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

Who is this study for? Patients with Human Immunodeficiency Virus
What treatments are being studied? Yellow Fever Vaccination (17 DD Biomanguinhos)
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 59
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Brazil
Instituto Nacional de Infectologia Evandro Chagas
RECRUITING
Rio De Janeiro
Contact Information
Primary
Lara E Coelho, MD
lara.coelho@ini.fiocruz.br
+552122707064
Backup
Beatriz Grinsztejn, MD
gbeatriz@ini.fiocruz.br
+552122707064
Time Frame
Start Date: 2017-05-29
Estimated Completion Date: 2028-12
Participants
Target number of participants: 400
Treatments
Experimental: HIV positive subjects
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)
Active_comparator: HIV negative subjects
100 HIV negative adults.~Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos)
Sponsors
Leads: Oswaldo Cruz Foundation

This content was sourced from clinicaltrials.gov

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