Influenza Clinical Trial
Official title:
Phase I Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine Modified H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H5N1 Infection in the Event of a Pandemic
Over the past decade, avian influenza (AI) has become a major health concern. The development of a safe and effective vaccine against H5N1 infection is important. The purpose of this study is to determine the safety of a new AI vaccine in healthy adults.
Status | Completed |
Enrollment | 16 |
Est. completion date | September 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - Good general health - Available for the duration of the study - Willing to use acceptable forms of contraception for the duration of the study Exclusion Criteria: - Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Center for Immunization Research (CIR), Johns Hopkins Bloomberg 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,
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. Epub 2007 Jun 1. Review. — View Citation
Cox MM. Vaccines in development against avian influenza. Minerva Med. 2007 Apr;98(2):145-53. Review. — View Citation
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. — View Citation
Rajagopal S, Treanor J. Pandemic (avian) influenza. Semin Respir Crit Care Med. 2007 Apr;28(2):159-70. Review. — View Citation
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. Epub 2005 Jan 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety, defined as the frequency of vaccine-related reactogenicity events | During the acute monitoring (in-patient) phase of the study | ||
Secondary | Immunogenicity, determined by anti-H5N1 antibody titer | At Days 0, 7, 9, and 28 with respect to vaccination |
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