Trial Outcomes & Findings for Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease (NCT NCT00806676)
NCT ID: NCT00806676
Last Updated: 2017-07-24
Results Overview
The primary outcome was antibody response to each of four HPV genotypes contained within the HPV vaccine at the time periods specified for the blood draws. Antibody levels, measured by Merck GmbH, were initially determined using the competitive Luminex immunoassay(cLIA; Merck GmbH), the assay used in the original licensing studies. Seropositivity was defined as being above thresholds set at 20, 16, 20, and 24 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively, as determined in phase 2 studies among patients who were immunocompetent. Antibody levels were reanalyzed using the newer, more sensitive IgG cLIA in stored serum from blood draws 2 and 3. Seropositivity for this assay was defined as being above thresholds set at 15, 15, 7, and 10 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively.
COMPLETED
NA
67 participants
Month 7
2017-07-24
Participant Flow
Participant milestones
| Measure |
1. Chronic Kidney Disease, NKF Stage 1-4
Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.
|
2. ESRD (Dialysis)
Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.
|
3. Kidney Transplant Recipient
Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
9
|
29
|
|
Overall Study
COMPLETED
|
25
|
9
|
23
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
1. Chronic Kidney Disease, NKF Stage 1-4
n=25 Participants
Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.
|
2. ESRD (Dialysis)
n=9 Participants
Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.
|
3. Kidney Transplant Recipient
n=23 Participants
Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
>=11, <=21, years
|
25 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
57 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
57 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Month 7Population: Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician's office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.
The primary outcome was antibody response to each of four HPV genotypes contained within the HPV vaccine at the time periods specified for the blood draws. Antibody levels, measured by Merck GmbH, were initially determined using the competitive Luminex immunoassay(cLIA; Merck GmbH), the assay used in the original licensing studies. Seropositivity was defined as being above thresholds set at 20, 16, 20, and 24 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively, as determined in phase 2 studies among patients who were immunocompetent. Antibody levels were reanalyzed using the newer, more sensitive IgG cLIA in stored serum from blood draws 2 and 3. Seropositivity for this assay was defined as being above thresholds set at 15, 15, 7, and 10 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively.
Outcome measures
| Measure |
HPV 6
n=10 Participants
HPV genotype
|
HPV 11
n=10 Participants
|
HPV 16
n=10 Participants
|
HPV 18
n=10 Participants
|
|---|---|---|---|---|
|
Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2
|
100 percentage of participants
Interval 69.0 to 100.0
|
100 percentage of participants
Interval 69.0 to 100.0
|
100 percentage of participants
Interval 69.0 to 100.0
|
100 percentage of participants
Interval 69.0 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician's office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.
Outcome measures
| Measure |
HPV 6
n=8 Participants
HPV genotype
|
HPV 11
n=8 Participants
|
HPV 16
n=8 Participants
|
HPV 18
n=8 Participants
|
|---|---|---|---|---|
|
Percentage of Patients 16-21 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2
|
100 percentage of participants
Interval 63.0 to 100.0
|
100 percentage of participants
Interval 63.0 to 100.0
|
100 percentage of participants
Interval 63.0 to 100.0
|
100 percentage of participants
Interval 63.0 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician's office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.
Outcome measures
| Measure |
HPV 6
n=6 Participants
HPV genotype
|
HPV 11
n=6 Participants
|
HPV 16
n=6 Participants
|
HPV 18
n=6 Participants
|
|---|---|---|---|---|
|
Percentage of Patients 9-15 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2
|
100 percentage of participants
Interval 54.0 to 100.0
|
100 percentage of participants
Interval 54.0 to 100.0
|
100 percentage of participants
Interval 54.0 to 100.0
|
100 percentage of participants
Interval 54.0 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician's office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.
Outcome measures
| Measure |
HPV 6
n=3 Participants
HPV genotype
|
HPV 11
n=3 Participants
|
HPV 16
n=3 Participants
|
HPV 18
n=3 Participants
|
|---|---|---|---|---|
|
Percentage of Patients 16-21 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2
|
100 percentage of participants
Interval 29.0 to 100.0
|
100 percentage of participants
Interval 29.0 to 100.0
|
100 percentage of participants
Interval 29.0 to 100.0
|
100 percentage of participants
Interval 29.0 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician's office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.
Outcome measures
| Measure |
HPV 6
n=8 Participants
HPV genotype
|
HPV 11
n=8 Participants
|
HPV 16
n=8 Participants
|
HPV 18
n=8 Participants
|
|---|---|---|---|---|
|
Percentage of Patients 9-15 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2
|
88 percentage of participants
Interval 47.0 to 100.0
|
75 percentage of participants
Interval 35.0 to 97.0
|
100 percentage of participants
Interval 63.0 to 100.0
|
88 percentage of participants
Interval 47.0 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Outcome measures
| Measure |
HPV 6
n=14 Participants
HPV genotype
|
HPV 11
n=14 Participants
|
HPV 16
n=14 Participants
|
HPV 18
n=14 Participants
|
|---|---|---|---|---|
|
Percentage of Patients 16-21 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2
|
50 percentage of participants
Interval 23.0 to 77.0
|
57 percentage of participants
Interval 29.0 to 82.0
|
100 percentage of participants
Interval 77.0 to 100.0
|
64 percentage of participants
Interval 35.0 to 87.0
|
Adverse Events
1. Chronic Kidney Disease, NKF Stage 1-4
2. ESRD (Dialysis)
3. Kidney Transplant Recipient
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1. Chronic Kidney Disease, NKF Stage 1-4
n=25 participants at risk
Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.
|
2. ESRD (Dialysis)
n=9 participants at risk
Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.
|
3. Kidney Transplant Recipient
n=23 participants at risk
Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Pain at vaccine injection site
|
16.0%
4/25
|
0.00%
0/9
|
17.4%
4/23
|
Additional Information
Dr. Jeffrey Fadrowski
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place