Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting

NCT01184079 | Completed Results

• 3 other identifiers: IISP#38206PRO10070407I#0021806
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months. Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the usual timing control group (C): H0: δ ≤ -δ0 versus H1: δ \> -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin

Conditions

Quadrivalent HPV Vaccine; Human Papillomavirus Vaccine

Keywords

human papillomavirus vaccine L1, type 6,11,16,18; HPV Vaccines; HPV L1 vaccine, quadrivalent 6,11,16,18

Outcome Measures

Primary Outcomes (1)

• Immunogenicity After Dose 3

  Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups.

  1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)

Secondary Outcomes (2)

• Compliance With 3rd Dose

  at 3rd dose (i.e., at month 6 or month 12, depending on arm)

• Safety Profile

  1 week after vaccination

Study Arms (2)

12 months

EXPERIMENTAL

Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine

Biological: quadrivalent human papillomavirus vaccine

6 month

ACTIVE COMPARATOR

Administration of 3rd dose at 6 months quadrivalent human papillomavirus vaccine

Biological: quadrivalent human papillomavirus vaccine

Interventions

quadrivalent human papillomavirus vaccine BIOLOGICAL

0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months

Also known as: Gardasil

12 months

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males age 18-26

You may not qualify if:

• Hospitalization within the past year
• Previous HPV vaccination
• \>/=5 sexual partners (i.e., insertive intercourse) No other drug studies within 30 days of proposed HPV vaccination
• History of genital warts
• Immunosuppression
• Other vaccines within 8 days of proposed HPV vaccination
• Hypersensitivity to yeast or HPV vaccine components
• Known autoimmune disorders
• Receipt of immunoglobulins or blood product within 90 days of enrollment (may defer until 90 days completed)
• Serious Adverse Reaction to HPV vaccine

Sponsors & Collaborators

• University of Pittsburgh: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (3)

• Zimmerman RK, Nowalk MP, Lin CJ, Fox DE, Ko FS, Wettick E, Cost G, Hand L, Hayes J, Michaels M. Randomized trial of an alternate human papillomavirus vaccine administration schedule in college-aged women. J Womens Health (Larchmt). 2010 Aug;19(8):1441-7. doi: 10.1089/jwh.2009.1753.

  PMID: 20629576 BACKGROUND

• Lin CJ, Zimmerman RK, Nowalk MP, Huang HH, Raviotta JM. Randomized controlled trial of two dosing schedules for human papillomavirus vaccination among college age males. Vaccine. 2014 Feb 3;32(6):693-9. doi: 10.1016/j.vaccine.2013.11.098. Epub 2013 Dec 14.

  PMID: 24342252 RESULT

• Zimmerman RK, Lin CJ, Raviotta JM, Nowalk MP. Do vitamin D levels affect antibody titers produced in response to HPV vaccine? Hum Vaccin Immunother. 2015;11(10):2345-9. doi: 10.1080/21645515.2015.1062955.

  PMID: 26176493 DERIVED

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Limitations and Caveats

Drop-out rates higher in the Alternate group; however, sample size was met for all HPV types. The effect of the Alternate dosing schedule on long-term clinical outcomes is unknown. One syncopal episode related to phlebotomy prior to vaccination.

Results Point of Contact

• Title: Chyongchiou Jeng Lin, PhD
• Organization: University of Pittsburgh Department of Family Medicine

cjlin@pitt.edu

412/383-2360

Study Officials

• Richard K Zimmerman, MD MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 18, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 27, 2014
• Results First Posted: February 26, 2014

Record last verified: 2014-02

Locations

US (1)