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

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ClinicalTrials.gov Identifier: NCT03591003
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Charlotte Martin, Centre Hospitalier Universitaire Saint Pierre

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:

  1. To identify risk factors for early and late waning of NT after YF immunization
  2. To modelize kinetics of NT after YF immunization in different subpopulations of HIV patients, including population of young HIV patients infected vertically
  3. To identify risk factors for absence of seroconversion in the year after YF immunization
  4. To compare persistence of NT in HIV patients infected vertically or not vertically
  5. To quantify seroconversion rate after YF vaccination Methodology / study design This study is a single arm, non randomized, cross-sectional, multicenter study in AIDS Reference Centers from Belgium.

The maximum duration of the study for each patient will be 1 visit, consisting of:

  • 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

  1. Number of patients with protective YF NT ≥ 1:10 in the year following YF immunization
  2. Risk factors (demographics and immunovirological parameters, antiretroviral treatment) for absence of seroconversion in the year following YF immunization
  3. Risk factors (demographics and immunovirological parameters, antiretroviral treatment) of early waning (before 10 years) of YF NT
  4. Risk factors (demographics and immunovirological parameters, antiretroviral treatment) of late waning (after 10 years) of YF NT Eligibility Inclusion criteria

1. Infection with HIV-1 (vertical transmission or not) 2. Immunization with at least one injection of YF vaccine (Stamaril®,17D strain Rockefeller, Sanofi Pasteur) with proof of vaccine administration 3. Informed consent signed prior to any study procedure Exclusion criteria Inability to give informed consent

Substudies

  • 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

Condition or disease Intervention/treatment
HIV Infections Yellow Fever Vaccine Diagnostic Test: Yellow fever neutralizing antibodies measure

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: "Persistence of Neutralizing Antibodies After Immunization Against Yellow Fever (YF) in HIV-infected Patients: a Multicenter Study"
Actual Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Group/Cohort Intervention/treatment
HIV-infected patients
HIV-infected patients vaccinated at least once in their life against yellow fever
Diagnostic Test: Yellow fever neutralizing antibodies measure
Yellow fever neutralizing antibodies measure before vaccination, within the year after vaccination and at any delay after vaccination




Primary Outcome Measures :
  1. Number of HIV patients with protective YF NT ≥ 1:10 at different timepoints after YF immunization [ Time Frame: up to 60 years after YF vaccine administration ]
    protective YF NT ≥ 1:10


Secondary Outcome Measures :
  1. Number of patients with protective YF NT ≥ 1:10 in the year following YF immunization [ Time Frame: up to 1 year after YF immunization ]
    protective YF NT ≥ 1:10

  2. Risk factors for absence of seroconversion in the year following YF immunization [ Time Frame: up to 1 year after YF immunization ]
    Risk factors (demographics and immunovirological parameters, antiretroviral treatment, number of yellow fever vaccines)

  3. Risk factors of early waning (before 10 years) of YF NT [ Time Frame: before 10 years after YF immunization ]
    Risk factors (demographics and immunovirological parameters, antiretroviral treatment, number of YF vaccines)

  4. Risk factors of late waning (after 10 years) of YF NT [ Time Frame: after 10 years up to 60 years after YF vaccine administration ]
    Risk factors (demographics and immunovirological parameters, antiretroviral treatment, number of yellow fever vaccines)


Biospecimen Retention:   Samples Without DNA
sera or plasma samples to measure neutralizing antibodies against yellow fever


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • 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 )

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591003


Contacts
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Contact: Charlotte Martin, MD 003225354130 charlotte_martin@stpierre-bru.be
Contact: Stéphane De Wit, PhD 003225354130 infectiousdiseases@stpierre-bru.be

Locations
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Belgium
Instituut voor Tropische Geneeskunde Recruiting
Antwerp, Belgium, 2000
Contact: Eric Florence, MD    00 32 3 247 66 42    eflorence@itg.be   
AZ Sint-Jan Brugge Recruiting
Brugge, Belgium, 8000
Contact: Jens Van Praet, MD    0032 50 45 22 01    Jens.VanPraet@azsintjan.be   
Centre Hospitalier Universitaire Saint-Pierre Recruiting
Brussels, Belgium, 1000
Contact: Coca Necsoi, MD    003225354130    infectiousdiseases@stpierre-bru.be   
Hôpital Erasme Recruiting
Brussels, Belgium, 1070
Contact: Jean-Christophe Goffard, PhD    0032 2 555 45 36    jc.goffard@erasme.ulb.ac.be   
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Leila Belkhir, PhD    0032 2 764 11 11    leila.belkhir@uclouvain.be   
CHU Charleroi Marie Curie Recruiting
Charleroi, Belgium, 6000
Contact: Samuel Markowicz, MD    00 32 71 92 13 11    samuel.markowicz@chu-charleroi.be   
CHU Dinat Godinne Recruiting
Dinant, Belgium, 5500
Contact: Nathalie Ausselet, MD    00 32 81 42 20 81    nathalie.ausselet@uclouvain.be   
UZ Gent Recruiting
Gent, Belgium, 9000
Contact: Linos Vandekerkhove, PhD    00 32 9 332 23 45    Linos.Vandekerckhove@UGent.be   
Jessa Ziekenhuis Recruiting
Hasselt, Belgium, 3500
Contact: Peter Messiaen, PhD    00 32 11 30 84 85    peter.messiaen@jessazh.be   
UZ Brussel Recruiting
Jette, Belgium, 1090
Contact: Patrick Lacor    00 32 477 60 01    Patrick.Lacor@uzbrussel.be   
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Inge Derdelinckx, PhD    00 32 16 34 42 75    inge.derdelinckx@uzleuven.be   
Centre Hospitalier Universitaire de Liège Recruiting
Liège, Belgium, 4000
Contact: Philippe Leonard, MD    00 32 4 242 52 00    philippe.leonard@chu.ulg.ac.be   
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
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Principal Investigator: Charlotte Martin, MD Centre Hospitalier Universitaire Saint Pierre

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Responsible Party: Charlotte Martin, Infectious Diseases Senior Resident, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT03591003     History of Changes
Other Study ID Numbers: B076201421922
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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HIV Infections
Fever
Yellow Fever
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
Hemorrhagic Fevers, Viral
Antibodies
Immunoglobulins
Antibodies, Blocking
Immunologic Factors
Physiological Effects of Drugs