ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 7102 for:    vaccination

Vaccination Against Human Papillomavirus (HPV) With the 9-valent Vaccine in HIV-positive Women (the Papillon Study) (Papillon)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03391921
Recruitment Status : Not yet recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Deborah Konopnicki, Centre Hospitalier Universitaire Saint Pierre

Brief Summary:
Phase IV prospective study measuring the immunogenicity (neutralizing antibody titles against each HPV vaccine genotype) of the 9-valent vaccine against HPV (Gardasil9®Merck, three doses at 0, 2 and 6 months) in HIV-positive women aged 15-40 years with fully suppressed HIV viremia on combined antiretroviral therapy. The safety of the vaccination (local or systemic reaction and impact on HIV viral control and immunodeficiency level) will be assessed. The cellular immune response will be assessed in a subgroup of patients.

Condition or disease Intervention/treatment Phase
HPV - Anogenital Human Papilloma Virus Infection Hiv Biological: Vaccine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All patients will receive the ninevalent vaccine against HPV (Garadsil9)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Longitudinal Study on Immunogenicity, Induction of Cellular Immune Responses and Safety of Vaccination Against HPV With the 9-valent Vaccine in HIV-positive Women (The Papillon Study)
Estimated Study Start Date : January 8, 2018
Estimated Primary Completion Date : January 8, 2020
Estimated Study Completion Date : January 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Vaccine
All patients will receive the 9-valent vaccine against HPV (Gardasil9) 3 doses at 0,2 and 6 months intramuscularly
Biological: Vaccine
All patients will receive the 9-valent vaccine against HPV (Gardasil9) 3 doses at 0,2 and 6 months intramuscularly




Primary Outcome Measures :
  1. Rate of seroconversion in HPV antibodies against HPV [ Time Frame: Month 7 ]
    The rate of seroconversion of specific neutralizing antibodies against each HPV vaccine genotypes (6/11/16/18/31/33/45/52/58) one month after completion of a three doses schedule (0, 2 and 6 months) in women seronegative at baseline for these antibodies.


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Safety and tolerability of the vaccines). [ Time Frame: day 2 to 7 after each vaccine administration ]
    It will be evaluated by a specific questionnaire on a phone call made by the research team to the participant and scheduled at least 48 hours and maximum 7 days after each vaccine dose; the questionnaire will evaluate whether there is any complain regarding local reaction (pain, redness, swelling, pruritus), systemic reaction (fever, malaise and fatigue) or other side effect. In case of any usual complain > mild stage, or the presence of an unusual complain, the patient will be assessed by a visit and physical examination performed by the research team. The questionnaire has been elaborated according to the published data on safety evaluation of the 9-valent vaccine.

  2. Impact of vaccine administration on T-lymphocyte CD4+ cell count and HIV viremia [ Time Frame: Month 7 ]
    The potential impact of vaccine administration on T-lymphocyte CD4+ cell count and HIV viremia will be assessed by measuring CD4 cell count and HIV viremia at baseline (any measure within 6 months before screening can be taken into account) and month 7. Any detectable HIVRNA >50 cp/ml will be reassessed on a second samples taken 2-4 weeks later. Any significant decrease in T-lymphocyte CD4+ cell count (defined as a decrease by more of 5% in the percentage or >100 cells/µl) will be reassessed on a second sample taken 2-4 weeks later.

  3. Measure of the geometric mean titre of specific neutralizing antibodies against each HPV vaccine genotypes (6/11/16/18/31/33/45/52/58). [ Time Frame: Month 7 ]
    The measure of the geometric mean titre of specific neutralizing antibodies against each HPV vaccine genotypes (6/11/16/18/31/33/45/52/58) will be assessed before vaccination and 1 month after vaccination completion.

  4. Cellular immune response [ Time Frame: Month 7 ]
    The cellular immune response will be evaluated in a subset of 40 patients (aged 18-40 years old) by measuring specific CD4+T cells expressing CD40, IL2, IFN-g or TNF-alpha against HPV 16/18/31/52 and 58. The analysis will be performed on a PMBC sample; a separate IC has to be signed for this sub-analysis

  5. Incidence and prevalence rates of HPV infections [ Time Frame: Month 18 ]
    Detection of HPV will be performed by molecular technique by the national reference center for HPV (AML, Antwerpen), performed on cervical swab taken by the gynecologist at baseline and month 18. The baseline gynecological sample might have been taken up to 6 months before the vaccination. These swabs will be sampled in all participants with previous vaginal sexually activity. In case of no previous vaginal sexual intercourse, the samples will not be taken.

  6. The incidence and prevalence rates of abnormal cervical cytology [ Time Frame: Month 18 ]
    Cervical cytology will be performed by by the national reference center for HPV (AML, Antwerpen) on cervical swab taken by the gynecologist at baseline and month 18. The baseline gynecological sample might have been taken up to 6 months before the vaccination. These swabs will be sampled in all participants with previous vaginal sexually activity. In case of no previous vaginal sexual intercourse, the samples will not be taken.

  7. Completion of vaccine schedule. [ Time Frame: Month 7 ]
    Rate of patients with completion of their vaccine schedule.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only female will be included
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-positive woman
  • Age 15-40 years
  • Undetectable HIV viral load (HIVRNA <50 cp/ml) for at least 6 months (i,e: having at least two separate HIVRNA <50 cp/ml at 6 months intervals; the most recent HIVRNA <50 cp/ml may be performed with the baseline sample for the study).
  • No planned pregnancy foreseen for the next 7 months and use of contraception such as condom, hormonal contraception or intrauterine device
  • IC signed

Exclusion Criteria:

  • Previous hysterectomy or conisation
  • Previous or current biopsy-proven cervical, vulvar or vaginal HPV-associated lesion defined as ≥ cervical intraepithelial neoplasia grade 2(CIN2) ) , Vulvar intraepithelial neoplasia grade 2 (VIN2), vaginal intraepithelial neoplasia grade 2 (VaIN2 ) or invasive carcinoma
  • Previous vaccination against HPV (at least one dose)
  • Ongoing or planned pregnancy foreseen in the next 7 months
  • Other immunodeficiency conditions such as ongoing or previous (within 6 months) chemotherapy against cancer or chronic systemic corticosteroids treatment or immunosuppressive therapy after transplantation
  • Any condition contraindicating intramuscular injection such as warfarin therapy.

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): NCT03391921


Contacts
Contact: Deborah Konopnicki, MD, PhD +3225354130 deborah_konopnicki@stpierre-bru.be
Contact: Stephane De Wit, MD, PhD +3225354130 stephane_dewit@stpierre.be

Locations
Belgium
Service de Maladies Infectieuses, CHU Saint-Pierre Recruiting
Brussels, Belgium, 1000
Contact: Deborah Konopnicki, MD,PhD    +3225354130    deborah_konopnicki@stpierre-bru.be   
Contact: Stephane De Wit, MD, PhD    +3225354130    stephane_dewit@stpierre-bru.be   
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
Principal Investigator: Deborah Konopnicki, MD, PhD Centre Hospitalier Universitaire Saint Pierre

Responsible Party: Deborah Konopnicki, Head of clinic, Infectious Diseases Department, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT03391921     History of Changes
Other Study ID Numbers: CE/17-12-06
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Deborah Konopnicki, Centre Hospitalier Universitaire Saint Pierre:
vaccine
woman

Additional relevant MeSH terms:
Vaccines
Virus Diseases
Papilloma
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
DNA Virus Infections
Tumor Virus Infections
Immunologic Factors
Physiological Effects of Drugs