Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals

Обзор

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.

Вмешательства

• Биопрепарат Yellow Fever vaccination (17 DD Biomanguinhos)
  One intramuscular injection

Первичные конечные точки

• Immunogenicity [Срок оценки: 30 days after the vaccine]
• Immunogenicity [Срок оценки: 30 days after the vaccine]
• Immunogenicity [Срок оценки: 365 days after the vaccine]
• Immunogenicity [Срок оценки: 365 days after the vaccine]

Вторичные конечные точки (4)

• Viremia [Срок оценки: 7 days after the vaccine]
• Adverse events [Срок оценки: up to 30 days after the vaccine]
• Immunogenicity [Срок оценки: 5 years after the vaccine]
• Immunogenicity [Срок оценки: 10 years after the vaccine]

Критерии участия

Критерии включения

• HIV infected adults, age >= 18 and <60 years old.
• CD4 > 200 cells/mm³ within the last 6 months prior to inclusion. Individuals with no CD4 results in the last 6 months which have undetectable HIV viral load and last CD4 count > 350 can be included.
• Healthy HIV-uninfected individuals (aged >= 18 and < 60)
• No history of Yellow Fever vaccination
• Willing to participate and to sign the consent

Критерии исключения

• Individuals with chronic diseases such as: decompensated diabetes, kidney failure (in dialysis), liver failure/cirrhosis, cancer (except for non-melanoma skin cancer and in situ HIV related carcinoma), use of immunosuppressive agents (including prednisone ≥ 20mg/day, during 7 or more days in the last 30 days before inclusion).
• Pregnant women
• Hypersensitivity reaction to eggs, chicken protein. Allergy to erythomycin or kanamycin. Hereditary fructose intolerance.
• Administration of immunoglobulins or blood derivates < 3 months or life attenuated vaccine <1 month.
• History of thymic dysfunction (including thymoma and thymectomy).
• Use of anti-CCR5
• symptoms of severe acute illnesses or fever (axillary temperature ≥ 38°C)
• HIV positive rapid test for HIV negative subjects.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Бразилия · 1 центр

• Instituto Nacional de Infectologia Evandro Chagas — Rio de Janeiro

Публикации

• 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 De PMID 37952362
• 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 202 PMID 37650759

Идентификаторы

NCT: NCT03132311 · 001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗