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

University of Pittsburgh

Status: Completed

Conditions: Quadrivalent HPV Vaccine; Human Papillomavirus Vaccine

Treatments: Biological: quadrivalent human papillomavirus vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01184079

PRO10070407 (Other Identifier)

I#0021806 (Other Identifier)

IISP#38206

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 patients

Sex: Male

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

12 months

Experimental group

Description:

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

Treatment:

Biological: quadrivalent human papillomavirus vaccine

Biological: quadrivalent human papillomavirus vaccine

6 month

Active Comparator group

Description:

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

Treatment:

Biological: quadrivalent human papillomavirus vaccine

Biological: quadrivalent human papillomavirus vaccine