A Phase 1 interventional study of H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca) in Influenza and Virus Diseases, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-11-20.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention
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.
According to the World Health Organization, the current pandemic risk associated with avian influenza H5N1 infection is serious, as an increasing number of humans are infected. Currently, H5N1 influenza transmission occurs in humans when they are exposed through direct contact to infected poultry or surfaces and objects contaminated by infected poultry feces. A pandemic occurs when a new influenza subtype emerges that infects humans, causes serious illness, and spreads easily among humans. The development of a safe and effective vaccine is necessary, should a pandemic occur. The purpose of this study is to evaluate the safety and immunogenicity of a live, attenuated A1 virus vaccine, H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca).
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.
914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.
This study's enrollment of 16 is below the median of 102 across 604 interventional studies indexed under Virus Diseases.
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Exclusion Criteria:
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
Biological: H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca)
Intranasal vaccine
Safety, defined as the frequency of vaccine-related reactogenicity events
Time frame: During the acute monitoring (in-patient) phase of the study
Immunogenicity, determined by anti-H5N1 antibody titer
Time frame: At Days 0, 7, 9, and 28 with respect to vaccination
This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)