Systemic Lupus Erythematosus
Conditions
Keywords
Lupus
Brief summary
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.
Detailed description
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®.
Interventions
DRUGGardasil
0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6
Sponsors
Merck Sharp & Dohme LLC
Wayne State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Participants With Adverse Events | 1,61,66,181,186,211,330 days | Frequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events, |
| Number of Non Vaccine Adverse Events | 1,61,66,181,186,211,330 days | the number of non vaccine adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer | 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. | 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 |
| SLE Disease Activity Flares | 1,61,66,181,186,211,330 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Gardasil |
|---|---|
| Age, Continuous | 38.1 years STANDARD_DEVIATION 7.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 33 / 34 |
| serious Total, serious adverse events | 1 / 34 |
Outcome results
Primary
Frequency of Participants With Adverse Events
Frequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events,
Time frame: 1,61,66,181,186,211,330 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gardasil | Frequency of Participants With Adverse Events | vaccine site reactions | 21 Participants |
| Gardasil | Frequency of Participants With Adverse Events | non vaccine site reactions | 33 Participants |
Primary
Number of Non Vaccine Adverse Events
the number of non vaccine adverse events
Time frame: 1,61,66,181,186,211,330 days
Population: Number of non vaccine adverse events
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gardasil | Number of Non Vaccine Adverse Events | non vaccine adverse events | 493 events |
| Gardasil | Number of Non Vaccine Adverse Events | serious adverse events | 9 events |
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
Time frame: 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.
Population: The percentage of Human Papilloma Virus (HPV) naive women for HPV serotypes 6, 11, 16 and 18 that seroconverted
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gardasil | Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer | HPV 6 Serotype | 100 percentage of particpants |
| Gardasil | Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer | HPV 11 Serotype | 100 percentage of particpants |
| Gardasil | Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer | HPV 16 Serotype | 100 percentage of particpants |
| Gardasil | Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer | HPV 18 Serotype | 100 percentage of particpants |
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.
Time frame: 1,61,66,181,186,211,330 days
Population: Number of patients who had a lupus flare defined by a SELENA -SLEDAI \> or = to 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gardasil | SLE Disease Activity Flares | 0 Participants |