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RecruitingAccepts healthy volunteersPhase 4

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

Louisiana State University Health Sciences Center in New Orleans · with Merck Sharp & Dohme LLC · NCT05266898

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
250
US sites recruiting
1
Study start
November 30, 2022
Record last updated
April 18, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Human papillomavirus 9-valent vaccine, recombinant; human papillomavirus vaccine, recombinant

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Recruiting US locations

  • University Medical Center New Orleans

    New Orleans, LA 70112

    Site contact: Jyotsna Fuloria · 504-702-4900 · Jyotsna.Fuloria@lcmchealth.org

Study contacts (from the official record)

  • Vice Chancellor for Academic Affairs and Research · 504-568-4804 · dporch@lsuhsc.edu
  • Executive Director, Office of Research Services · 504-568-4985 · jalam@lsuhsc.edu
All vaccine studies in Louisiana →
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV (NCT05266898) | Bored Studies