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

NCT03391921 | Active Not Recruiting Phase 4

• 1 other identifier: CE/17-12-06
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

HPV - Anogenital Human Papilloma Virus Infection; HIV Infections

Keywords

vaccine; woman

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 7

Secondary Outcomes (7)

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

  day 2 to 7 after each vaccine administration

• Impact of vaccine administration on T-lymphocyte CD4+ cell count and HIV viremia

  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).

  Month 7

• Cellular immune response

  Month 7

• Incidence and prevalence rates of HPV infections

  Month 18, 24,36,48 and 60

Study Arms (2)

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

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.

Biological: Vaccine

Interventions

Vaccine BIOLOGICAL

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.

ARM A: 2 doses (0 and 6 months ); ARM B: 3 doses (0, 2 and 6 months)

Eligibility Criteria

• Age: 15 Years - 40 Years
• Gender Eligibility Details: only female will be included
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

Service de Maladies Infectieuses, CHU Saint-Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Deborah Konopnicki, MD, PhD

  Centre Hospitalier Universitaire Saint Pierre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic, Infectious Diseases Department

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 5, 2018
• Study Start: January 8, 2018
• Primary Completion: May 2, 2023
• Study Completion (Estimated): May 2, 2028
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: within 12 months of the study completion

Locations

BE (1)