Clinical trial · Interventional
An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men
- 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)
This study was conducted to demonstrate that Gardasil™ (quadrivalent human papillomavirus \[qHPV\] vaccine) 1) is well tolerated in young men, 2) reduces incidence of external genital lesions in young men, 3) reduces the incidence of anal intraepithelial neoplasia (AIN) or anal cancer in men having sex with men (MSM), and 4) reduces incidence of Human Papillomavirus (HPV) infection in young men. In the 7-month Base Study participants received randomly assigned qHPV vaccine or placebo at Day 1, Month 2, and Month 6. Base Study follow-up continued through Month 36. In Extension 1 (EXT1), participants who received placebo or an incomplete qHPV vaccine regimen in the Base Study were offered qHPV vaccine. Participants were followed in EXT1 for 7 months. In Extension 2 \[LTFU (EXT2)\], long-term effectiveness, immunogenicity, and safety of qHPV vaccine were followed up to 10 years following study enrollment. Participants who received ≥1 dose of qHPV vaccine in the Base Study or EXT1 were eligible to enroll in LTFU (EXT2).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Condylomata Acuminata | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: placebo (unspecified) | Biological | — | UNRESOLVED |
| (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- qHPV Vaccine
- description
- The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36.
- interventionNames
- Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36.
- interventionNames
- Biological: Comparator: placebo (unspecified)
Primary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 16 Years
- Maximum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy heterosexual males between the ages of 16 years and 23 years and 364 days. Healthy men having sex with men (MSM) between the ages of 16 years and 26 years and 364 days. * No clinical evidence of genital lesions suggesting sexually-transmitted disease, and no history of anogenital warts * Additional criteria will be discussed with you by the physician Exclusion Criteria: * Concurrently enrolled in a clinical study involving collection of genital specimens * History of known prior vaccination with an HPV vaccine * Received an inactivated vaccine within 14 days or a live virus vaccine within 21 days prior to enrollment * History of a severe allergic reaction that required medical intervention * Received any immune globulin or blood-derived products within 6 months prior to the first study injection * History of splenectomy, immune disorders, or receiving immunosuppressives * Immunocompromised or diagnosed with HIV infection * Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections * History of recent or ongoing alcohol or drug abuse
References
Publications (10)
- DERIVEDBroshkevitch CJ, Giuliano AR, Palefsky JM, Nahhas G, Goldstone SE, Dubin B, Saah A, Luxembourg A, Velicer C, Tota JE. Assessment of Concordant Human Papillomavirus Infection With 9-Valent Vaccine Types Across Anogenital Sites in Young Men. J Infect Dis. 2026 Feb 18;233(2):e462-e470. doi: 10.1093/infdis/jiaf564. PMID 41400842
- DERIVEDBergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. PMID 41276263
- DERIVEDPalefsky JM, Giuliano AR, Goldstone SE, Dubin B, Saah A, Luxembourg A, Velicer C, Tota JE. Anal Human Papillomavirus Infection Progression to Disease Among Men Who Have Sex With Men. Clin Infect Dis. 2026 Mar 17;82(3):e616-e625. doi: 10.1093/cid/ciaf584. PMID 41162330
- DERIVEDGiuliano AR, Palefsky JM, Goldstone SE, Dubin B, Saah A, Luxembourg A, Velicer C, Tota JE. High Risk of New HPV Infection Acquisition Among Unvaccinated Young Men. J Infect Dis. 2024 Mar 14;229(3):707-718. doi: 10.1093/infdis/jiad485. PMID 38012959
- DERIVEDGoldstone SE, Giuliano AR, Palefsky JM, Lazcano-Ponce E, Penny ME, Cabello RE, Moreira ED Jr, Baraldi E, Jessen H, Ferenczy A, Kurman R, Ronnett BM, Stoler MH, Bautista O, Das R, Group T, Luxembourg A, Zhou HJ, Saah A. Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2022 Mar;22(3):413-425. doi: 10.1016/S1473-3099(21)00327-3. Epub 2021 Nov 12. PMID 34780705
- DERIVEDTota JE, Giuliano AR, Goldstone SE, Dubin B, Saah A, Luxembourg A, Velicer C, Palefsky JM. Anogenital Human Papillomavirus (HPV) Infection, Seroprevalence, and Risk Factors for HPV Seropositivity Among Sexually Active Men Enrolled in a Global HPV Vaccine Trial. Clin Infect Dis. 2022 Apr 9;74(7):1247-1256. doi: 10.1093/cid/ciab603.