Influenza Clinical Trial
Official title:
Phase 1 Inpatient Study of the Safety and Immunogenicity 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 the 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 infecting people is important. The purpose of this study is to determine the safety of and immune response to a new AI vaccine in healthy adults against the H7N3 strain of avian influenza.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
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 - 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 - 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. - 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, Asia, or the United Kingdom 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 - 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 Inpatient Unit, Mason F. Lord Building, 4940 Eastern Avenue | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Johns Hopkins Bloomberg School of Public Health |
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
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 | Safety, defined as the frequency of vaccine-related reactogenicity events that occur during the acute monitoring (inpatient) phase of the study | Daily for 9 days after vaccination | Yes | |
Primary | Immunogenicity, determined by anti-H7N3 antibody titer | Before the first vaccination, 28 days after the first vaccination but before the second vaccination, and 28 days after the second vaccination | No | |
Primary | Quantifying the amount of vaccine virus shed by each recipient; and determining the amount of serum and nasal wash antibody induced by the vaccine | Daily for 9 days after vaccination | No | |
Secondary | To determine the number of vaccinees infected with the vaccine virus | Daily for 8 days after each vaccination | No | |
Secondary | To determine the phenotypic stability of the vaccine virus | Throughout study | No | |
Secondary | To determine whether immunogenicity is enhanced by a second dose of vaccine | At study completion | No | |
Secondary | To evaluate T-cell mediated and innate immune responses against the vaccine virus | Throughout study | No | |
Secondary | To develop a serum bank to evaluate future H7 influenza vaccines | Throughout study | No |
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