Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Johns Hopkins University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Johns Hopkins University
Collaborator:
Merck
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00806676
First received: December 9, 2008
Last updated: May 25, 2010
Last verified: May 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Kidney Disease |
Drug: Gardasil® Vaccine (FDA-approved vaccination regimen) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- Geometric mean antibody titers to HPV 6, 11, 16 and 18. [ Time Frame: Baseline, Months 7 and 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
|
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.
|
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.
|
Eligibility| Ages Eligible for Study: | 9 Years to 21 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Females, aged 9-21 years, in the following groups:
- CKD (defined as estimated glomerular filtration rate between 90 ml/min/1.73m2 and 15 ml/min/1.73m2, as calculated by the Schwartz formula)
- ESRD (eGFR < 15 ml/min/1.73m2, or receiving chronic dialysis [peritoneal or hemodialysis])
- Status-post kidney transplant
Exclusion Criteria:
- Within first 3 months post kidney transplant
- Within 3 months of kidney rejection episode
- Hypersensitivity to active substances or excipients of Gardasil vaccine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806676
Contacts
| Contact: Jeffrey J Fadrowski, MD, MHS | 410-955-2467 | jfadrow1@jhmi.edu |
Locations
| United States, Georgia | |
| Emory Healthcare & Children's Healthcare of Atlanta Pediatric Nephrology Clinic | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Sandra G Amaral, MD, MHS 404-727-8213 sandra_amaral@oz.ped.emory.edu | |
| Principal Investigator: Sandra G Amaral, MD, MHS | |
| United States, Maryland | |
| Johns Hopkins University Harriet Lane Kidney Center, Rubenstein Child Health Bldg | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Jeffrey J Fadrowski, MD, MHS 410-955-2467 jfadrow1@jhmi.edu | |
| Contact: Katie Alcorn, BA 443-287-5393 kalcorn1@jhmi.edu | |
| Principal Investigator: Jeffrey J Fadrowski, MD, MHS | |
Sponsors and Collaborators
Johns Hopkins University
Merck
Investigators
| Principal Investigator: | Jeffrey J Fadrowski, MD, MHS | Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Jeffrey Fadrowski MD, MHS/Assistant Professor of Pediatrics, Johns Hopkins University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00806676 History of Changes |
| Other Study ID Numbers: | MERCK_33610 |
| Study First Received: | December 9, 2008 |
| Last Updated: | May 25, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
chronic kidney disease children dialysis kidney transplant |
human papilloma virus Gardasil Chronic kidney disease (non-dialysis, dialysis, and kidney transplant) secondary to any cause. |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013