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| Name | Class |
|---|---|
| Hospital Universitario da USP | UNKNOWN |
| University of Sao Paulo | OTHER |
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This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.
The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pandemic vaccine 1 | Experimental | 7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3 |
|
| pandemic vaccine 2 | Experimental | 3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3 |
|
| pandemic vaccine 5 | Experimental | 7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion |
|
| pandemic vaccine 6 | Experimental | 3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion |
|
| pandemic vaccine 9 | Experimental | 7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion |
|
| pandemic vaccine 10 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pandemic vaccine 1 | Biological | 7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay | Volunteers will receive two doses of vaccine,21 days apart. | 21 days after each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Evaluation of local and systemic adverse effects throught the study period | 30 minutes and 72 hours after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucia MA Campos, MD. PhD | Children´s Institute - School of Medicine of University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP | São Paulo | São Paulo | 05403-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21945258 | Derived | Precioso AR, Miraglia JL, Campos LM, Goulart AC, Timenetsky Mdo C, Cardoso MR, Luna E, Mondini G, Guedes Jda S, Raw I. A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems. Vaccine. 2011 Nov 8;29(48):8974-81. doi: 10.1016/j.vaccine.2011.09.040. Epub 2011 Sep 21. |
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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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| ID | Term |
|---|---|
| C488512 | hexavalent group A streptococcal vaccine |
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3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
|
| pandemic vaccine 11 | Experimental | 7,5µg of A/H1N1 with Al(OH)3 |
|
| pandemic vaccine 12 | Experimental | 3,75µg of A/H1N1 with Al(OH)3 |
|
| pandemic vaccine 13 | Experimental | 15µg of A/H1N1 with no adjuvant |
|
| placebo group 14 | Placebo Comparator | placebo |
|
| pandemic vaccine 2 | Biological | 3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3 |
|
|
| pandemic vaccine 5 | Biological | 7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion |
|
|
| pandemic vaccine 6 | Biological | 3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion |
|
|
| pandemic vaccine 9 | Biological | 7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion |
|
|
| pandemic vaccine 10 | Biological | 3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion |
|
|
| pandmeic vaccine 11 | Biological | 7,5µg of A/H1N1 with Al(OH)3 |
|
|
| pandmeic vaccine 12 | Biological | 3,75µg of A/H1N1 with Al(OH)3 |
|
|
| pandmic vaccine 13 | Biological | 15µg of A/H1N1 with no adjuvant |
|
|
| placebo group 14 | Biological | All elements of the vaccine but antigen and adjuvant |
|
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| Centro de Pesquisa Clínica do Hospital Universitário da USP | São Paulo | São Paulo | 05508000 | Brazil |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |