Last updated on February 2019

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


Brief description of study

Phase IV prospective study measuring the immunogenicity (neutralizing antibody titles against each HPV vaccine genotype) of the 9-valent vaccine against HPV (Gardasil9Merck, 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.

Detailed Study Description

Number of patients:

Study: 200 patients Substudy on immune response analysis in a subset of patients: 40 patients and separated informed consent

Primary outcome:

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. The measure will be performed on a 10 ml tube by chemiluminescence immunoassay (cLIA) technique in Merck laboratory .

Secondary outcomes:

  1. Incidence of Treatment-Emergent Adverse Events (Safety and tolerability of the vaccines).

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. The potential impact of vaccine administration on T-lymphocyte-CD4+ cell count and HIV viremia It 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/l) 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).

It will be assessed before vaccination and 1 month after vaccination completion.

4. The cellular immune response The cellular immune response ill be evaluated in a subset of 40 patients (aged 18-40 years old) by measuring specific T-lymphocytes-CD4+ cells expressing CD40-receptor, interleukin-2 (IL2), interferon gamma (IFN-g) or Tumor necrosis factor (TNF-alpha ) against HPV 16/18/31/52 and 58. The analysis will be performed on a peripheral blood mononuclear cell (PBMC) sample of 30 to 50 ml taken at baseline and at month 7; a separate informed consent (IC) has to be signed for this sub-analysis.

5. The incidence and prevalence rates of cervical HPV infections:

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:

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. The rate of patients who could complete their full vaccine schedule will be calculated at month 7.

Number of visits:

5 mandatory visits at baseline, month 2, month 6, month 7 and month 18 plus 3 optional visits to be done in case of moderate or severe adverse reaction to vaccine administration

Clinical Study Identifier: NCT03391921

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Recruitment Status: Open


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