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New treatment option for Papillomavirus Vaccines
Official title Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
ClinicalTrials.gov ID: NCT05266898
What this study is testing
What is Human papillomavirus 9-valent vaccine, recombinant?
Human papillomavirus 9-valent vaccine, recombinant is an investigational medicine, being studied as a potential treatment for papillomavirus vaccines.
Also referred to as Gardasil-9, Nonavalent HPV vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Orleans, Louisiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Orleans, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.