Skip to main content
OpenTrials
Completed

NCT Number: NCT00090285

An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Condylomata Acuminata Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

16 year–26 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Biological

0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study

Other names: qHPV, V501

Comparator: placebo (unspecified)

Biological

0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study

Primary outcomes

  1. 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

    Time frame: Base study: through Month 36

    Participants with HPV 6/11/16/18-related external genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal or perineal cancer per 100 person-years of follow-up was assessed.

  2. Overall Study: Incidence of HPV Type 6/11-related Genital Warts

    Time frame: Up to 10 years after the first dose of qHPV vaccine

    Incidence of HPV Type 6/11-related genital warts is expressed as events per 10,000 person-years of follow-up.

  3. Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer

    Time frame: Up to 10 years after the first dose of qHPV vaccine

    Incidence of HPV Type 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer is expressed as events per 10,000 person-years of follow-up.

  4. Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer

    Time frame: Up to 10 years after the first dose of qHPV vaccine

    Incidence of HPV Type 6/11/16/18-related AIN and anal cancer is expressed as events per 10,000 person-years of follow-up. MSM is men having sex with men.

  5. Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)

    Time frame: Base study: through Day 5 after any vaccination

    An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an adverse experience. A severe AE is incapacitating with inability to work or do usual activities.

  6. Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)

    Time frame: Base study: through Month 36

    A serious adverse event is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.

  7. LTFU (EXT2): Number of Participants With Vaccine-Related SAEs

    Time frame: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine

    An SAE is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.

  8. LTFU (EXT2): Number of Participants Who Died

    Time frame: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine

    The number of participants who died was assessed.

Secondary outcomes

  1. Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection

    Time frame: Base study: through Month 36

    Participants with HPV Type 6/11/16/18-related persistent infection per 100 person-years of follow-up was assessed.

  2. Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection

    Time frame: Base study: through Month 36

    Participants with HPV 6/11/16/18-related DNA detection per 100 person-years of follow-up was assessed.

  3. Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)

    Time frame: Month 7

    Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).

  4. Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA

    Time frame: Month 36

    Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).

  5. Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA

    Time frame: Month 72

    Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).

  6. Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA

    Time frame: Month 120

    Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).

  7. Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA

    Time frame: Month 7

    Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.

  8. Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA

    Time frame: Month 36

    Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.

  9. Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA

    Time frame: Month 72

    Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.

  10. Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA

    Time frame: Month 120

    Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.

  11. Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)

    Time frame: Month 120

    Antibodies to HPV types were measured using Luminex immunoassay (IgG-LIA). The unit of measure for this assay is IgG LIA mMU/mL; this unit cannot be directly compared with the cLIA mMU/mL unit reported for the cLIA results.

  12. Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA

    Time frame: Month 120

    Antibodies to HPV types were measured using IgG LIA. Thresholds for seropositive were ≥9, 6, 5, and 5 IgG LIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.

Other outcomes

  1. Base Study: Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM)

    Time frame: Base study: through Month 36

    Participants with HPV 6/11/16/18-related AIN or anal cancer per 100 person-years of follow-up was assessed.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men

Important dates

Study start
2004
Primary completion
2009
Study completion
2017
First posted
Aug 27, 2004
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.