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NCT Number: NCT03132311

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

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.

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Key information

Conditions

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

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Nacional de Infectologia Evandro Chagas

Rio de Janeiro, 21040360, Brazil

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yellow Fever vaccination (17 DD Biomanguinhos)

Biological

One intramuscular injection

Primary outcomes

  1. Immunogenicity

    Time frame: 30 days after the vaccine

    Seroconversion

  2. Immunogenicity

    Time frame: 30 days after the vaccine

    Neutralizing antibodies titers

  3. Immunogenicity

    Time frame: 365 days after the vaccine

    Seroconversion

  4. Immunogenicity

    Time frame: 365 days after the vaccine

    Neutralizing antibodies titers

Secondary outcomes

  1. Viremia

    Time frame: 7 days after the vaccine

    Yellow Fever vaccine viremia

  2. Adverse events

    Time frame: up to 30 days after the vaccine

    Yellow Fever vaccine related adverse events

  3. Immunogenicity

    Time frame: 5 years after the vaccine

    Neutralizing antibodies titles

  4. Immunogenicity

    Time frame: 10 years after the vaccine

    Neutralizing antibodies titles

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Oswaldo Cruz Foundation

Other

Registry information

Acronym: YF-HIV

Important dates

Study start
2017
Primary completion
2018
Study completion
2028
First posted
Apr 27, 2017
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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