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

NCT ID: NCT01184079

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-05-31

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

Detailed Description

1. Specific Aims and Overview: The investigators propose a randomized, open label trial 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.

Blood would be drawn for titers at twice from all participants: pre-dose 1 and one month post Dose 3.

No cytology studies or DNA studies will be conducted.

1.1 Aims:

1. Determine if delay in the third dose is immunologically non-inferior to the standard administration schedule (1 month post-dose 3).

2. Determine the side effect profile of a delayed third dose, in comparison to the standard schedule.

3. Determine the preference and compliance of the men for the timing of the third dose.

1.2 Hypothesis for non- inferiority:

The GMTs in the 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

12 months

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

Group Type: EXPERIMENTAL

quadrivalent human papillomavirus vaccine

Intervention Type: BIOLOGICAL

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

6 month

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

Group Type: ACTIVE_COMPARATOR

quadrivalent human papillomavirus vaccine

Intervention Type: BIOLOGICAL

0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months

Interventions

quadrivalent human papillomavirus vaccine

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

Intervention Type: BIOLOGICAL

quadrivalent human papillomavirus vaccine

0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months

Intervention Type: BIOLOGICAL

Other Intervention Names

Gardasil; Gardasil

Eligibility Criteria

Inclusion Criteria

• Males age 18-26

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Richard Zimmerman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard K Zimmerman, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20629576 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24342252 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26176493 (View on PubMed)

Other Identifiers

PRO10070407

Identifier Type: OTHER

Identifier Source: secondary_id

I#0021806

Identifier Type: OTHER

Identifier Source: secondary_id

IISP#38206

Identifier Type: -

Identifier Source: org_study_id