An interventional study of Gardasil® Vaccine (FDA-approved vaccination regimen) in Chronic Kidney Disease, sponsored by Johns Hopkins University. Completed at 2 sites in United States. Open to female participants aged 9 Years to 21 Years. Per ClinicalTrials.gov, last updated 2017-07-24.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Other
People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations. Those with chronic kidney disease have a disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to immune response abnormalities, the CKD population may or may not respond to the recommended three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and 18-related genital tract disease. The objective of this study is to measure the antibody response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD) (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant. Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained at months 0, 7 and 24.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 67 is close to the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Females, aged 9-21 years, in the following groups:
Exclusion Criteria:
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.
Drug: Gardasil® Vaccine (FDA-approved vaccination regimen)
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.
Drug: Gardasil® Vaccine (FDA-approved vaccination regimen)
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.
Drug: 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.
Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2
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.
Time frame: Month 7
Percentage of Patients 16-21 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2
Time frame: Month 7
Percentage of Patients 9-15 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2
Time frame: Month 7
Percentage of Patients 16-21 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2
Time frame: Month 7
Percentage of Patients 9-15 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2
Time frame: Month 7
Percentage of Patients 16-21 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2
Time frame: Month 7
| Milestone | 1. Chronic Kidney Disease, NKF Stage 1-4 | 2. ESRD (Dialysis) | 3. Kidney Transplant Recipient |
|---|---|---|---|
| Started | 29 | 9 | 29 |
| Completed | 25 | 9 | 23 |
| Not completed | 4 | 0 | 6 |
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.
| percentage of participants | HPV 6 | HPV 11 | HPV 16 | HPV 18 |
|---|---|---|---|---|
| Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2 | 100 (69 to 100) | 100 (69 to 100) | 100 (69 to 100) | 100 (69 to 100) |
| percentage of participants | HPV 6 | HPV 11 | HPV 16 | HPV 18 |
|---|---|---|---|---|
| Percentage of Patients 16-21 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2 | 100 (63 to 100) | 100 (63 to 100) | 100 (63 to 100) | 100 (63 to 100) |
| percentage of participants | HPV 6 | HPV 11 | HPV 16 | HPV 18 |
|---|---|---|---|---|
| Percentage of Patients 9-15 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2 | 100 (54 to 100) | 100 (54 to 100) | 100 (54 to 100) | 100 (54 to 100) |
| percentage of participants | HPV 6 | HPV 11 | HPV 16 | HPV 18 |
|---|---|---|---|---|
| Percentage of Patients 16-21 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2 | 100 (29 to 100) | 100 (29 to 100) | 100 (29 to 100) | 100 (29 to 100) |
| percentage of participants | HPV 6 | HPV 11 | HPV 16 | HPV 18 |
|---|---|---|---|---|
| Percentage of Patients 9-15 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2 | 88 (47 to 100) | 75 (35 to 97) | 100 (63 to 100) | 88 (47 to 100) |
| percentage of participants | HPV 6 | HPV 11 | HPV 16 | HPV 18 |
|---|---|---|---|---|
| Percentage of Patients 16-21 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2 | 50 (23 to 77) | 57 (29 to 82) | 100 (77 to 100) | 64 (35 to 87) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1. Chronic Kidney Disease, NKF Stage 1-4 | 0/25 (0%) | 0/25 (0%) | 4/25 (16%) |
| 2. ESRD (Dialysis) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| 3. Kidney Transplant Recipient | 0/23 (0%) | 0/23 (0%) | 4/23 (17.4%) |
| Event | 1. Chronic Kidney Disease, NKF Stage 1-4 | 2. ESRD (Dialysis) | 3. Kidney Transplant Recipient |
|---|---|---|---|
| Pain at vaccine injection siteInjury, poisoning and procedural complications | 4/25 | 0/9 | 4/23 |
| Age, Customized(Participants) | 1. Chronic Kidney Disease, NKF Stage 1-4 | 2. ESRD (Dialysis) | 3. Kidney Transplant Recipient | Total |
|---|---|---|---|---|
| >=11, <=21, years | 25 | 9 | 23 | 57 |
| Sex: Female, Male(Participants) | 1. Chronic Kidney Disease, NKF Stage 1-4 | 2. ESRD (Dialysis) | 3. Kidney Transplant Recipient | Total |
|---|---|---|---|---|
| Female | 25 | 9 | 23 | 57 |
| Male | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 1. Chronic Kidney Disease, NKF Stage 1-4 | 2. ESRD (Dialysis) | 3. Kidney Transplant Recipient | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 10 | 4 | 6 | 20 |
| White | 12 | 2 | 14 | 28 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 3 | 3 | 9 |
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