Phase 3
N=4,065
An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
Condylomata Acuminata
Bottom Line
View on ClinicalTrials.gov: NCT00090285 ↗Enrolled (actual)
4,065
Serious AEs
0.4%
Results posted
Nov 2009
Primary outcome: Primary: Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer — 0.1; 1.0 Incidence per 100 person-years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Biological); Comparator: placebo (unspecified) (Biological)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Male
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer |
0.1; 1.0 | — |
| PRIMARY Overall Study: Incidence of HPV Type 6/11-related Genital Warts |
4.3 | — |
| PRIMARY Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer |
3.8 | — |
| PRIMARY Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer |
69.3 | — |
| PRIMARY Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs) |
25; 20 | — |
| PRIMARY Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) |
0; 0 | — |
| PRIMARY LTFU (EXT2): Number of Participants With Vaccine-Related SAEs |
0; 0 | — |
| PRIMARY LTFU (EXT2): Number of Participants Who Died |
5; 2 | — |
| SECONDARY Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection |
0.7; 4.8 | — |
| SECONDARY Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection |
5.3; 10.7 | — |
| SECONDARY Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA) |
447.7; 624.4; 2406.1; 402.8 | — |
| SECONDARY Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA |
71.5; 82.5; 293.6; 33.2 | — |
| SECONDARY Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA |
57.2; 62.1; 249.4; 25.9 | — |
| SECONDARY Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA |
49.4; 38.7; 182.9; 17.6 | — |
| SECONDARY Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA |
98.9; 99.2; 98.8; 97.4 | — |
| SECONDARY Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA |
88.9; 94.0; 97.9; 57.1 | — |
| SECONDARY Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA |
84.3; 88.0; 97.0; 49.6 | — |
| SECONDARY Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA |
79.1; 79.9; 94.9; 40.2 | — |
| SECONDARY Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) |
38.8; 31.0; 162.0; 19.7 | — |
| SECONDARY Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA |
91.7; 92.0; 99.7; 92.1 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00090285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.