Chronic Kidney DiseaseNCT00806676

Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease

A study testing Gardasil® Vaccine (FDA-approved vaccination regimen) in people with Chronic Kidney Disease, run by Johns Hopkins University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 9 to 21 years, women only
Conditions the study is for: Chronic Kidney Disease
What is being tested?: Gardasil® Vaccine (FDA-approved vaccination regimen)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 2 sitesUnited States
Study dates: Dec 2008to Aug 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 21 years
Women only
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

Within first 3 months post kidney transplant
Within 3 months of kidney rejection episode
Hypersensitivity to active substances or excipients of Gardasil vaccine

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Emory Healthcare & Children's Healthcare of Atlanta Pediatric Nephrology Clinic
Atlanta, Georgia, 30322
Johns Hopkins University Harriet Lane Kidney Center, Rubenstein Child Health Bldg
Baltimore, Maryland, 21287

Other trials in United States

About this study

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.

Conditions: Chronic Kidney Disease
Being tested: Gardasil® Vaccine (FDA-approved vaccination regimen)
Keywords: chronic kidney disease, children, dialysis, kidney transplant, human papilloma virus, Gardasil, Chronic kidney disease (non-dialysis, dialysis, and kidney transplant) secondary to any cause.
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gardasil® Vaccine (FDA-approved vaccination regimen)Drug
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.

Study groups in NCT00806676
Study group	Role	What they receive
1. Chronic Kidney Disease, NKF Stage 1-4	Other	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. Receives: Drug: Gardasil® Vaccine (FDA-approved vaccination regimen)
2. ESRD (dialysis)	Other	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. Receives: Drug: Gardasil® Vaccine (FDA-approved vaccination regimen)
3. Kidney Transplant Recipient	Other	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. Receives: Drug: Gardasil® Vaccine (FDA-approved vaccination regimen)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Month 7
Percentage of Patients 16-21 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2
Measured: Month 7
Percentage of Patients 9-15 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2
Measured: Month 7
Percentage of Patients 16-21 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2
Measured: Month 7
Percentage of Patients 9-15 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2
Measured: Month 7
Percentage of Patients 16-21 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2
Measured: Month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Aug 2015

First posted11 Dec 2008 (estimated)
Study startDec 2008
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00806676
Sponsor's protocol ID: NA_00020699
Status last verified: Jul 2017
First submitted: 9 Dec 2008
Last updated: 24 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT00806676
Acronym / sponsor ID: NA_00020699
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease, children, dialysis, kidney transplant, human papilloma virus, Gardasil, Chronic kidney disease (non-dialysis, dialysis, and kidney transplant) secondary to any cause.
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Dec 2008
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 11 Dec 2008 (estimated)
Results: Posted 24 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1. Chronic Kidney Disease, NKF Stage 1-4	Other	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 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.
2. ESRD (dialysis)	Other	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.
3. Kidney Transplant Recipient	Other	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.

Who may qualify

Ages: 9 to 21 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

Within first 3 months post kidney transplant
Within 3 months of kidney rejection episode
Hypersensitivity to active substances or excipients of Gardasil vaccine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Drug	1. Chronic Kidney Disease, NKF Stage 1-4, 2. ESRD (dialysis), 3. Kidney Transplant Recipient

Primary outcome

Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2
Time frame: Month 7
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 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

Results and safety

Results posted to the registry on 24 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1. Chronic Kidney Disease, NKF Stage 1-4	29	25
2. ESRD (Dialysis)	9	9
3. Kidney Transplant Recipient	29	23

Primary outcome: Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2

Time frame: Month 7. Number (95% Confidence Interval). Unit: percentage of participants

Measure	HPV 6 n = 10	HPV 11 n = 10	HPV 16 n = 10	HPV 18 n = 10
Value	100 (69 to 100)	100 (69 to 100)	100 (69 to 100)	100 (69 to 100)

Population analysed: 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.

Primary outcome: Percentage of Patients 16-21 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2

Time frame: Month 7. Number (95% Confidence Interval). Unit: percentage of participants

Measure	HPV 6 n = 8	HPV 11 n = 8	HPV 16 n = 8	HPV 18 n = 8
Value	100 (63 to 100)	100 (63 to 100)	100 (63 to 100)	100 (63 to 100)

Primary outcome: Percentage of Patients 9-15 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2

Time frame: Month 7. Number (95% Confidence Interval). Unit: percentage of participants

Measure	HPV 6 n = 6	HPV 11 n = 6	HPV 16 n = 6	HPV 18 n = 6
Value	100 (54 to 100)	100 (54 to 100)	100 (54 to 100)	100 (54 to 100)

Primary outcome: Percentage of Patients 16-21 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2

Time frame: Month 7. Number (95% Confidence Interval). Unit: percentage of participants

Measure	HPV 6 n = 3	HPV 11 n = 3	HPV 16 n = 3	HPV 18 n = 3
Value	100 (29 to 100)	100 (29 to 100)	100 (29 to 100)	100 (29 to 100)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1. Chronic Kidney Disease, NKF Stage 1-4	0 of 25 (0%)	4 of 25 (16%)	0 of 25
2. ESRD (Dialysis)	0 of 9 (0%)	0 of 9 (0%)	0 of 9
3. Kidney Transplant Recipient	0 of 23 (0%)	4 of 23 (17.4%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey J Fadrowski, MD, MHS principal investigator

Johns Hopkins University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Gardasil® Vaccine (FDA-approved vaccination regimen) in people with Chronic Kidney Disease, run by Johns Hopkins University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2 (time frame: Month 7). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00806676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.