Influenza Clinical Trial
Official title:
Phase 1 Inpatient Study of the Safety and Immunogenicity of One Dose of Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/Chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H7N3 Infection in the Event of a Pandemic
Over the past decade, avian influenza (AI) has become a major health concern. The development of safe and effective vaccines against avian strains that infect people is important. The purpose of this study is to determine the safety of and immune response of an investigational AI vaccine in healthy adults against the H7N3 strain of avian influenza.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2011 |
Est. primary completion date | August 2011 |
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 trial - For females, willing to use acceptable forms of contraception for the duration of the study. More information on this criterion can be found in the protocol. 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 - Previously enrolled in an H7N3 influenza vaccine trial or in any study of an avian influenza vaccine - Seropositive to the H7N3 influenza A virus (serum hemagglutination inhibition [HI] titer greater than 1:8) - Illegal drug use or dependency determined by urine test - Medical, work, or family problems as a result of alcohol or illicit drug use within 12 months prior to study entry - 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 corticosteroids or immunosuppressive drugs within 30 days prior to vaccination. Participants who have used topical corticosteroids are not excluded. - Receipt of live vaccines within 4 weeks prior to study vaccination - Receipt of killed vaccines within 2 weeks prior to study vaccination - Absence of spleen - Receipt of 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 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 within 14 days prior to or after study vaccination - Other investigational vaccine or drug within 30 days prior to study vaccination - Allergy to eggs or egg products - Other condition that, in the opinion of the investigator, may interfere with 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 | University of Rochester Vaccine Evaluation Isolation Unit, St. Mary's Hospital | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Alexander DJ. Avian influenza viruses and human health. Dev Biol (Basel). 2006;124:77-84. Review. — View Citation
Joseph T, McAuliffe J, Lu B, Jin H, Kemble G, Subbarao K. Evaluation of replication and pathogenicity of avian influenza a H7 subtype viruses in a mouse model. J Virol. 2007 Oct;81(19):10558-66. Epub 2007 Jul 18. — View Citation
Joseph T, McAuliffe J, Lu B, Vogel L, Swayne D, Jin H, Kemble G, Subbarao K. A live attenuated cold-adapted influenza A H7N3 virus vaccine provides protection against homologous and heterologous H7 viruses in mice and ferrets. Virology. 2008 Aug 15;378(1):123-32. doi: 10.1016/j.virol.2008.05.021. Epub 2008 Jun 27. — View Citation
Skowronski DM, Li Y, Tweed SA, Tam TW, Petric M, David ST, Marra F, Bastien N, Lee SW, Krajden M, Brunham RC. Protective measures and human antibody response during an avian influenza H7N3 outbreak in poultry in British Columbia, Canada. CMAJ. 2007 Jan 2;176(1):47-53. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of vaccine-related reactogenicity events | During inpatient stage | Yes | |
Primary | Area under the curve of nasal viral shedding | Days 2 through 9 | No | |
Primary | Development of serum antibody assessed by either HAI or MN assays | Throughout study | No | |
Secondary | Number of participants infected with the recombinant vaccine candidate | Throughout study | No | |
Secondary | T-cell mediated and innate immune responses against recombinant vaccine candidate | Throughout study | No | |
Secondary | Development of serum bank for testing effectiveness of vaccine against future viruses | Throughout study | No |
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