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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Cervical neoplasia is increased in women with SLE most likely due to cervical infection with human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18. Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies have been done on the use of this vaccine in SLE. The investigators hypothesize that Gardasil vaccine is safe and effective in SLE. This study will look at vaccine safety in patients with mild to moderate and minimally active or inactive SLE and measure how well they make protective antibodies after receiving the vaccine. In other words this will check how well the vaccine works in SLE.
To gather safety information and adverse events on the use of Gardasil® in mild to moderate and minimally active or inactive SLE.
To gather information on SLE disease activity flares after vaccination with Gardasil®.
To gather information on the immunogenicity or development of protective anti HPV antibodies SLE after vaccination with Gardasil®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gardasil | Experimental | 0.5 ml single dose Gardasil vaccine given at three separate visits |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gardasil | Drug | 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Participants With Adverse Events | Frequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events, | 1,61,66,181,186,211,330 days |
| Number of Non Vaccine Adverse Events | the number of non vaccine adverse events | 1,61,66,181,186,211,330 days |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer | 1. The percentage of HPV naive women who seroconverted by HPV serotypes was measured using Geometric Mean Titers for HPV serotypes HPV 6, HPV 11, HPV 16, HPV 18 | Baseline (prevaccine) neutralizing anti HPV antibody titers at visit 1 and anti HPV antibody titers at 1 month post 3rd vaccine shot which is at 7 months in the study. |
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Inclusion Criteria:
Diagnosis of systemic lupus erythematosis (SLE) by the American College of Rheumatology (ACR) Criteria.
History of a positive antinuclear antibody (ANA) test result at any time in the past.
40 participants with history of mild to moderate SLE disease Minimally active or inactive SLE disease, i.e., (Safety of Estrogens in Lupus Erythematosis National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), SELENA-SLEDAI ≤2 at the start of the study.
Age ≥ 18 years and ≤ 50 years. Gender: females Ability to provide informed consent. Maintenance Prednisone dose ≤ 15 mg/day. Plaquenil ≤ 400 mg/day.
Exclusion Criteria:
Hypersensitivity to any vaccine component Active infections including but not limited to human immunodeficiency virus (HIV positive), Hepatitis B or C, tuberculosis.
Positive purified protein derivative (PPD) test results without evidence of prior treatment or administration of bacilli Calmette-Guerin (BCG) vaccine. A positive PPD is defined as ≥ 5 mm induration 24-38 hours after receiving 5TU (TU=tuberculin units) of PPD.
Pregnancy or desire to become pregnant during the study period. Breast feeding. Inability to complete the immunization series. Received any blood product or component in the previous 6 months before enrollment.
Received any inactivated vaccine product within 14 days before enrollment. Received any live vaccine product within 21 days before enrollment.
Fever (temperature > 100°F) at the time of enrollment. Inability to provided informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Patricia J Dhar, MD | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DCaTS-Clinical Research Center | Detroit | Michigan | 48201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28404357 | Derived | Dhar JP, Essenmacher L, Dhar R, Magee A, Ager J, Sokol RJ. The safety and immunogenicity of Quadrivalent HPV (qHPV) vaccine in systemic lupus erythematosus. Vaccine. 2017 May 9;35(20):2642-2646. doi: 10.1016/j.vaccine.2017.04.001. Epub 2017 Apr 9. |
| Label | URL |
|---|---|
| Clinical Research Services Center, Wayne State University School of Medicine | View source |
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No individual data will be shared with any researcher, only aggregated de-identified data
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| ID | Title | Description |
|---|---|---|
| FG000 | Gardasil | Single treatment arm: 0.5 ml single dose Gardasil vaccine given at three separate visits Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gardasil | Single treatment arm: 0.5 ml single dose Gardasil vaccine given at three separate visits Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Participants With Adverse Events | Frequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events, | Posted | Count of Participants | Participants | 1,61,66,181,186,211,330 days |
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Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gardasil | Single treatment arm: 0.5 ml single dose Gardasil vaccine given at three separate visits Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain and arm pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Chest pain and arm pain due to atypical non cardiac chest pain and a pinched nerve affecting the arm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| musculoskeletal | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | There were 106 number of musculoskeletal non vaccine related adverse events in 34 patients |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. J. Patricia Dhar, MD, Principal Investigator | Wayne State University School of Medicine | 313-577-6011 | pdhar@med.wayne.edu |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| SLE Disease Activity Flares | SELENA-SLEDAI measurements > or = to 2 The SELENA/SLEDAI is a validated instrument which is used to score disease activity and define flares with the SELENA-SLEDAI score range being 0-105, with 0 indicating inactive disease.The SELENA/SLEDAI instrument consists of 24 items, each with a definition of activity; there are 16 clinical items and 8 laboratory items. Although there are no set standards, inactive or minimal disease is generally reflected by a SELENA/SLEDAI score of less than or equal to 2 while more than minimally active disease is reflected by a score of >2. | 1,61,66,181,186,211,330 days |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Non Vaccine Adverse Events | the number of non vaccine adverse events | Number of non vaccine adverse events | Posted | Number | events | 1,61,66,181,186,211,330 days |
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| Secondary | Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer | 1. The percentage of HPV naive women who seroconverted by HPV serotypes was measured using Geometric Mean Titers for HPV serotypes HPV 6, HPV 11, HPV 16, HPV 18 | The percentage of Human Papilloma Virus (HPV) naive women for HPV serotypes 6, 11, 16 and 18 that seroconverted | Posted | Number | percentage of particpants | Baseline (prevaccine) neutralizing anti HPV antibody titers at visit 1 and anti HPV antibody titers at 1 month post 3rd vaccine shot which is at 7 months in the study. |
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| Secondary | SLE Disease Activity Flares | SELENA-SLEDAI measurements > or = to 2 The SELENA/SLEDAI is a validated instrument which is used to score disease activity and define flares with the SELENA-SLEDAI score range being 0-105, with 0 indicating inactive disease.The SELENA/SLEDAI instrument consists of 24 items, each with a definition of activity; there are 16 clinical items and 8 laboratory items. Although there are no set standards, inactive or minimal disease is generally reflected by a SELENA/SLEDAI score of less than or equal to 2 while more than minimally active disease is reflected by a score of >2. | Number of patients who had a lupus flare defined by a SELENA -SLEDAI > or = to 2 | Posted | Count of Participants | Participants | 1,61,66,181,186,211,330 days |
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| 0 |
| 34 |
| 1 |
| 34 |
| 33 |
| 34 |
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| unplanned pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment | Unplanned pregnancy. Patient chose to terminate the pregnancy |
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| nausea and vomiting with hypertensive crisis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Nausea and vomiting due to gastritis with dehydration Hypertensive crisis due to non compliance with hypertension medications |
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| unplanned pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment | unplanned pregnancy. Patient chose voluntary termination of pregnancy |
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| Chest pain and shortness of breath with left sided numbness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Non cardiac chest pain due to fibromyalgia. Cardiac disease ruled out. |
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| pain, swelling and discharge of the right breast | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment | Pain, swelling and discharge of the right breast due to a blocked duct |
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| shortness of breath and itching after eating peanut butter | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment | Allergic reaction to peanut butter.Pt had known allergy to peanuts |
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| chest pain non cardiogenic | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Chest pain radiating down left arm due to DJD (degenerative joint disease) of the Cervical spine with radiculopathy Cardiac work up negative |
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| swollen left leg with ulcer | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Edema with superficial laceration which healed |
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| nervouus system | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | There were 102 Nervous system non vaccine related adverse events in 34 patients |
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| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | There were 49 gastrointestinal non vaccine related adverse events in 18 patients |
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| General disorders | General disorders | MedDRA (Unspecified) | Systematic Assessment | There were 45 general disorder non vaccine related adverse events in 17 patients |
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| dermatologic | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | There were 45 dermatologic non vaccine related adverse events in 17 |
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| infections | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | There were 44 non vaccine related infectious adverse events in 21 patients |
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| respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | There were 29 respiratory non vaccine related adverse events in 12 patients |
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| vascular disorder | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment | There were 18 vascular disorder non vaccine related adverse events in 10 patients |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | There were 8 metabolism and nutrition non vaccine related adverse events in 7 patients |
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| renal and urinary disorders | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | There were 6 renal and urinary disorder non vaccine related adverse events in 6 people |
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| reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment | There were 7 reproductive and breast non vaccine related adverse events in 6 patients |
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| psychiatric disorders | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment | There were 12 psychiatric disorder non vaccine related adverse events in 5 patients |
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| immune system disorders | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment | There were 4 immune system disorder non vaccine related adverse events in 4 patients |
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| Blood and Lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment | There were 3 blood and lymphatic disorder non vaccine related adverse events in 3 patients |
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| Ear and labyrinth disorders | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment | There were 4 ear and labyrinth disorder non vaccine related adverse events in 3 patients |
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| Eye disorders | Eye disorders | MedDRA (Unspecified) | Systematic Assessment | There were 3 eye disorder non vaccine related adverse events in 3 patients |
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| injury poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | There were 3 injury, poisoning and procedural complications in 3 patients |
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| Surgical and medical procedures | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment | There were 5 surgical and medical procedure non vaccine related adverse events in 3 patients |
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| Cardiac disorders | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | There were 2 cardiac disorder non vaccine related adverse events in 2 patients |
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| neoplasms benign, malignant and unspecified (incl dysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment | There were 2 neoplasms benign, malignant, and unspecified non vaccine related adverse events in 2 patients |
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| Pregnancy , puerperium and perinatal conditions | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment | There were 2 pregnancy, puerperium and perinatal condition non vaccine related adverse events in 2 patients |
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| Hepatobiliary disorders-other | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment | There was one hepatobiliary disorder non vaccine related adverse event in one patient |
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| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
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| HPV 16 Serotype |
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| HPV 18 Serotype |
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