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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI068632 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The purpose of this research study is to evaluate the immune response to the H1N1 influenza or "flu" vaccine. The "immune response" is how your body recognizes and defends itself against bacteria, viruses, and substances that may be harmful to the body.
HIV-1 infected children typically respond more poorly to vaccines compared to uninfected, healthy children and so this study hopes to learn whether or not the body will successfully produce enough antibodies (proteins that fight infection) that will prevent or fight the H1N1 flu virus. There is no information yet on the safety or immune response to this vaccine in children infected with HIV.
HIV-infected children typically respond poorer to vaccines as compared to normal children. The FDA has currently approved several Influenza A 2009 monovalent vaccines to be used in children and adults. However, little data is available in perinatally infected youth. Therefore, knowledge of the immunogenicity of several of the licensed Influenza A 2009 monovalent vaccines in HIV-infected children and youth is critically important to address the health care needs of this vulnerable population. Efforts are currently underway to evaluate Influenza A 2009 monovalent vaccines in healthy children as well as other populations. This study will assess the immune response following receipt of three Influenza A monovalent vaccines in HIV-1 infected children and youth. Protection of HIV-1 infected children and youth from 2009 H1N1 Influenza A will require knowledge of immunogenicity of these new products in this population. The 2009 (H1N1) Influenza A virus is likely to infect a significant proportion of HIV-1 infected children and youth. Immunogenicity of licensed and commercially available Influenza A 2009 monovalent vaccines must be established in HIV-1 infected children in order to assure that this population is protected. Lack of a protective immune response would support the need for additional measures to protect this high risk population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Influenza A 2009 Monovalent vaccine |
| |
| Group B | Influenza A 2009 monovalent vaccine |
| |
| Group C | Influenza A 2009 monovalent vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluMist | Biological | Administered at the manufacture's recommended dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The short term immune response following immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine administered as a single dose in perinatally HIV-1 infected children and youth aged >10 to <25 years. | 8 months | |
| The short term immune response following second immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine in perinatally HIV-1 infected children > 6 months to < 10 years of age. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| The immune response following first immunization with a licensed Influenza A (H1N1) 2009 monovalent vaccine in children aged > 6 months to < 10 years of age. | 8 months | |
| Persistence of antibody responses 7 months after receipt of the first immunization with a licensed Influenza A (H1N1) 2009 monovalent vaccine. |
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Inclusion Criteria:
Children and youth 6 months to <25 years of age at study entry.
HIV infection, defined as positive test results obtained from 2 different samples. Tests may include two of the same type OR two different types of tests listed below, as long as there are positive test results obtained from 2 different samples:
In the opinion of the investigator, the route of HIV-1 transmission is perinatally acquired.
Parent or legal guardian, youth of legal age, or subjects who are emancipated minors, who are willing and able to provide signed informed consent.
Planned receipt of one of the following FDA licensed Influenza A (H1N1) 2009 Monovalent Vaccines within 24 hours following study entry:
Exclusion Criteria:
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HIV-1 perinatally infected children and youth 6 months to 25 years of age.
For inclusion into the study, if perinatal acquisition of HIV infection cannot be confirmed based on the child's medical record, it is acceptable to enroll the child if the investigator's assessment is that the most likely route of infection was perinatal.
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| Name | Affiliation | Role |
|---|---|---|
| Patricia M. Flynn, M.D. | St. Jude Childrens Research Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ. of Alabama Birmingham NICHD CRS (5096) | Birmingham | Alabama | 35294 | United States | ||
| USC/Los Angeles County Medical Center NICHD CRS |
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| Fluvirin |
| Biological |
Vaccine administered at the manufacturer's recommended dose. |
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| Fluzone | Biological | Vaccine administered at manufacturer's recommended dose |
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| 8 months |
| Immune responses with CD4+ cell count and timing of seasonal trivalent influenza vaccine (TIV). | 8 months |
| Immune responses with CD4 percent and timing of seasonal trivalent influenza vaccine (TIV). | 8 months |
| Immune responses with ARV use and timing of seasonal trivalent influenza vaccine (TIV). | 8 months |
| Immune responses with plasma HIV-1 RNA concentration and timing of seasonal trivalent influenza vaccine (TIV). | 8 months |
| Los Angeles |
| California |
| 90033 |
| United States |
| University of California San Francisco NICHD CRS (5091) | San Francisco | California | 94143 | United States |
| University of Colorado Denver NICHD CRS (5052) | Aurora | Colorado | 80045 | United States |
| University of Miami Pediatric/Perinatal HIV/AIDS (4201) | Miami | Florida | 33136 | United States |
| University of South Florida Tampa (5018) | Tampa | Florida | 33620 | United States |
| Chicago Children's CRS (4001) | Chicago | Illinois | 60614 | United States |
| Children's Hospital of Boston NICHD CRS (5009) | Boston | Massachusetts | 02115 | United States |
| WNE Maternal Pediatric Adolescent AIDS CRS | Worcester | Massachusetts | 01605 | United States |
| Wayne State University/Children's Hospital of Michigan NICHD CRS | Detroit | Michigan | 48201 | United States |
| NJ Med School CRS (2802) | Newark | New Jersey | 07103 | United States |
| New York University NY (5012) | New York | New York | 10016 | United States |
| SUNY Stony Brook (5040) | Stony Brook | New York | 11794-8111 | United States |
| Jacobi Medical Center Bronx (5013) | The Bronx | New York | 10461 | United States |
| The Children's Hospital of Philadelphia (6701) | Philadelphia | Pennsylvania | 19104 | United States |
| St. Jude/UTHSC CRS (6501) | Memphis | Tennessee | 38105-2794 | United States |
| University of Puerto Rico Pediatric HIV/AIDS Research (6601) | San Juan | 00936-5067 | Puerto Rico |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000613429 | FluMist |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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