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

Overview

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.

Interventions

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

Primary outcome measures

• Immunogenicity [Time frame: 30 days after the vaccine]
• Immunogenicity [Time frame: 30 days after the vaccine]
• Immunogenicity [Time frame: 365 days after the vaccine]
• Immunogenicity [Time frame: 365 days after the vaccine]

Secondary outcome measures (4)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Brazil · 1 center

• Instituto Nacional de Infectologia Evandro Chagas — Rio de Janeiro

Publications

• 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

Identifiers

NCT: NCT03132311 · 001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗