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

HIV Infections Clinical Trial

— YF-HIV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03132311
• Other study ID #: 001
• Status: Recruiting
• Phase: Phase 4
• Start date: May 29, 2017
• Est. completion date: December 2028

Study information

• Verified date: July 2018
• Source: Oswaldo Cruz Foundation
• Contact: Lara E Coelho, MD
• Phone: +552122707064
• Email: lara.coelho[@]ini.fiocruz.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2028
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Yellow Fever

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto Nacional de Infectologia Evandro Chagas	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Oswaldo Cruz Foundation

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity	Seroconversion	30 days after the vaccine
Primary	Immunogenicity	Neutralizing antibodies titers	30 days after the vaccine
Primary	Immunogenicity	Seroconversion	365 days after the vaccine
Primary	Immunogenicity	Neutralizing antibodies titers	365 days after the vaccine
Secondary	Viremia	Yellow Fever vaccine viremia	7 days after the vaccine
Secondary	Adverse events	Yellow Fever vaccine related adverse events	up to 30 days after the vaccine
Secondary	Immunogenicity	Neutralizing antibodies titles	5 years after the vaccine
Secondary	Immunogenicity	Neutralizing antibodies titles	10 years after the vaccine