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

Human Papillomavirus Vaccine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184079
• Other study ID #: IISP#38206
• Secondary ID: PRO10070407I#002
• Status: Completed
• Phase: N/A
• First received: August 11, 2010
• Last updated: February 26, 2014
• Start date: October 2010
• Est. completion date: May 2012

Study information

• Verified date: February 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 26 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Human Papillomavirus Vaccine
• Quadrivalent HPV Vaccine

Intervention

Biological:
• quadrivalent human papillomavirus vaccine
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months
• quadrivalent human papillomavirus vaccine
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Compliance With 3rd Dose	Determine the compliance of the men for the timing of the third dose.	at 3rd dose (i.e., at month 6 or month 12, depending on arm)	No
Secondary	Safety Profile	Total proportion of side effects reported after any dose, compared by arm.	1 week after vaccination	Yes