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

NCT03132311 | Recruiting Phase 4

• 1 other identifier: 001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

yellow fever vaccine; hiv

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• Viremia

  7 days after the vaccine

• Adverse events

  up to 30 days after the vaccine

• Immunogenicity

  5 years after the vaccine

• Immunogenicity

  10 years after the vaccine

Study Arms (2)

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)

Biological: Yellow Fever vaccination (17 DD Biomanguinhos)

HIV negative subjects

ACTIVE COMPARATOR

100 HIV negative adults. Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos)

Biological: Yellow Fever vaccination (17 DD Biomanguinhos)

Interventions

Yellow Fever vaccination (17 DD Biomanguinhos) BIOLOGICAL

One intramuscular injection

HIV negative subjects; HIV positive subjects

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HIV infected adults, age \>= 18 and \<60 years old.
• Healthy HIV-uninfected individuals (aged \>= 18 and \< 60)
• No history of Yellow Fever vaccination
• Willing to participate and to sign the consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead

Study Sites (1)

Instituto Nacional de Infectologia Evandro Chagas

Rio de Janeiro, 21040360, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 37952362 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.

  PMID: 37650759 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Central Study Contacts

Lara E Coelho, MD

CONTACT

+552122707064; lara.coelho@ini.fiocruz.br

Beatriz Grinsztejn, MD

CONTACT

+552122707064; gbeatriz@ini.fiocruz.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: May 29, 2017
• Primary Completion: December 1, 2018
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)