N/A
N=220
Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
Quadrivalent HPV Vaccine · Human Papillomavirus Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT01184079 ↗Enrolled (actual)
220
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Immunogenicity After Dose 3 — 1063; 794; 1961; 1043 mM units/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- quadrivalent human papillomavirus vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Pittsburgh
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunogenicity After Dose 3 |
1063; 794; 1961; 1043; 6186; 4555 | — |
| SECONDARY Compliance With 3rd Dose |
97; 107 | — |
| SECONDARY Safety Profile |
28.9; 24.4 | 0.26 |
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
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
Data sourced from ClinicalTrials.gov (NCT01184079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.