Trial Outcomes & Findings for Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting (NCT NCT01184079)

Results Overview

Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

220 participants

Primary outcome timeframe

1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)

Results posted on

2014-03-27

Participant Flow

From October 2010 through May 2011, college age men, ages 18-25 years, were recruited using a variety of strategies including fliers, class announcements, recommendations by university health centers, emails to campus organizations, bus and campus newspaper advertisements, and targeted Facebook® advertisements.

Exclusion criteria were: \>4 lifetime sexual partners, health problems that would interfere with the immune response or ability to complete the study, a hospitalization during the past year, hypersensitivity to yeast or HPV vaccine components, inability to complete appointments, received HPV vaccine or immunosuppressive medications.

Participant milestones

Participant milestones
Measure	12 Month Administration Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months	6 Month Administration 3rd dose administration at 6 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
Overall Study STARTED	111	109
Overall Study Dose 2	110	108
Overall Study Dose 3	101	107
Overall Study Final Blood Draw	97	107
Overall Study COMPLETED	97	107
Overall Study NOT COMPLETED	14	2

Reasons for withdrawal

Reasons for withdrawal
Measure	12 Month Administration Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months	6 Month Administration 3rd dose administration at 6 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
Overall Study Lost to Follow-up	14	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	12 Month Administration n=111 Participants Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months	6 Month Administration n=109 Participants 3rd dose administration at 6 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months	Total n=220 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=5 Participants	100 Participants n=7 Participants	201 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	21.3 years STANDARD_DEVIATION 2.3 • n=5 Participants	21.4 years STANDARD_DEVIATION 2.2 • n=7 Participants	21.3 years STANDARD_DEVIATION 2.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants	109 Participants n=7 Participants	220 Participants n=5 Participants
Region of Enrollment United States	111 participants n=5 Participants	109 participants n=7 Participants	220 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)

Population: Intention-to-treat

Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups.

Outcome measures

Outcome measures
Measure	12 Month Administration n=111 Participants Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months	6 Month Administration n=109 Participants 3rd dose administration at 6 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
Immunogenicity After Dose 3 HPV 11	1961 mM units/ml Interval 1480.0 to 2403.0	1043 mM units/ml Interval 689.0 to 1382.0
Immunogenicity After Dose 3 HPV 6	1063 mM units/ml Interval 793.0 to 1312.0	794 mM units/ml Interval 565.0 to 1009.0
Immunogenicity After Dose 3 HPV 16	6186 mM units/ml Interval 4947.0 to 7315.0	4555 mM units/ml Interval 3243.0 to 5788.0
Immunogenicity After Dose 3 HPV 18	1049 mM units/ml Interval 728.0 to 1350.0	709 mM units/ml Interval 338.0 to 1103.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	12 Month Administration n=111 Participants Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months	6 Month Administration n=109 Participants 3rd dose administration at 6 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
Compliance With 3rd Dose	97 participants	107 participants

SECONDARY outcome

Timeframe: 1 week after vaccination

Population: Intention-to-treat

Total proportion of side effects reported after any dose, compared by arm.

Outcome measures

Outcome measures
Measure	12 Month Administration n=101 Participants Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months	6 Month Administration n=107 Participants 3rd dose administration at 6 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
Safety Profile	28.9 percentage of doses with side effects	24.4 percentage of doses with side effects

Adverse Events

12 Month Administration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

6 Month Administration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chyongchiou Jeng Lin, PhD

University of Pittsburgh Department of Family Medicine

Phone: 412/383-2360

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place