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| ID | Type | Description | Link |
|---|---|---|---|
| HSRRB No. A-15223 | Other Identifier | Human Subjects Research Review Board |
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This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous prime boost regimen 1 | Active Comparator | FluMistĀ® live intranasal vaccine (LAIV) 0.2mL (0.1mL per nostril): 2 doses separated by 8 weeks (+/- 7 days) |
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| Autologous prime boost regimen 2 | Active Comparator | FluzoneĀ® inactivated seasonal influenza virus vaccine intramuscularly: 2 doses separated by 8 weeks (+7 days) |
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| Heterologous prime boost regimen 1 | Experimental | FluMistĀ® live, intranasal vaccine single dose, followed by FluzoneĀ® inactivated influenza virus vaccine 8 weeks (+/-7 days) later |
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| Heterologous prime boost regimen 2 | Experimental | FluzoneĀ® inactivated seasonal influenza virus vaccine single dose, followed by FluMistĀ® live, intranasal seasonal influenza vaccine 0.2mL 8 weeks (+/- 7 days) later |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluMistĀ® live, attenuated, intranasal seasonal influenza vaccine | Biological | FluMistĀ® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril) |
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| Measure | Description | Time Frame |
|---|---|---|
| antibody titers | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| safety of 2 doses of seasonal influenza vaccine in healthy adults | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Delia B Bethell, BM BCh | Armed Forces Research Institute of Medical Sciences, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States Embassy Medical Unit | Bangkok | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23555741 | Result | Bethell D, Saunders D, Jongkaewwattana A, Kramyu J, Thitithayanont A, Wiboon-ut S, Yongvanitchit K, Limsalakpetch A, Kum-Arb U, Uthaimongkol N, Garcia JM, Timmermans AE, Peiris M, Thomas S, Engering A, Jarman RG, Mongkolsirichaikul D, Mason C, Khemnu N, Tyner SD, Fukuda MM, Walsh DS, Pichyangkul S. Evaluation of in vitro cross-reactivity to avian H5N1 and pandemic H1N1 2009 influenza following prime boost regimens of seasonal influenza vaccination in healthy human subjects: a randomised trial. PLoS One. 2013;8(3):e59674. doi: 10.1371/journal.pone.0059674. Epub 2013 Mar 26. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| FluzoneĀ® inactivated influenza virus vaccine | Biological | FluzoneĀ® inactivated influenza virus vaccine 0.5mL intramuscularly |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |