Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
Recruiting
Phase 4
Interventional Study
Papillomavirus Vaccines
Human Immunodeficiency Virus
Papillomavirus Infection
Serology
Cervical Intraepithelial Neoplasia
Anal Intraepithelial Neoplasia
Oral Cavity Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 250 (estimated)
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans · Other
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About This Trial
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…
Trial Locations
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Eligibility 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 dose…
Contacts