Clinical trial · Interventional
Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV
NCT04255849CI-TRIAL-00115316active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
This is a randomized, double-blinded, placebo-controlled Phase III interventional trial of the nine-valent HPV vaccine (9vHPV) to prevent persistent oral HPV infection in adult men living with HIV.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV-1-infection | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
| HPV Positive Oropharyngeal Squamous Cell Carcinoma | Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 9 valent human papillomavirus vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) | Biological | — | UNRESOLVED |
| Saline Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 9-valent HPV vaccine
- description
- Participants receive 9-valent HPV vaccine 0.5mL at entry, Month 2 and Month 6
- interventionNames
- Biological: 9 valent human papillomavirus vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)
- type
- PLACEBO_COMPARATOR
- label
- Saline Placebo
- description
- Participants receive 0.9% NaCl 0.5 mL at entry, Month 2 and Month 6
- interventionNames
- Other: Saline Placebo
Primary outcomes (1)
- measure
- Number of participants with new persistent oral HPV infections with one or more of the following types: 6, 11, 16, 18, 31, 33, 45, 52, or 58
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * HIV-1 infection * Receipt of antiretroviral therapy for at least 6 months * Sexually active in the past 6 months; sexual activity is defined as insertive penile-vaginal sex, receptive or insertive penile-anal sex, oral-anal sex, or oral-genital sex Willingness to comply with three-dose vaccine schedule and subsequent six-month visits for up to four years after randomization. Exclusion Criteria: * Have a history of oropharyngeal cancer (OPC) or other HPV-related cancer or have suspected OPC or other HPV-related cancer; * Have received any doses of a licensed or experimental HPV vaccine or have participated in an HPV vaccine study, * Have a history of anaphylaxis to vaccines or are allergic to any vaccine component (e.g.aluminum, yeast, benzonase); * Have received any blood products within six months of enrollment, or are currently taking immune-suppressants. * Currently have warts/lesions in the oral cavity. * Plan to relocate during the study period. * Have AIDS-defining condition within 6 months prior to study entry.
References
Publications (1)
- DERIVEDGiuliano AR, Beltrame A, Villa LL, Lazcano-Ponce E, Santana-Bagur J, Allen-Leigh B, Portillo-Romero AJ, Sahasrabuddhe VV, House MG, Brofsky E, Galan de Paula L, Carvalho da Silva R, Schell MJ, Rathwell J, Isaacs-Soriano K, Fan W, Mello C, Ellsworth GB, Wilkin T. Design of a multicenter, randomized, double-blinded, placebo-controlled phase III trial evaluating the 9-valent human papillomavirus (HPV) vaccine to prevent persistent oral HPV infection in men living with human immunodeficiency virus: ULACNet trial 201. Vaccine. 2025 Aug 13;61:127447. doi: 10.1016/j.vaccine.2025.127447. Epub 2025 Jul 2. PMID 40609265