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

Anal Cancer Clinical Trial

Official title:

A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651949
• Other study ID #: V503-003
• Secondary ID: 2012-002758-22
• Status: Completed
• Phase: Phase 3
• Start date: October 29, 2012
• Est. completion date: August 4, 2014

Study information

• Verified date: October 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2520
• Est. completion date: August 4, 2014
• Est. primary completion date: August 4, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anal Intraepithelial Neoplasia
• Anus Neoplasms
• Carcinoma in Situ
• Condylomata Acuminata
• Genital Warts

Intervention

Biological:
• 9vHPV Vaccine
9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Castellsagué X, Giuliano AR, Goldstone S, Guevara A, Mogensen O, Palefsky JM, Group T, Shields C, Liu K, Maansson R, Luxembourg A, Kaplan SS. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015 Nov 27;33(48):6892-901. doi: 10.1016/j.vaccine.2015.06.088. Epub 2015 Jul 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine	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	Four weeks post vaccination 3 (Month 7)
Primary	Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card	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.	Up to 5 days after any vaccination
Primary	Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)	Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination	Up to 5 days after any vaccination
Primary	Percentage of Participants With an Adverse Event	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.	Up to Month 12
Primary	Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event	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.	Up to Month 12
Secondary	Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine	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.	Four weeks post vaccination 3 (Month 7)