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Phase 4 study to evaluate the immunogenicity and Safety of the 17DD Yellow Fever vaccine in HIV infected individuals, compared to non-HIV-infected individuals.
Main objective:
To compare the proportion of seroconversion and the geometric mean of neutralizing antibodies 30 days and 365 days after vaccine.
Secondary objectives:
To evaluate whether the titles of neutralizing antibodies are associated with CD4 lymphocyte counts, CD8 lymphocyte counts, CD4 nadir, HIV viral load and use of antiretroviral therapy. To assess the yellow fever vaccine viremia at day 10 after vaccine.To compare the incidence of adverse events in HIV-infected and non-HIV-infected individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV positive subjects | Experimental | 300 HIV positive adults with CD4 > 200 cells/mm3, stratified in 3 groups (100 patients in each group) according to CD4 counts (200-350; 351-500, >500 cells/mm3). Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos) |
|
| HIV negative subjects | Active Comparator | 100 HIV negative adults. Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yellow Fever vaccination (17 DD Biomanguinhos) | Biological | One intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Seroconversion | 30 days after the vaccine |
| Immunogenicity | Neutralizing antibodies titers | 30 days after the vaccine |
| Immunogenicity | Seroconversion | 365 days after the vaccine |
| Immunogenicity | Neutralizing antibodies titers | 365 days after the vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Viremia | Yellow Fever vaccine viremia | 7 days after the vaccine |
| Adverse events | Yellow Fever vaccine related adverse events | up to 30 days after the vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lara E Coelho, MD | Contact | +552122707064 | lara.coelho@ini.fiocruz.br | |
| Beatriz Grinsztejn, MD | Contact | +552122707064 | gbeatriz@ini.fiocruz.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Infectologia Evandro Chagas | Recruiting | Rio de Janeiro | 21040360 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37952362 | Derived | Macieira KV, Caetano DG, De Lima SMB, Wagner Giacoia-Gripp CB, Cortes FH, Da Silva Cazote A, De Souza Azevedo Soares A, Dos Santos Alves N, De Souza Borges Quintana M, Costa M, Brandao LGP, De Andrade MM, Grinsztejn B, Coelho LE, De Almeida DV. Differential gene expression of cytokines, receptors, and miRNAs in individuals living with HIV-1 and vaccinated against yellow fever. Mol Immunol. 2023 Dec;164:58-65. doi: 10.1016/j.molimm.2023.10.013. Epub 2023 Nov 10. | |
| 37650759 |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Immunogenicity | Neutralizing antibodies titles | 5 years after the vaccine |
| Immunogenicity | Neutralizing antibodies titles | 10 years after the vaccine |
| Derived |
| Motta E, Camacho LAB, Cunha M, de Filippis AMB, Lima SMB, Costa M, Pedro L, Cardoso SW, Cortes FH, Giacoia-Gripp CBW, Morata M, Nazer S, Moreira RI, de Oliveira Souza MC, Mendes YS, Souza Azevedo A, Dos Santos Alvez N, Grinsztejn B, Coelho LE. Immunogenicity and reactogenicity of yellow fever vaccine in people with HIV. AIDS. 2023 Dec 1;37(15):2319-2329. doi: 10.1097/QAD.0000000000003696. Epub 2023 Aug 23. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |