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

NCT03391921 · tracked via the Priya Life Science Belgium tracker

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Phase

Phase 4

Started

2018-01-08

Last updated

2025-02-17

Condition(s) studied

HPV - Anogenital Human Papilloma Virus InfectionHIV Infections

Investigational drug(s) / intervention(s)

Vaccine

Vaccine: 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 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.

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.

Eligibility

Sex

FEMALE

Min age

15 Years

Max age

40 Years

Healthy volunteers

Inclusion Criteria: * 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 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.

Primary outcome measure(s)

Rate of seroconversion in HPV antibodies against HPV — 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.

Trial sites (1)

Facility	City	Region	Status
Service de Maladies Infectieuses, CHU Saint-Pierre	Brussels	Belgium

More Centre Hospitalier Universitaire Saint Pierre trials in Belgium

Changes in Body Fat and Morphologic Characteristics Associated With OSA Resolution After Bariatric Surgery Recruiting

A Pilot Project for PLWH Aged 65-75: Preventing the Development of Frailty Recruiting

Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients Recruiting

Effects of Thyroidectomy on Obstructive Sleep Apnea in Patients Suffering From Goiters Recruiting

Optimizing Patient Selection for Surgery Using Pathologic Analysis Following Neoadjuvant Therapy in Locally Advanced Rectal Cancer Recruiting

Other trials for the same condition

A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy Active, not recruiting

Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women. Recruiting

Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients Active, not recruiting

A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV Active, not recruiting

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1 Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03391921 on ClinicalTrials.gov ↗ ← All trials in Belgium