Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV

NCT05266898 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 2070MISP61476
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine the magnitude and breadth of the serum antibody response to the nonavalent HPV vaccine (Gardasil-9) in adults with well-controlled HIV infection. The secondary objectives of the study are to observe short term clinical outcomes of prevalent HPV genotype-specific anogenital infections in adults living with HIV who complete the three-dose Gardasil-9 vaccine series, and to determine the protection afforded by Gardasil vaccine over time in previously vaccinated adults living with HIV. The clinical hypothesis is that adults with virologically controlled HIV mount a serum antibody response to the nonavalent HPV vaccine that is comparable to HIV negative counterparts. We also postulate that HPV vaccination will provide short-term clinical benefit against HPV infections and disease associated with vaccine genotypes and continuing protection against vaccine genotypes of HPV over time.

Conditions

Papillomavirus Vaccines; Human Immunodeficiency Virus; Papillomavirus Infection; Serology; Cervical Intraepithelial Neoplasia; Anal Intraepithelial Neoplasia; Oral Cavity Infection

Keywords

Gardasil-9 HPV vaccine; human papillomavirus; human immunodeficiency virus

Outcome Measures

Primary Outcomes (2)

• change in serological response to Gardasil-9

  serum antibodies against human papillomavirus genotypes 6,11,16,18,31,33,45,52, and 58

  18 months

• serum antibody titers in vaccine-experienced cohort

  serum antibody titers against Gardasil-9 vaccine HPV genotypes in cohort of individuals with prior vaccine history, compared to time-since-vaccine completion

  Variable time-since-vaccine completion. Single time-point evaluation.

Secondary Outcomes (3)

• change in HPV infection status: resolution of prevalent HPV infection

  18 months

• change in HPV infection status: protection against incident HPV infection

  18 months

• HPV prevalence in vaccine experienced cohort

  Variable time since vaccine series completion. Single time-point evaluation.

Other Outcomes (1)

• change in mucosal antibody response to Gardasil-9

  18 months

Study Arms (2)

Gardasil-9 recipients

EXPERIMENTAL

Participants receive 3-dose Gardasil-9 vaccine series.

Biological: Human papillomavirus 9-valent vaccine, recombinant

Gardasil vaccine experienced cohort

OTHER

Observational cohort to determine Gardasil HPV serum antibody titers in relation to time since vaccine series completion.

Biological: human papillomavirus vaccine, recombinant

Interventions

Human papillomavirus 9-valent vaccine, recombinant BIOLOGICAL

Subunit vaccine against 9 genotypes of human papillomavirus (6, 11, 16, 18, 31, 33, 45, 52, 58)

Also known as: Gardasil-9, Nonavalent HPV vaccine

Gardasil-9 recipients

human papillomavirus vaccine, recombinant BIOLOGICAL

Subunit vaccine against four (6, 11, 16, 18) or nine (6, 11, 16, 18, 31, 33, 45, 52, 58) genotypes of human papillomavirus. Administered as part of participant's clinical care prior to study enrollment (intervention not delivered as part of study design).

Also known as: Gardasil-4, Quadrivalent HPV vaccine, Gardasil-9, Nonavalent HPV vaccine

Gardasil vaccine experienced cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV seropositive
• immune intact (CD4+ T cell count in peripheral blood \>200 cells/ml)
• HIV controlled (peripheral blood HIV viral load \<1,000 genome copies/mL)
• Stable on antiretroviral regimen for ≥3 months
• Gardasil-9 naive and age ≤45 OR
• documented receipt of 3 doses of Gardasil-4 or Gardasil-9 HPV vaccine

You may not qualify if:

• Medical contraindication for vaccination (vaccine-naive arm only)
• Women who are pregnant
• Acute illness
• Taking chronic steroids, \>0.5mg/kg prednisone or equivalent
• Taking immune modulating medications
• Received blood transfusion/blood products within the past 6 months
• Recipients of other vaccine products within the past month
• Inability to provide informed written consent

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Related Publications (1)

• Hagensee ME, Yaegashi N, Galloway DA. Self-assembly of human papillomavirus type 1 capsids by expression of the L1 protein alone or by coexpression of the L1 and L2 capsid proteins. J Virol. 1993 Jan;67(1):315-22. doi: 10.1128/JVI.67.1.315-322.1993.

  PMID: 8380079 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Papillomavirus Infections; Uterine Cervical Dysplasia

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent; Papillomavirus Vaccines; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Jennifer E Cameron, PhD

  Louisiana State University Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Michael E Hagensee, MD, PhD

  Louisiana State University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vice Chancellor for Academic Affairs and Research

CONTACT

504-568-4804; dporch@lsuhsc.edu

Executive Director, Office of Research Services

CONTACT

504-568-4985; jalam@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-arm trial of serological response to Gardasil-9 HPV vaccine in immunocompetent adults (age 18-45) with HIV infection. All study participants will receive Gardasil-9 3-dose series, or will have confirmed prior experience with all three doses of Gardasil vaccine (quadrivalent or nonavalent).

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: November 30, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)