Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Intraepithelial Neoplasia | Anal Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
| Oral Cavity Infection | — | UNRESOLVED | — |
| Papillomavirus Infection | — | UNRESOLVED | — |
| Papillomavirus Vaccines | — | UNRESOLVED | — |
| Serology | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Human papillomavirus 9-valent vaccine, recombinant | Biological | — | UNRESOLVED |
| human papillomavirus vaccine, recombinant | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gardasil-9 recipients
- description
- Participants receive 3-dose Gardasil-9 vaccine series.
- interventionNames
- Biological: Human papillomavirus 9-valent vaccine, recombinant
- type
- OTHER
- label
- Gardasil vaccine experienced cohort
- description
- Observational cohort to determine Gardasil HPV serum antibody titers in relation to time since vaccine series completion.
- interventionNames
- Biological: human papillomavirus vaccine, recombinant
Primary outcomes (2)
- measure
- change in serological response to Gardasil-9
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDHagensee 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