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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Center for Immunization Research (CIR) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00347672 |
Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and other parts of the world. The need for a vaccine to prevent the spread of AI among livestock and to humans is sorely needed. The purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults.
Condition | Intervention | Phase |
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Influenza Virus Diseases |
Biological: H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | Phase 1 Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca), a Live Attenuated Virus Vaccine Candidate for the Prevention of Avian Influenza H5N1 Infection in the Event of a Pandemic |
Enrollment: | 42 |
Study Start Date: | June 2006 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Two vaccinations of H5N1 VN 2004/AA vaccine at the highest dose
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Biological: H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca)
Live, attenuated recombinant H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca) vaccine (one of three doses)
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2: Experimental
One vaccination of H5N1 VN 2004/AA vaccine at a dose in-between the lowest and highest doses
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Biological: H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca)
Live, attenuated recombinant H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca) vaccine (one of three doses)
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3: Experimental
One vaccination of H5N1 VN 2004/AA vaccine at the lowest dose
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Biological: H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca)
Live, attenuated recombinant H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca) vaccine (one of three doses)
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AI viruses in their natural reservoir in waterfowl are the source from which novel HA and NA subtypes are introduced into the human population, and have the potential to initiate an influenza pandemic. This study will evaluate the safety and immunogenicity of a live, attenuated recombinant AI virus vaccine, H5N1 (6-2) AA Ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/Ca).
Participants in this study will receive one or two doses of the vaccine. There are 3 groups in this study:
Group 1 will enroll first, probably in 2006. Groups 2 and 3 will not enroll until it is determined by safety review that the vaccine is well-tolerated and greater than 80% of Group 1 participants shed vaccine virus or develop a specific immune response to the vaccine.
Participation in this study includes a hospital stay in an isolation unit of the Bayview Medical Center of Johns Hopkins University. All participants will receive the vaccine at study entry and will remain in the isolation unit for a minimum of 14 days after vaccination. A physical exam and a nasal wash will occur daily in the isolation unit until a participant is discharged from the hospital. Participants will be allowed to leave the unit once viral cultures for influenza from nasal washes are negative for at least 3 consecutive days beginning on Day 10. Blood collection will occur at study entry, Day 7, sometime between Days 28 and 35, and sometime between Days 56 and 63.
There will be two separate hospitalizations for Group 1 participants. Group 1 participants will receive their doses of vaccine at study entry and sometime between Days 28 and 35. A physical exam and a nasal wash will occur daily in the isolation unit until a participant is discharged from the hospital. Participants will be allowed to leave the unit once viral cultures for influenza from nasal washes are negative for at least 3 consecutive days beginning on Day 10. Blood collection will occur at 4 or 5 selected timepoints, depending on the timing of the second vaccination.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Center of Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health | |
Baltimore, Maryland, United States, 21205 |
Principal Investigator: | Ruth A. Karron, MD | Center of Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health |
Responsible Party: | Center for Immunization Research (CIR), Johns Hopkins School of Public Health ( Ruth Karron, MD ) |
Study ID Numbers: | CIR 217, H.22.05.07.22.A2 |
Study First Received: | July 3, 2006 |
Last Updated: | January 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00347672 |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
Bird Flu |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human |
Influenza in Birds Healthy Orthomyxoviridae Infections |
RNA Virus Infections |