Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

Phase 3

Completed

• Conditions: Genital Warts; Anal Cancer; Anal Intraepithelial Neoplasia
• Interventions: Biological: 9vHPV Vaccine

• Registration Number: NCT01651949
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.

Detailed Description

Study participants will be administered a 3-dose regimen of 9vHPV. They will be assessed for immunogenicity 1 month following completion of vaccination. All participants will be followed for safety for a total of 12 months.

Study Timeline

• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-27
• Study Start: 2012-10-29
• Primary Completion: 2014-08-04
• Study Completion: 2014-08-04
• Results First Submitted: 2015-02-24
• Results First Submitted QC: 2015-02-24
• Results First Posted: 2015-03-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2520

Inclusion Criteria

• Good physical health
• Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
• Other inclusion criteria will be discussed with the investigator

Exclusion Criteria

• History of severe allergic reaction that required medical intervention
• Currently enrolled in a clinical trial
• If participant is female, pregnant
• Currently immunocompromised or having received immunosuppressive therapy in the last year
• Positive test for HPV
• History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer
• If participant is female, history of abnormal cervical biopsy results
• Other exclusion criteria will be discussed with the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Females	9vHPV Vaccine	Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Men who have Sex with Men	9vHPV Vaccine	Healthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Heterosexual Males	9vHPV Vaccine	Healthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine	Four weeks post vaccination 3 (Month 7)	Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL
Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)	Up to 5 days after any vaccination	Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination
Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card	Up to 5 days after any vaccination	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, 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 study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.
Percentage of Participants With an Adverse Event	Up to Month 12	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, 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 study vaccine is also an AE.
Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event	Up to Month 12	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, 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 study vaccine is also an AE.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine	Four weeks post vaccination 3 (Month 7)	Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.