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

Not Applicable

Completed

• Conditions: Quadrivalent HPV Vaccine; Human Papillomavirus Vaccine
• Interventions: Biological: quadrivalent human papillomavirus vaccine

• Registration Number: NCT01184079
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-17
• Study First Posted: 2010-08-18
• Study Start: 2010-10
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2013-11-04
• Results First Submitted QC: 2014-01-03
• Status Verified: 2014-02
• Results First Posted: 2014-02-26
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 220

Inclusion Criteria

• Males age 18-26

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12 months	quadrivalent human papillomavirus vaccine	Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine
6 month	quadrivalent human papillomavirus vaccine	Administration of 3rd dose at 6 months quadrivalent human papillomavirus vaccine

Primary Outcome Measures

Name	Time	Method
Immunogenicity After Dose 3	1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)	Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups.

Secondary Outcome Measures

Name	Time	Method
Compliance With 3rd Dose	at 3rd dose (i.e., at month 6 or month 12, depending on arm)	Determine the compliance of the men for the timing of the third dose.
Safety Profile	1 week after vaccination	Total proportion of side effects reported after any dose, compared by arm.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States