Clinical trial NCT02114385: A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)
Official title: A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [HPV] [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papilloma Viral Infection
Keywords: Prevention
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-04-15
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary objective

To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men

Detailed description: Secondary objectives

* To evaluate the tolerability of V503 in 16- to 26-year-old men.
* To summarise humoral immune responses, including anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 GMTs and seroconversion rates at 4 weeks post-dose 3, in 16- to 26-year-old men who received V503 or GARDASIL

Eligibility criteria: Inclusion Criteria:

* Subject is a man, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrolment.
* Subject is a man who has had no more than 5 lifetime female sexual partners.
* Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
* Subject, or subject's parent or guardian, fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent.

Exclusion Criteria:

* Subject who has had sex with a male partner.
* Subject has a history of HPV-related external genital lesions or HPV-related anal lesions
* Subject has a known allergy to any vaccine component, including aluminium, yeast, or BENZONASE
* Subject has a history of severe allergic reaction that required medical intervention.
* Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
* Subject is concurrently enrolled in clinical studies of investigational medicinal products.
* Subject has donated blood within 1 week prior to the Day 1 vaccination, or intends to donate during Day 1 through Month 7 of the study.
* Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
* Subject has had a splenectomy.
* Subject is receiving or has received in the year prior to enrolment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide, TNF-α antagonists, monoclonal antibody therapies, intravenous gamma globulin, antilymphocyte sera, or other therapy known to interfere with the immune response.
* Subject has received any immune globulin product or blood-derived product within the 6 months prior to the Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study.
* Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination.
* Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
* Subject has had a fever within the 24-hour period prior to the Day 1 vaccination.
* Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
* Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
* Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use.
* Subject, or subject's parent or guardian, is or has an immediate family member (spouse or children) who is investigational site or sponsor staff directly involved with this trial.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18
timeFrame: 4 weeks postdose 3 (Month 7)
Secondary outcomes:
measure: GMTs to HPV Types 31/33/45/52/58
timeFrame: 4 weeks postdose 3 (Month 7)
measure: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
timeFrame: 4 weeks postdose 3 (Month 7)
measure: Percentage of Participants With One or More Adverse Events
timeFrame: Up to 15 days after any vaccination
measure: Percentage of Participants With Study Discontinuation Due to an Adverse Event
timeFrame: Up to Month 7
measure: Percentage of Participants With One or More Injection-site Adverse Reactions
timeFrame: Up to 5 days after any vaccination
measure: Percentage of Participants With Maximum Temperature ≥37.8 °C
timeFrame: Up to 5 days after any vaccination
measure: Percentage of Participants With One or More Systemic Adverse Events
timeFrame: Up to 15 days after any vaccination
measure: Percentage of Participants With One or More Serious Adverse Events
timeFrame: Up to 15 days after any vaccination
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Sanofi Pasteur MSD Investigational Site 1002
city: Leuven
country: Belgium
facility: Sanofi Pasteur MSD Investigational Site 1003
city: Wilrijk
country: Belgium
facility: Sanofi Pasteur MSD Investigational Site 1001
city: Mainz
country: Germany
facility: Sanofi Pasteur MSD Investigational Site 3001
city: Amsterdam
country: Netherlands
facility: Sanofi Pasteur MSD Investigational Site 4001
city: Amsterdam
country: Netherlands
facility: Sanofi Pasteur MSD Investigational Site 4003
city: Nijmegen
country: Netherlands
facility: Sanofi Pasteur MSD Investigational Site 4002
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Van Damme P, Meijer CJLM, Kieninger D, Schuyleman A, Thomas S, Luxembourg A, Baudin M. A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men. Vaccine. 2016 Jul 29;34(35):4205-4212. doi: 10.1016/j.vaccine.2016.06.056. Epub 2016 Jun 25.
citation: Moreira ED, Giuliano AR, de Hoon J, Iversen OE, Joura EA, Restrepo J, Van Damme P, Vandermeulen C, Ellison MC, Krick A, Shields C, Heiles B, Luxembourg A. Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. Hum Vaccin Immunother. 2018 Feb 1;14(2):396-403. doi: 10.1080/21645515.2017.1403700. Epub 2017 Dec 14.