"Persistence of Neutralizing Antibodies Against Yellow Fever (YF) in HIV-infected Patients"

NCT03591003 | Completed

• 1 other identifier: B076201421922
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 12

Brief Summary

Participating countries: Belgium Context: In June 2013, WHO notified that "a single dose of YF vaccine is sufficient to confer sustained life-long protective immunity against YF disease and that a booster dose is not necessary". . For HIV infected persons the recommendation was less stringent and the position paper concluded that hiv infected persons may "hypothetically, benefit from a second dose or booster dose ".1 Recently, WHO changed the recommendations about a booster dose of YF vaccine, based on the fact that serum neutralizing antibodies against YF are still at detectable levels after 20-35 years and probably lifelong in immunocompetent patients. Unfortunately, data on persistence of Neutralizing antibodies Titers (NT) in immunocompromised patients are missing and only few studies reported data about HIV-infected patients. Additional data are needed. Primary objective: To assess presence / persistence of Neutralizing Titers (NT) of antibodies after YF immunization in HIV-infected patients. Secondary objectives:

• the screening and inclusion visit (single visit V1) to check the patient eligibility, sign informed consent, perform the biologic tests necessary for the study and answer the questionnaire
• whenever possible, an additional serum / plasma sample coming from serabank / plasmabank will be identified for each patient. This sample must have been taken during the year following YF immunization.
• data about patient's HIV history has to be extracted from the HIV database or from patients' file Estimated enrolment 750 patients + 30 patients infected vertically with HIV Primary outcome Number of HIV patients with protective YF NT ≥ 1:10 at different timepoints after YF immunization Secondary outcomes
• Number of patients with protective YF NT ≥ 1:10 in the year following YF immunization
• Risk factors (demographics and immunovirological parameters, antiretroviral treatment) for absence of seroconversion in the year following YF immunization
• Risk factors (demographics and immunovirological parameters, antiretroviral treatment) of early waning (before 10 years) of YF NT
• Risk factors (demographics and immunovirological parameters, antiretroviral treatment) of late waning (after 10 years) of YF NT Eligibility Inclusion criteria
• Whenever possible, an additional sera or plasma sample from the year following YF vaccine will be selected and analyzed to assess early seroconversion rate
• Whenever possible, an additional sera or plasma sample from the year before YF vaccine will be selected and analyzed to assess seroconversion rate
• In CHU Saint-Pierre, an additional cohort of patients infected vertically with HIV will be selected and will participate to the study

Conditions

HIV Infections; Yellow Fever Vaccine

Outcome Measures

Primary Outcomes (1)

• Number of HIV patients with protective YF NT ≥ 1:10 at different timepoints after YF immunization

  protective YF NT ≥ 1:10

  up to 60 years after YF vaccine administration

Secondary Outcomes (4)

• Number of patients with protective YF NT ≥ 1:10 in the year following YF immunization

  up to 1 year after YF immunization

• Risk factors for absence of seroconversion in the year following YF immunization

  up to 1 year after YF immunization

• Risk factors of early waning (before 10 years) of YF NT

  before 10 years after YF immunization

• Risk factors of late waning (after 10 years) of YF NT

  after 10 years up to 60 years after YF vaccine administration

Study Arms (1)

HIV-infected patients

HIV-infected patients vaccinated at least once in their life against yellow fever

Diagnostic Test: Yellow fever neutralizing antibodies measure

Interventions

Yellow fever neutralizing antibodies measure DIAGNOSTIC_TEST

Yellow fever neutralizing antibodies measure before vaccination, within the year after vaccination and at any delay after vaccination

HIV-infected patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SAMPLE SIZE Approximately 750 patients who meet the following inclusion criteria will be enrolled. Vertical transmission Substudy : Approximately 30 patients who meet the following inclusion criteria will be enrolled

You may qualify if:

• Infection with HIV-1 (vertically infected or not)
• Immunization with at least one injection of YF vaccine (Stamaril®,17D strain Rockefeller, Sanofi Pasteur) with proof of immunization
• Informed consent signed prior to any study procedure (for the Prospective part of the study )

You may not qualify if:

• Inability to give informed consent or incapacitation (for the Prospective part of the study)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (12)

Instituut voor Tropische Geneeskunde

Antwerp, 2000, Belgium

Location

AZ Sint-Jan Brugge

Bruges, 8000, Belgium

Location

Centre Hospitalier Universitaire Saint-Pierre

Brussels, 1000, Belgium

Location

Hôpital Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

CHU Charleroi Marie Curie

Charleroi, 6000, Belgium

Location

CHU Dinat Godinne

Dinant, 5500, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

UZ Brussel

Jette, 1090, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

sera or plasma samples to measure neutralizing antibodies against yellow fever

MeSH Terms

Conditions

HIV Infections

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

Study Officials

• Charlotte Martin, MD

  Centre Hospitalier Universitaire Saint Pierre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infectious Diseases Senior Resident

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 18, 2018
• Study Start: June 1, 2015
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (12)