenza A (H5N1). Part IV: Development of vaccines. Med Microbiol Immunol. 2007 Dec;196(4):213-25. doi: 10.1007/s00430-007-0052-3. Epub 2007 Jun 1.
Cox MM. Vaccines in development against avian influenza. Minerva Med. 2007 Apr;98(2):145-53.
Peiris JS, Yu WC, Leung CW, Cheung CY, Ng WF, Nicholls JM, Ng TK, Chan KH, Lai ST, Lim WL, Yuen KY, Guan Y. Re-emergence of fatal human influenza A subtype H5N1 disease. Lancet. 2004 Feb 21;363(9409):617-9. doi: 10.1016/S0140-6736(04)15595-5.
Rajagopal S, Treanor J. Pandemic (avian) influenza. Semin Respir Crit Care Med. 2007 Apr;28(2):159-70. doi: 10.1055/s-2007-976488.
Ungchusak K, Auewarakul P, Dowell SF, Kitphati R, Auwanit W, Puthavathana P, Uiprasertkul M, Boonnak K, Pittayawonganon C, Cox NJ, Zaki SR, Thawatsupha P, Chittaganpitch M, Khontong R, Simmerman JM, Chunsutthiwat S. Probable person-to-person transmission of avian influenza A (H5N1). N Engl J Med. 2005 Jan 27;352(4):333-40. doi: 10.1056/NEJMoa044021. Epub 2005 Jan 24.
Karron RA, Talaat K, Luke C, Callahan K, Thumar B, Dilorenzo S, McAuliffe J, Schappell E, Suguitan A, Mills K, Chen G, Lamirande E, Coelingh K, Jin H, Murphy BR, Kemble G, Subbarao K. Evaluation of two live attenuated cold-adapted H5N1 influenza virus vaccines in healthy adults. Vaccine. 2009 Aug 6;27(36):4953-60. doi: 10.1016/j.vaccine.2009.05.099. Epub 2009 Jun 21.
Related Links
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Click here for the Johns Hopkins Bloomberg School of Public Health - Center for Immunization Research (CIR) Web site
Other Identifiers
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CIR 239
Identifier Type: -
Identifier Source: org_study_id