Chronic Kidney Disease, Stage IV (Severe)NCT01298869
The Study of Immunogenicity of Quadrivalent Vaccine Against Human Papilloma Virus (HPV) Types 6, 11, 16, and 18 (HPV-6/11/16/18) in Chronic Kidney Disease (CKD) Patients
An observational study of Chronic Kidney Disease, Stage IV (Severe) and Chronic Kidney Disease, Stage V, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Clinical trials have demonstrated the efficacy of HPV-6/11/16/18 vaccination (Gardasil. Merck) 3 doses at day 1, month 2, and month 6 to lower the occurrence of high-grade cervical intraepithelial neoplasia than did those in the placebo group. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Chronic Kidney Disease, Stage IV (Severe), Chronic Kidney Disease, Stage V
- What is being tested?
- HPV-6/11/16/18 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
Study population: Chronic kidney disease stage IV and V population
Who may be able to join
- Subject is between the ages 18 - 26 years as of visit 1 and has GFR < 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease (MDRD) equation: eGFR = 175 x serum creatinine(-1.154) x Age(-0.203) x 0.742 (if female)
- Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory testing.
- Subject is able to understand study procedures and agrees to participate in the study by giving written informed consent.
- Subject is not pregnant now (as determined by a serum pregnancy test or urine pregnancy test sensitive to 25 IU -hCG) and agrees to use effective contraception through Month 7 of the study. Effective contraception will be considered: oral contraceptives, injection or implant contraception.
- Subject has had no temperature > 37.8 C (oral) within 24 hours prior to the first injection.
- Subject has no history of genital/anorectal warts,
Who cannot join
- Subject is pregnant.
- Subject has a history of known prior vaccination with an HPV vaccine.
- Subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
- Subject is allergic to any vaccine component, including aluminum, yeast, or BENZONASE.
- Subject has received any immune globulin or blood derived products within the 3 months prior to the first injection, or plans to receive any through Month 7 of the study.
- Subject has a history of splenectomy, known immune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis), or receiving immunosuppressives (e.g., substances or treatments known to diminish the immune response such as radiation therapy, administration of antimetabolites, antilymphocytic sera, systemic corticosteroids). Individuals who have received periodic treatments with immunosuppressives, defined as at least 3 courses of oral corticosteroids each lasting at least 1 week in duration for the year prior to enrollment, will be excluded. Subjects using topical steroids (i.e., inhaled, nasal, or topical) will be eligible for vaccination.
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- Subject is immunocompromised or has been diagnosed as having HIV infection.
- Subject has a known thrombocytopenia or other coagulation disorder that would contraindicate intramuscular injections.
- Subject has a history of recent (within 1 year from the date of enrollment) or ongoing alcohol abuse or other drug abuse.
- Subject is unable to give informed consent.
- Subject has any prior history of genital/anorectal warts
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chulalongkorn Memorial Hospital
Bangkok, 10330
Kearkiat Praditpornsilpa, MD, 662-2564251 ext. 203, kearkiat@hotmail.com
Kearkiat Praditpornsilpa, MD
About this study
Official title: The Study of Immunogenicity of Quadrivalent Vaccine Against Human Papilloma Virus (HPV) Types 6, 11, 16, and 18 (HPV-6/11/16/18) in CKD Patients
Clinical trials have demonstrated the efficacy of HPV-6/11/16/18 vaccination (Gardasil. Merck) 3 doses at day 1, month 2, and month 6 to lower the occurrence of high-grade cervical intraepithelial neoplasia than did those in the placebo group. The immunogenicity and efficacy of the HPV vaccine has not been proven in late stage chronic kidney disease (CKD) population. The cellular and humoral immune responsiveness of CKD population are impaired by the retention of uremic toxin due to glomerular filtration rate (GFR) reduction, the vaccination efficacy can be altered and the effective dose/schedule of the vaccine may need to be adjusted, mostly increase in CKD patients.
This study aims to investigate the immunogenicity of quadrivalent HPV-6/11/16/18 vaccination (Gardasil. Merck) by current recommended dose/schedule in CKD stage IV-V patients and compare to non-CKD patients. Although a minimal peak anti-HPV response associated with protective efficacy has not been determined, the equivalent immune response in CKD and non-CKD patients if can be demonstrated by this study should be extrapolated to the CKD population. If less immune response results, the more intense dose/schedule of the vaccine should be further studied.
Read the detailed description
Up to 70% of sexually active adults will become infected with human papillomavirus (HPV) during their lifetime. HPV infection can result in anogenital cancer and genital warts. These diseases are associated with substantial morbidity and mortality. Every year, 471,000 cases of cervical cancer are diagnosed worldwide. The 5-year survival for this disease is ~70%. The incidence of HPV-related anal cancer has doubled in the last 25 years. Screening programs to detect early disease are not available. Genital warts cause significant morbidity. Therefore, a prophylactic vaccine that reduces HPV infection will greatly reduce the burden of HPV disease. This study aims to demonstrate the immunogenicity of quadrivalent HPV-6/11/16/18 vaccination (Gardasil. Merck) by current recommended dose/schedule (day 1, and month 7) in CKD stage IV-V patients and to compare the immunogenicity of the vaccine in CKD stage IV-V patients and non-CKD subjects in historical cohort data.
- Being tested
- HPV-6/11/16/18 vaccine
- Keywords
- CKD, HPV infection, HPV vaccine, antibodies titer
- Medical subject headings
- Renal Insufficiency, Chronic, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV-6/11/16/18 vaccineBiological
Also called Gardasil
HPV-6/11/16/18 vaccination 3 doses at day 1, month 2, and month 6
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease | Chronic kidney disease stage IV and V Receives: Biological: HPV-6/11/16/18 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titers of neutralizing antibodies for each HPV type
The geometric mean titers of neutralizing antibodies for each HPV type at day 1and month 7
Measured: Day 1 (baseline) and month 7
Seroconversion rate
The seroconversion rate by vaccination will be calculated.
Measured: Day 1 (baseline) and month 7
Secondary outcomes (2)
Titer of neutralizing antibody of each HPV type
The neutralizing antibodies titer between CKD stage IV-V and non-CKD subjects in case-match historical cohort will be analyzed.
Measured: Day 1 (bseline) and month 7
seroconversion rate
The conversion rate by vaccination between CKD stage IV-V and non-CKD subjects in case-match historical cohort will be analyzed.
Measured: day 1 (baseline) and month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease, Stage IV (Severe)Studies of the same condition, open and under way.
- More trials run by Chulalongkorn 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kearkiat Praditpornsilpa, Chulalongkorn University
- Investigators
- Kearkiat Praditpornsilpa, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298869
- Sponsor's protocol ID
- 2011/02_Medicine
- Status last verified
- Jan 2014
- First submitted
- 1 Feb 2011
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Immunogenicity of Quadrivalent Vaccine Against Human Papilloma Virus (HPV) Types 6, 11, 16, and 18 (HPV-6/11/16/18) in CKD Patients
- ClinicalTrials.gov ID
- NCT01298869
- Acronym / sponsor ID
- 2011/02_Medicine
- Keywords
- CKD, HPV infection, HPV vaccine, antibodies titer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical trials have demonstrated the efficacy of HPV-6/11/16/18 vaccination (Gardasil. Merck) 3 doses at day 1, month 2, and month 6 to lower the occurrence of high-grade cervical intraepithelial neoplasia than did those in the placebo group. The immunogenicity and efficacy of the HPV vaccine has not been proven in late stage chronic kidney disease (CKD) population. The cellular and humoral immune responsiveness of CKD population are impaired by the retention of uremic toxin due to glomerular filtration rate (GFR) reduction, the vaccination efficacy can be altered and the effective dose/schedule of the vaccine may need to be adjusted, mostly increase in CKD patients.
This study aims to investigate the immunogenicity of quadrivalent HPV-6/11/16/18 vaccination (Gardasil. Merck) by current recommended dose/schedule in CKD stage IV-V patients and compare to non-CKD patients. Although a minimal peak anti-HPV response associated with protective efficacy has not been determined, the equivalent immune response in CKD and non-CKD patients if can be demonstrated by this study should be extrapolated to the CKD population. If less immune response results, the more intense dose/schedule of the vaccine should be further studied.
Detailed description
Up to 70% of sexually active adults will become infected with human papillomavirus (HPV) during their lifetime. HPV infection can result in anogenital cancer and genital warts. These diseases are associated with substantial morbidity and mortality. Every year, 471,000 cases of cervical cancer are diagnosed worldwide. The 5-year survival for this disease is ~70%. The incidence of HPV-related anal cancer has doubled in the last 25 years. Screening programs to detect early disease are not available. Genital warts cause significant morbidity. Therefore, a prophylactic vaccine that reduces HPV infection will greatly reduce the burden of HPV disease. This study aims to demonstrate the immunogenicity of quadrivalent HPV-6/11/16/18 vaccination (Gardasil. Merck) by current recommended dose/schedule (day 1, and month 7) in CKD stage IV-V patients and to compare the immunogenicity of the vaccine in CKD stage IV-V patients and non-CKD subjects in historical cohort data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease | – | Biological: HPV-6/11/16/18 vaccineChronic kidney disease stage IV and V |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Chronic kidney disease stage IV and V population
Key inclusion criteria (6 listed)
- Subject is between the ages 18 - 26 years as of visit 1 and has GFR < 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease (MDRD) equation: eGFR = 175 x serum creatinine(-1.154) x Age(-0.203) x 0.742 (if female)
- Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory testing.
- Subject is able to understand study procedures and agrees to participate in the study by giving written informed consent.
- Subject is not pregnant now (as determined by a serum pregnancy test or urine pregnancy test sensitive to 25 IU -hCG) and agrees to use effective contraception through Month 7 of the study. Effective contraception will be considered: oral contraceptives, injection or implant contraception.
- Subject has had no temperature > 37.8 C (oral) within 24 hours prior to the first injection.
Key exclusion criteria (11 listed)
- Subject is pregnant.
- Subject has a history of known prior vaccination with an HPV vaccine.
- Subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
- Subject is allergic to any vaccine component, including aluminum, yeast, or BENZONASE.
- Subject has received any immune globulin or blood derived products within the 3 months prior to the first injection, or plans to receive any through Month 7 of the study.
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 |
|---|---|---|
| HPV-6/11/16/18 vaccineAlso: GardasilHPV-6/11/16/18 vaccination 3 doses at day 1, month 2, and month 6 | Biological | Chronic kidney disease |
Primary outcome
Titers of neutralizing antibodies for each HPV type
Time frame: Day 1 (baseline) and month 7
The geometric mean titers of neutralizing antibodies for each HPV type at day 1and month 7
Seroconversion rate
Time frame: Day 1 (baseline) and month 7
The seroconversion rate by vaccination will be calculated.
2 secondary outcomes
Titer of neutralizing antibody of each HPV type
Time frame: Day 1 (bseline) and month 7
seroconversion rate
Time frame: day 1 (baseline) and month 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
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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.
Kearkiat Praditpornsilpa, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, Stage IV (Severe) and Chronic Kidney Disease, Stage V, run by Chulalongkorn University at 1 site in Thailand.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titers of neutralizing antibodies for each HPV type (time frame: Day 1 (baseline) and month 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2014.