RecruitingPhase 4NCT05266898

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

Prospective Observational Immunogenicity Trial of Gardasil-9 HPV Vaccine in People Living With Adequately Managed HIV

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Enrollment

250 participants

Start Date

Nov 30, 2022

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the Gardasil-9 HPV vaccine (which protects against cervical and other cancers caused by human papillomavirus) works effectively in people living with HIV who have well-controlled disease. Since HIV can weaken the immune system, researchers want to confirm that HIV-positive individuals can still build strong immunity to HPV through vaccination. **You may be eligible if...** - You are HIV-positive - Your immune system is relatively intact (CD4+ count above 200 cells/ml) - Your HIV viral load is well controlled (below 1,000 copies/ml) - You have been on a stable anti-HIV regimen for at least 3 months - You have never received the Gardasil-9 vaccine and are 45 or younger, OR you completed 3 doses of Gardasil-4 or Gardasil-9 previously **You may NOT be eligible if...** - You have a medical reason you cannot receive vaccines - You are pregnant - You have an acute illness or are taking high-dose steroids or immune-modifying medications - You received another vaccine in the past month or a blood transfusion in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHuman papillomavirus 9-valent vaccine, recombinant

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

BIOLOGICALhuman papillomavirus vaccine, recombinant

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).