Trial Outcomes & Findings for Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males (NCT NCT01209325)
NCT ID: NCT01209325
Last Updated: 2020-08-11
Results Overview
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 6 positive DNA in participants without HPV-6 related AIN at baseline.
COMPLETED
PHASE2
149 participants
Post Month 7 through Month 24
2020-08-11
Participant Flow
Participant milestones
| Measure |
Vaccination
Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
laboratory biomarker analysis
|
|---|---|
|
Overall Study
STARTED
|
149
|
|
Overall Study
Eligible
|
145
|
|
Overall Study
Received First Vaccine Injection
|
144
|
|
Overall Study
Received Second Vaccine Injection
|
141
|
|
Overall Study
Received Third Vaccine Infjection
|
138
|
|
Overall Study
Returned After Week 28
|
124
|
|
Overall Study
COMPLETED
|
106
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
Vaccination
Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
laboratory biomarker analysis
|
|---|---|
|
Overall Study
Lost to Follow-up
|
24
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Relocated
|
3
|
|
Overall Study
Refusal after starting therapy
|
8
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Refusal prior to therapy
|
1
|
|
Overall Study
Incarceration
|
2
|
Baseline Characteristics
Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males
Baseline characteristics by cohort
| Measure |
Vaccination
n=144 Participants
Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
laboratory biomarker analysis
|
|---|---|
|
Age, Continuous
|
23.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
106 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
80 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
Puerto Rico
|
3 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
141 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Post Month 7 through Month 24Population: Eligible participants without prevalent HPV 6 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 6 positive DNA in participants without HPV-6 related AIN at baseline.
Outcome measures
| Measure |
Naive to HPV 11
n=15 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=34 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA
|
0.0 Events per 100 person years
|
11.1 Events per 100 person years
|
PRIMARY outcome
Timeframe: Post Month 7 through Month 24Population: Eligible participants without prevalent HPV 11 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 11 positive DNA in participants without HPV-11 related AIN at baseline.
Outcome measures
| Measure |
Naive to HPV 11
n=35 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=28 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA
|
0.0 Events per 100 person years
|
2.2 Events per 100 person years
|
PRIMARY outcome
Timeframe: Post Month 7 through Month 24Population: Eligible participants without prevalent HPV 16 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 16 positive DNA in participants without HPV-16 related AIN at baseline.
Outcome measures
| Measure |
Naive to HPV 11
n=39 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=29 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA
|
0.0 Events per 100 person years
|
4.5 Events per 100 person years
|
PRIMARY outcome
Timeframe: Post Month 7 through Month 24Population: Eligible participants without prevalent HPV 18 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 18 positive DNA in participants without HPV-18 related AIN at baseline.
Outcome measures
| Measure |
Naive to HPV 11
n=47 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=23 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA
|
0.0 Events per 100 person years
|
2.8 Events per 100 person years
|
PRIMARY outcome
Timeframe: Post Month 7 through Month 24Population: All eligible participants who were HPV 6 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.
Incident events are defined as having HPV 6 positive PCR results at 2 or more consecutive visits in those who were DNA negative for HPV 6. Persistence was defined based on being persistent in the same anatomical site.
Outcome measures
| Measure |
Naive to HPV 11
n=29 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=15 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of Persistent Anogenital Infection With HPV 6 DNA
|
1.8 events per 100 person years
|
0.0 events per 100 person years
|
PRIMARY outcome
Timeframe: Post Month 7 through Month 24Population: All eligible participants who were HPV 11 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.
Incident events are defined as having positive PCR results with HPV 11 at 2 or more consecutive visits in those who were DNA negative for HPV 11 at baseline. Persistence was defined based on being persistent in the same anatomical site.
Outcome measures
| Measure |
Naive to HPV 11
n=55 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=33 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of Persistent Anogenital Infection With HPV 11 DNA
|
0.0 events per 100 person years
|
0.0 events per 100 person years
|
PRIMARY outcome
Timeframe: Post Month 7 through Month 24Population: All eligible participants who were HPV 16 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.
Incident events are defined as having positive PCR results with HPV 16 at 2 or more consecutive visits in those who were DNA negative for HPV 16 at baseline. Persistence was defined based on being persistent in the same anatomical site.
Outcome measures
| Measure |
Naive to HPV 11
n=54 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=23 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of Persistent Anogenital Infection With HPV 16 DNA
|
2.9 events per 100 person years
|
0.0 events per 100 person years
|
PRIMARY outcome
Timeframe: Post Month 7 through Month 24Population: All eligible participants who were HPV 18 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.
Incident events are defined as having positive PCR results with HPV 18 at 2 or more consecutive visits in those who were DNA negative for HPV 18. Persistence was defined based on being persistent in the same anatomical site.
Outcome measures
| Measure |
Naive to HPV 11
n=74 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=23 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of Persistent Anogenital Infection With HPV 18 DNA
|
0.7 events per 100 person years
|
0.0 events per 100 person years
|
PRIMARY outcome
Timeframe: Post month 7 through month 24Population: Eligible participants without prevalent HPV 6 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.
Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 6 positive DNA in participants without HPV 6 related HGAIN at baseline.
Outcome measures
| Measure |
Naive to HPV 11
n=15 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=56 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of HGAIN Associated With HPV 6
|
0.0 per 100 person years
|
10.4 per 100 person years
|
PRIMARY outcome
Timeframe: Post month 7 through month 24Population: Eligible participants without prevalent HPV 11 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.
Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 11 positive DNA in participants without HPV 11 related HGAIN at baseline.
Outcome measures
| Measure |
Naive to HPV 11
n=35 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=36 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of HGAIN Associated With HPV 11
|
0.0 per 100 person years
|
1.7 per 100 person years
|
PRIMARY outcome
Timeframe: Post month 7 through month 24Population: Eligible participants without prevalent HPV 16 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.
Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 16 positive DNA in participants without HPV 16 related HGAIN at baseline.
Outcome measures
| Measure |
Naive to HPV 11
n=39 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=32 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of HGAIN Associated With HPV 16
|
0.0 per 100 person years
|
8.4 per 100 person years
|
PRIMARY outcome
Timeframe: Post month 7 through month 24Population: Eligible participants without prevalent HPV 18 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.
Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 18 positive DNA in participants without HPV 18 related HGAIN at baseline.
Outcome measures
| Measure |
Naive to HPV 11
n=47 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=24 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of HGAIN Associated With HPV 18
|
0.0 per 100 person years
|
2.7 per 100 person years
|
PRIMARY outcome
Timeframe: Post month 7 through month 24Population: Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Outcome measures
| Measure |
Naive to HPV 11
n=29 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=91 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of Penile/Scrotal Condyloma in HPV 6 Naive and Prior Exposed Participants
|
1.8 per 100 person years
|
1.1 per 100 person years
|
PRIMARY outcome
Timeframe: Post month 7 through month 24Population: Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Outcome measures
| Measure |
Naive to HPV 11
n=58 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=61 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of Penile/Scrotal Condyloma in HPV 11 Naive and Prior Exposed Participants
|
0.9 per 100 person years
|
1.7 per 100 person years
|
PRIMARY outcome
Timeframe: Post month 7 through month 24Population: Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Outcome measures
| Measure |
Naive to HPV 11
n=56 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=63 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of Penile/Scrotal Condyloma in HPV 16 Naive and Prior Exposed Participants
|
1.8 per 100 person years
|
0.8 per 100 person years
|
PRIMARY outcome
Timeframe: Post month 7 through month 24Population: Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Outcome measures
| Measure |
Naive to HPV 11
n=76 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=44 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants
|
0.7 per 100 person years
|
2.3 per 100 person years
|
SECONDARY outcome
Timeframe: Through Month 24Population: The safety population included eligible participants who received at least one vaccination.
Number of participants who experienced grade 3 and higher AEs that were possibly, probably or definitely related to the vaccine.
Outcome measures
| Measure |
Naive to HPV 11
n=144 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Occurrence of Grade ≥ 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline through month 24Population: Eligible participants who received at least one vaccination with evaluable serum assessments.
Geometric mean concentration of antibodies for HPV 6 at each visit
Outcome measures
| Measure |
Naive to HPV 11
n=50 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=93 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Geometric Mean Titers for HPV 6
Baseline
|
0 mMU/mL
Interval 0.0 to 0.0
|
81.7 mMU/mL
Interval 64.5 to 851.8
|
|
Geometric Mean Titers for HPV 6
Month 7
|
302.3 mMU/mL
Interval 236.4 to 386.6
|
637.8 mMU/mL
Interval 477.6 to 851.8
|
|
Geometric Mean Titers for HPV 6
Month 12
|
111.8 mMU/mL
Interval 83.6 to 149.4
|
420.9 mMU/mL
Interval 318.2 to 556.7
|
|
Geometric Mean Titers for HPV 6
Month 18
|
79.7 mMU/mL
Interval 55.8 to 113.9
|
335.3 mMU/mL
Interval 262.8 to 428.0
|
|
Geometric Mean Titers for HPV 6
Month 24
|
73.7 mMU/mL
Interval 48.5 to 112.0
|
356.6 mMU/mL
Interval 272.4 to 466.8
|
SECONDARY outcome
Timeframe: Baseline through month 24Population: Eligible participants who received at least one vaccination with evaluable serum assessments.
Geometric mean concentration of antibodies for HPV 11 at each visit
Outcome measures
| Measure |
Naive to HPV 11
n=79 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=64 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Geometric Mean Titers for HPV 11
Baseline
|
0 mMU/mL
Interval 0.0 to 0.0
|
42.7 mMU/mL
Interval 30.1 to 60.5
|
|
Geometric Mean Titers for HPV 11
Month 7
|
452.4 mMU/mL
Interval 378.1 to 541.4
|
976.2 mMU/mL
Interval 757.5 to 1258.1
|
|
Geometric Mean Titers for HPV 11
Month 12
|
132.0 mMU/mL
Interval 102.7 to 169.8
|
493.7 mMU/mL
Interval 355.2 to 686.1
|
|
Geometric Mean Titers for HPV 11
Month 18
|
89.6 mMU/mL
Interval 67.2 to 119.4
|
373.2 mMU/mL
Interval 262.1 to 531.6
|
|
Geometric Mean Titers for HPV 11
Month 24
|
84.4 mMU/mL
Interval 62.1 to 114.9
|
300.2 mMU/mL
Interval 205.8 to 438.1
|
SECONDARY outcome
Timeframe: Baseline through 24 monthsPopulation: Eligible participants who received at least one vaccination with evaluable serum assessments.
Geometric mean concentration of antibodies for HPV 16 at each visit
Outcome measures
| Measure |
Naive to HPV 11
n=92 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=51 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Geometric Mean Titers for HPV 16
Baseline
|
0 mMU/mL
Interval 0.0 to 0.0
|
66.6 mMU/mL
Interval 46.7 to 95.1
|
|
Geometric Mean Titers for HPV 16
Month 7
|
1535.6 mMU/mL
Interval 1272.5 to 1853.1
|
2947.8 mMU/mL
Interval 2249.0 to 3863.6
|
|
Geometric Mean Titers for HPV 16
Month 12
|
451.6 mMU/mL
Interval 352.5 to 578.5
|
1436.6 mMU/mL
Interval 1095.2 to 1884.6
|
|
Geometric Mean Titers for HPV 16
Month 18
|
309.5 mMU/mL
Interval 237.6 to 403.1
|
1242.9 mMU/mL
Interval 892.2 to 1731.5
|
|
Geometric Mean Titers for HPV 16
Month 24
|
272.4 mMU/mL
Interval 195.5 to 379.6
|
1079.5 mMU/mL
Interval 771.8 to 1510.0
|
SECONDARY outcome
Timeframe: Baseline through 24 monthsPopulation: Eligible participants who received at least one vaccination with evaluable serum assessments.
Geometric mean concentration of antibodies for HPV 18 at each visit
Outcome measures
| Measure |
Naive to HPV 11
n=104 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=39 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Geometric Mean Titers for HPV 18
Baseline
|
0 mMU/mL
Interval 0.0 to 0.0
|
41.3 mMU/mL
Interval 28.1 to 60.7
|
|
Geometric Mean Titers for HPV 18
Month 7
|
294.2 mMU/mL
Interval 232.8 to 371.8
|
482.2 mMU/mL
Interval 351.9 to 660.7
|
|
Geometric Mean Titers for HPV 18
Month 12
|
63.1 mMU/mL
Interval 48.7 to 81.6
|
214.6 mMU/mL
Interval 141.0 to 326.6
|
|
Geometric Mean Titers for HPV 18
Month 18
|
39.2 mMU/mL
Interval 29.7 to 51.7
|
244.3 mMU/mL
Interval 158.0 to 377.5
|
|
Geometric Mean Titers for HPV 18
Month 24
|
39.0 mMU/mL
Interval 28.7 to 52.8
|
161.9 mMU/mL
Interval 103.3 to 253.7
|
SECONDARY outcome
Timeframe: at 7 and 24 MonthsPopulation: Eligible participants who received at least one vaccination and who were sero-negative for HPV 6 at baseline with evaluable serum assessments.
Geometric mean concentration of antibodies for HPV 6 at 7 and 24 months
Outcome measures
| Measure |
Naive to HPV 11
n=43 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=38 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Age<24 years
|
319 mMU/mL
Interval 227.0 to 451.0
|
71 mMU/mL
Interval 42.0 to 121.0
|
|
Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Age>=24 years
|
304 mMU/mL
Interval 200.0 to 463.0
|
77 mMU/mL
Interval 37.0 to 163.0
|
|
Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline HIV viral load <=75
|
324 mMU/mL
Interval 244.0 to 431.0
|
81 mMU/mL
Interval 53.0 to 125.0
|
|
Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline HIV viral load >75
|
250 mMU/mL
Interval 118.0 to 528.0
|
45 mMU/mL
Interval 8.0 to 257.0
|
|
Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline CD4 <=500
|
341 mMU/mL
Interval 178.0 to 657.0
|
97 mMU/mL
Interval 44.0 to 212.0
|
|
Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline CD4 >500
|
302 mMU/mL
Interval 229.0 to 399.0
|
66 mMU/mL
Interval 39.0 to 111.0
|
|
Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Nadir CD4 <=350
|
361 mMU/mL
Interval 222.0 to 584.0
|
77 mMU/mL
Interval 38.0 to 155.0
|
|
Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Nadir CD4>350
|
300 mMU/mL
Interval 214.0 to 421.0
|
75 mMU/mL
Interval 42.0 to 134.0
|
SECONDARY outcome
Timeframe: at 7 and 24 MonthsPopulation: Eligible participants who received at least one vaccination and who were sero-negative for HPV 11 at baseline with evaluable serum assessments.
Geometric mean concentration of antibodies for HPV 11 at 7 and 24 months
Outcome measures
| Measure |
Naive to HPV 11
n=68 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=60 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Age<24 years
|
434 mMU/mL
Interval 336.0 to 561.0
|
71 mMU/mL
Interval 49.0 to 105.0
|
|
Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Age>=24 years
|
482 mMU/mL
Interval 361.0 to 645.0
|
104 mMU/mL
Interval 61.0 to 174.0
|
|
Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline HIV viral load <=75
|
473 mMU/mL
Interval 385.0 to 583.0
|
86 mMU/mL
Interval 63.0 to 118.0
|
|
Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline HIV viral load >75
|
365 mMU/mL
Interval 226.0 to 587.0
|
75 mMU/mL
Interval 21.0 to 260.0
|
|
Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline CD4 <=500
|
475 mMU/mL
Interval 354.0 to 638.0
|
98 mMU/mL
Interval 59.0 to 163.0
|
|
Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline CD4 >500
|
445 mMU/mL
Interval 347.0 to 571.0
|
78 mMU/mL
Interval 53.0 to 117.0
|
|
Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Nadir CD4 <=350
|
469 mMU/mL
Interval 351.0 to 626.0
|
87 mMU/mL
Interval 57.0 to 133.0
|
|
Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Nadir CD4>350
|
452 mMU/mL
Interval 344.0 to 594.0
|
82 mMU/mL
Interval 50.0 to 134.0
|
SECONDARY outcome
Timeframe: at 7 and 24 MonthsPopulation: Eligible participants who received at least one vaccination and who were sero-negative for HPV 16 at baseline with evaluable serum assessments.
Geometric mean concentration of antibodies for HPV 16 at 7 and 24 months
Outcome measures
| Measure |
Naive to HPV 11
n=76 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=66 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Age<24 years
|
1572 mMU/mL
Interval 1239.0 to 1995.0
|
268 mMU/mL
Interval 185.0 to 388.0
|
|
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Age>=24 years
|
1467 mMU/mL
Interval 1013.0 to 2126.0
|
272 mMU/mL
Interval 131.0 to 566.0
|
|
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline HIV viral load <=75
|
1630 mMU/mL
Interval 1328.0 to 2002.0
|
282 mMU/mL
Interval 200.0 to 398.0
|
|
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline HIV viral load >75
|
914 mMU/mL
Interval 441.0 to 1894.0
|
201 mMU/mL
Interval 51.0 to 795.0
|
|
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline CD4 <=500
|
1556 mMU/mL
Interval 1123.0 to 2156.0
|
359 mMU/mL
Interval 218.0 to 590.0
|
|
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline CD4 >500
|
1522 mMU/mL
Interval 1178.0 to 1967.0
|
229 mMU/mL
Interval 145.0 to 359.0
|
|
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Nadir CD4 <=350
|
1390 mMU/mL
Interval 1040.0 to 1857.0
|
245 mMU/mL
Interval 151.0 to 395.0
|
|
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Nadir CD4>350
|
1752 mMU/mL
Interval 1303.0 to 2354.0
|
313 mMU/mL
Interval 186.0 to 528.0
|
SECONDARY outcome
Timeframe: at 7 and 24 MonthsPopulation: Eligible participants who received at least one vaccination and who were sero-negative for HPV 18 at baseline with evaluable serum assessments.
Geometric mean concentration of antibodies for HPV 18 at 7 and 24 months
Outcome measures
| Measure |
Naive to HPV 11
n=88 Participants
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
|
Prior Exposure to HPV 11
n=73 Participants
HPV 11 positive based on serum at visit 0 from any anatomical site.
|
|---|---|---|
|
Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Age<24 years
|
310 mMU/mL
Interval 230.0 to 418.0
|
37 mMU/mL
Interval 25.0 to 55.0
|
|
Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Age>=24 years
|
281 mMU/mL
Interval 180.0 to 437.0
|
42 mMU/mL
Interval 26.0 to 69.0
|
|
Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline HIV viral load <=75
|
333 mMU/mL
Interval 258.0 to 431.0
|
42 mMU/mL
Interval 30.0 to 57.0
|
|
Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline HIV viral load >75
|
123 mMU/mL
Interval 57.0 to 267.0
|
25 mMU/mL
Interval 7.0 to 86.0
|
|
Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline CD4 <=500
|
327 mMU/mL
Interval 209.0 to 511.0
|
45 mMU/mL
Interval 26.0 to 77.0
|
|
Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Baseline CD4 >500
|
282 mMU/mL
Interval 208.0 to 381.0
|
36 mMU/mL
Interval 25.0 to 52.0
|
|
Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Nadir CD4 <=350
|
338 mMU/mL
Interval 240.0 to 476.0
|
42 mMU/mL
Interval 29.0 to 62.0
|
|
Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Nadir CD4>350
|
268 mMU/mL
Interval 185.0 to 387.0
|
36 mMU/mL
Interval 21.0 to 62.0
|
Adverse Events
Vaccination
Serious adverse events
| Measure |
Vaccination
n=144 participants at risk
Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
laboratory biomarker analysis
|
|---|---|
|
Infections and infestations
Skin infection
|
1.4%
2/144 • Number of events 2 • From enrollment through 2 years after the first injection of Gardasil.
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
|
|
Infections and infestations
Gum infection
|
0.69%
1/144 • Number of events 1 • From enrollment through 2 years after the first injection of Gardasil.
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
|
|
Gastrointestinal disorders
Vomiting
|
0.69%
1/144 • Number of events 1 • From enrollment through 2 years after the first injection of Gardasil.
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
|
|
Gastrointestinal disorders
Nausea
|
0.69%
1/144 • Number of events 1 • From enrollment through 2 years after the first injection of Gardasil.
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
|
|
Psychiatric disorders
Psychiatric disorders - other, specify
|
0.69%
1/144 • Number of events 1 • From enrollment through 2 years after the first injection of Gardasil.
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
|
|
Psychiatric disorders
Suicidal ideation
|
0.69%
1/144 • Number of events 3 • From enrollment through 2 years after the first injection of Gardasil.
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
|
|
Psychiatric disorders
Suicide attempt
|
0.69%
1/144 • Number of events 2 • From enrollment through 2 years after the first injection of Gardasil.
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
|
Other adverse events
| Measure |
Vaccination
n=144 participants at risk
Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
laboratory biomarker analysis
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
8/144 • From enrollment through 2 years after the first injection of Gardasil.
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
|
|
General disorders
Injection site reaction
|
25.7%
37/144 • From enrollment through 2 years after the first injection of Gardasil.
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
|
|
Investigations
Neutrophil count decreased
|
6.9%
10/144 • From enrollment through 2 years after the first injection of Gardasil.
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
10/144 • From enrollment through 2 years after the first injection of Gardasil.
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorder - other, specify
|
9.0%
13/144 • From enrollment through 2 years after the first injection of Gardasil.
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
|
Additional Information
Dr. Joel M. Palefsky
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place