HPV - Anogenital Human Papilloma Virus InfectionPhase 4PapillonNCT03391921
Vaccination Against Human Papillomavirus (HPV) With the 9-valent Vaccine in HIV-positive Women (the Papillon Study)
A Phase 4 study testing Vaccine in people with HPV - Anogenital Human Papilloma Virus Infection and HIV Infections, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial 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) in HIV-positive women aged 15-40 years with fully suppressed HIV viremia on combined antiretroviral therapy. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- HPV - Anogenital Human Papilloma Virus Infection, HIV Infections
- What is being tested?
- Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jan 2018to 2 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV-positive woman
- Age 15-40 years
- Undetectable HIV viral load (HIVRNA <400 cp/ml) for at least 6 months (i,e: having at least two separate HIVRNA <400 cp/ml at 6 months intervals; the most recent HIVRNA <400 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Service de Maladies Infectieuses, CHU Saint-Pierre
Brussels, 1000
About this study
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)
Phase IV prospective study measuring the immunogenicity (neutralizing antibody titles against each HPV vaccine genotype) of the 9-valent vaccine against HPV (Gardasil9®Merck) in HIV-positive women aged 15-40 years with fully suppressed HIV viremia on combined antiretroviral therapy.
After a first open phase evaluating tolerability of Gardasil9 (from June 2018 to December 2018), an amendment was introduced to randomize women between two different doses schedules: in the first schedule (ARM A), women will receive 2 doses at time 0 and 6 months and a third dose between 18-48 months if their antibody levels are insufficient; the second schedule (ARM B) will be 3 doses at 0, 2 and 6 months. Primary outcome is the non-inferiority of the rate of seroconversion against each HPV vaccine genotypes in women seronegative at baseline after either 2 or 3 doses of vaccination (month 7). Secondary outcomes are rate of seroconversion after 3 doses if they have received a third dose, completion of vaccine schedule, vaccine safety, antibody titles, and induction of cellular immunity against HPV contained in the vaccine, incidence of cervical HPV infection and incidence of abnormal cytology after vaccination. 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.
Read the detailed description
Number of patients:
Study: 200 patients: 50 in the first open label phase (june 2018 to dec 2018), then n=150 in the randomized phase starting in January 2019 Substudy on immune response analysis in a subset of patients: 40 patients and separated informed consent
Primary outcome:
Rate of seroconversion of neutralizing antibodies against each HPV vaccine genotypes namely 6/11/16/18/31/33/45/52/58 among women seronegative at baseline for HPV vaccine genotypes, by measuring neutralizing antibody against the 9 vaccine genotypes of HPV at baseline, month 7. The measure will be performed on a 10 ml tube by chemiluminescence immunoassay (cLIA) technique in Merck laboratory .Comparison of that rate at month 7 (non inferiority defined as at least 80% of seroconversion in ARM A).
Secondary outcomes:
- 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.
- 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/µl) will be reassessed on a second sample taken 2-4 weeks later.
- 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, 1 month after vaccination completion (month 7) and 12 months after vaccination completion (month 18). In December 2022, the protocol was amended to add follow up at month 24,36,48 and 60.
- 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.
- 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.
- 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.
- Completion of vaccine schedule. Comparison of the proportion of women achieving full course of vaccine administration in each arm, namely for ARM A receiving 2 doses and for ARM B receiving 3 doses.
- Proportion of patients needing a booster dose (i.e..a third dose) in ARM A If after 2 doses of vaccine (ARM A), the month 7 antibodies analysis shows absence of seroconversion against one of the HPV genotypes contained in the vaccine, the participant will receive a third booster dose
Number of visits:
4 to 5 mandatory visits at baseline, month 2 (not if ARM A), month 6, month 7 and month 18 plus 2 to 3 optional visits to be done in case of moderate or severe adverse reaction to vaccine administration
- Being tested
- Vaccine
- Keywords
- vaccine, woman
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccineBiological
All patients will receive the 9-valent vaccine against HPV (Gardasil9) intramuscularly: After a first open phase evaluating tolerability of Gardasil9, women will be randomized between two different doses schedules: in the first schedule, women will receive 2 doses at time 0 and 6 months and a third dose between 18-48 months if their antibody levels are insufficient; the second schedule will be 3 doses at 0, 2 and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| ARM B: 3 doses (0, 2 and 6 months) | Active comparator | ARM B: All patients will receive the 9-valent vaccine against HPV (Gardasil9) 3 doses at 0,2 and 6 months intramuscularly Receives: Biological: Vaccine |
| ARM A: 2 doses (0 and 6 months ) | Experimental | ARM A: All patients will receive the 9-valent vaccine against HPV (Gardasil9) 2 doses at 0 and 6 months intramuscularly. A third facultative dose will be given if antibodies measured at month 7 are insufficent. Receives: Biological: Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of seroconversion in HPV antibodies against HPV
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.
Measured: Month 7
Secondary outcomes (7)
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.
Measured: day 2 to 7 after each vaccine administration
Impact of vaccine administration on T-lymphocyte CD4+ cell count and HIV viremia
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.
Measured: Month 7
Measure of the geometric mean titre of specific neutralizing antibodies against each HPV vaccine genotypes (6/11/16/18/31/33/45/52/58).
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.
Measured: Month 7
Cellular immune response
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
Measured: Month 7
Incidence and prevalence rates of 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.
Measured: Month 18, 24,36,48 and 60
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 12 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.
Measured: Month 18
Completion of vaccine schedule.
Rate of patients with completion of their vaccine schedule.
Measured: Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start8 Jan 2018
- Primary completion2 May 2023
- Study completion2 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV - Anogenital Human Papilloma Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After a first open label phase evaluating tolerability of Gardasil9 in HIV-positive women and where all patients (n=50) have received three doses (0,2 and 6 months) of the 9valent vaccine against HPV from June 2018 to end of December 2018, the study will randomize participants between two between two different doses schedules: in the first schedule (ARM A), women will receive 2 doses at time 0 and 6 months and a third dose between 18-48 months if their antibody levels are insufficient; the second schedule (ARM B) will be 3 doses at 0, 2 and 6 months.
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Konopnicki, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Deborah Konopnicki, MD, PhD, Principal investigator, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391921
- Sponsor's protocol ID
- CE/17-12-06
- Acronym
- Papillon
- Status last verified
- Feb 2025
- First submitted
- 14 Dec 2017
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes
Publications
Konopnicki D, Gilles C, Manigart Y, Barlow P, Reschner A, Necsoi C, Delforge M, Vanden Broeck D, Dauby N, De Wit S. Immunogenicity and Safety of 2 Versus 3 Doses of 9-Valent Vaccine Against Human Papillomavirus in Women With Human Immunodeficiency Virus: The Papillon Randomized Trial. Clin Infect Dis. 2026 Apr 30;82(4):673-681. doi: 10.1093/cid/ciaf241.
PubMed 40356381
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03391921
- Acronym / sponsor ID
- Papillon / CE/17-12-06
- Keywords
- vaccine, woman
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2028 (estimated)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase IV prospective study measuring the immunogenicity (neutralizing antibody titles against each HPV vaccine genotype) of the 9-valent vaccine against HPV (Gardasil9®Merck) in HIV-positive women aged 15-40 years with fully suppressed HIV viremia on combined antiretroviral therapy.
After a first open phase evaluating tolerability of Gardasil9 (from June 2018 to December 2018), an amendment was introduced to randomize women between two different doses schedules: in the first schedule (ARM A), women will receive 2 doses at time 0 and 6 months and a third dose between 18-48 months if their antibody levels are insufficient; the second schedule (ARM B) will be 3 doses at 0, 2 and 6 months. Primary outcome is the non-inferiority of the rate of seroconversion against each HPV vaccine genotypes in women seronegative at baseline after either 2 or 3 doses of vaccination (month 7). Secondary outcomes are rate of seroconversion after 3 doses if they have received a third dose, completion of vaccine schedule, vaccine safety, antibody titles, and induction of cellular immunity against HPV contained in the vaccine, incidence of cervical HPV infection and incidence of abnormal cytology after vaccination. 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 description
Number of patients:
Study: 200 patients: 50 in the first open label phase (june 2018 to dec 2018), then n=150 in the randomized phase starting in January 2019 Substudy on immune response analysis in a subset of patients: 40 patients and separated informed consent
Primary outcome:
Rate of seroconversion of neutralizing antibodies against each HPV vaccine genotypes namely 6/11/16/18/31/33/45/52/58 among women seronegative at baseline for HPV vaccine genotypes, by measuring neutralizing antibody against the 9 vaccine genotypes of HPV at baseline, month 7. The measure will be performed on a 10 ml tube by chemiluminescence immunoassay (cLIA) technique in Merck laboratory .Comparison of that rate at month 7 (non inferiority defined as at least 80% of seroconversion in ARM A).
Secondary outcomes:
- 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.
- 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/µl) will be reassessed on a second sample taken 2-4 weeks later.
- 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, 1 month after vaccination completion (month 7) and 12 months after vaccination completion (month 18). In December 2022, the protocol was amended to add follow up at month 24,36,48 and 60.
- 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.
- 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.
- 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.
- Completion of vaccine schedule. Comparison of the proportion of women achieving full course of vaccine administration in each arm, namely for ARM A receiving 2 doses and for ARM B receiving 3 doses.
- Proportion of patients needing a booster dose (i.e..a third dose) in ARM A If after 2 doses of vaccine (ARM A), the month 7 antibodies analysis shows absence of seroconversion against one of the HPV genotypes contained in the vaccine, the participant will receive a third booster dose
Number of visits:
4 to 5 mandatory visits at baseline, month 2 (not if ARM A), month 6, month 7 and month 18 plus 2 to 3 optional visits to be done in case of moderate or severe adverse reaction to vaccine administration
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After a first open label phase evaluating tolerability of Gardasil9 in HIV-positive women and where all patients (n=50) have received three doses (0,2 and 6 months) of the 9valent vaccine against HPV from June 2018 to end of December 2018, the study will randomize participants between two between two different doses schedules: in the first schedule (ARM A), women will receive 2 doses at time 0 and 6 months and a third dose between 18-48 months if their antibody levels are insufficient; the second schedule (ARM B) will be 3 doses at 0, 2 and 6 months.
| Arm | Type | Receives |
|---|---|---|
| ARM B: 3 doses (0, 2 and 6 months) | Active comparator | Biological: VaccineARM B: All patients will receive the 9-valent vaccine against HPV (Gardasil9) 3 doses at 0,2 and 6 months intramuscularly |
| ARM A: 2 doses (0 and 6 months ) | Experimental | Biological: VaccineARM A: All patients will receive the 9-valent vaccine against HPV (Gardasil9) 2 doses at 0 and 6 months intramuscularly. A third facultative dose will be given if antibodies measured at month 7 are insufficent. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- HIV-positive woman
- Age 15-40 years
- Undetectable HIV viral load (HIVRNA <400 cp/ml) for at least 6 months (i,e: having at least two separate HIVRNA <400 cp/ml at 6 months intervals; the most recent HIVRNA <400 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaccineAll patients will receive the 9-valent vaccine against HPV (Gardasil9) intramuscularly: After a first open phase evaluating tolerability of Gardasil9, women will be randomized between two different doses schedules: in the first schedule, women will receive 2 doses at time 0 and 6 months and a third dose between 18-48 months if their antibody levels are insufficient; the second schedule will be 3 doses at 0, 2 and 6 months. | Biological | ARM A: 2 doses (0 and 6 months ), ARM B: 3 doses (0, 2 and 6 months) |
Primary outcome
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.
7 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability of the vaccines).
Time frame: day 2 to 7 after each vaccine administration
Impact of vaccine administration on T-lymphocyte CD4+ cell count and HIV viremia
Time frame: Month 7
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
Cellular immune response
Time frame: Month 7
Incidence and prevalence rates of HPV infections
Time frame: Month 18, 24,36,48 and 60
The incidence and prevalence rates of abnormal cervical cytology
Time frame: Month 18
Completion of vaccine schedule.
Time frame: Month 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 40356381Konopnicki D, Gilles C, Manigart Y, Barlow P, Reschner A, Necsoi C, Delforge M, Vanden Broeck D, Dauby N, De Wit S. Immunogenicity and Safety of 2 Versus 3 Doses of 9-Valent Vaccine Against Human Papillomavirus in Women With Human Immunodeficiency Virus: The Papillon Randomized Trial. Clin Infect Dis. 2026 Apr 30;82(4):673-681. doi: 10.1093/cid/ciaf241.
- Individual participant dataSharing planned: Yes. Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Konopnicki, MD, PhD principal investigator
Centre Hospitalier Universitaire Saint Pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaccine in people with HPV - Anogenital Human Papilloma Virus Infection and HIV Infections, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of seroconversion in HPV antibodies against HPV (time frame: Month 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03391921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.