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Trial record 19 of 698 for:    lupus

Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients (GARDASIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01741012
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Patricia Dhar, Wayne State University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Systemic Lupus Erythematosus
Intervention Drug: Gardasil
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gardasil
Hide Arm/Group Description

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

Period Title: Overall Study
Started 37
Completed 34
Not Completed 3
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             2
Arm/Group Title Gardasil
Hide Arm/Group Description

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

Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants
38.1  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
34
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
27
  79.4%
White
6
  17.6%
More than one race
1
   2.9%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
1.Primary Outcome
Title Frequency of Participants With Adverse Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gardasil
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
vaccine site reactions
21
  61.8%
non vaccine site reactions
33
  97.1%
2.Primary Outcome
Title Number of Non Vaccine Adverse Events
Hide Description the number of non vaccine adverse events
Time Frame 1,61,66,181,186,211,330 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non vaccine adverse events
Arm/Group Title Gardasil
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: events
non vaccine adverse events 493
serious adverse events 9
3.Secondary Outcome
Title Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
The percentage of Human Papilloma Virus (HPV) naive women for HPV serotypes 6, 11, 16 and 18 that seroconverted
Arm/Group Title HPV Serotype Naive Women
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: percentage of particpants
HPV 6 Serotype Number Analyzed 16 participants
100
HPV 11 Serotype Number Analyzed 27 participants
100
HPV 16 Serotype Number Analyzed 19 participants
100
HPV 18 Serotype Number Analyzed 27 participants
100
4.Secondary Outcome
Title SLE Disease Activity Flares
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients who had a lupus flare defined by a SELENA -SLEDAI > or = to 2
Arm/Group Title Gardasil
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Data was collected for 18 months for each patient over the trial study period
Adverse Event Reporting Description

Adverse events (AEs) were collected by:

  1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet
  2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination
  3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls.
  4. weekly phone calls
  5. once per month scripted phone calls
 
Arm/Group Title Gardasil
Hide Arm/Group Description

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

All-Cause Mortality
Gardasil
Affected / at Risk (%)
Total   0/34 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Gardasil
Affected / at Risk (%) # Events
Total   1/34 (2.94%)    
Gastrointestinal disorders   
nausea and vomiting with hypertensive crisis  1 [1]  1/34 (2.94%)  1
Immune system disorders   
shortness of breath and itching after eating peanut butter  1 [2]  1/34 (2.94%)  1
Musculoskeletal and connective tissue disorders   
Chest pain and arm pain  1 [3]  1/34 (2.94%)  1
Chest pain and shortness of breath with left sided numbness  1 [4]  1/34 (2.94%)  1
chest pain non cardiogenic  1 [5]  1/34 (2.94%)  1
swollen left leg with ulcer  1 [6]  1/34 (2.94%)  1
Pregnancy, puerperium and perinatal conditions   
unplanned pregnancy  1 [7]  1/34 (2.94%)  1
unplanned pregnancy  1 [8]  1/34 (2.94%)  1
Reproductive system and breast disorders   
pain, swelling and discharge of the right breast  1 [9]  1/34 (2.94%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
[1]
Nausea and vomiting due to gastritis with dehydration Hypertensive crisis due to non compliance with hypertension medications
[2]
Allergic reaction to peanut butter.Pt had known allergy to peanuts
[3]
Chest pain and arm pain due to atypical non cardiac chest pain and a pinched nerve affecting the arm
[4]
Non cardiac chest pain due to fibromyalgia. Cardiac disease ruled out.
[5]
Chest pain radiating down left arm due to DJD (degenerative joint disease) of the Cervical spine with radiculopathy Cardiac work up negative
[6]
Edema with superficial laceration which healed
[7]
Unplanned pregnancy. Patient chose to terminate the pregnancy
[8]
unplanned pregnancy. Patient chose voluntary termination of pregnancy
[9]
Pain, swelling and discharge of the right breast due to a blocked duct
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gardasil
Affected / at Risk (%) # Events
Total   33/34 (97.06%)    
Blood and lymphatic system disorders   
Blood and Lymphatic system disorders  1 [1]  3/34 (8.82%)  3
Cardiac disorders   
Cardiac disorders  1 [2]  2/34 (5.88%)  2
Ear and labyrinth disorders   
Ear and labyrinth disorders  1 [3]  3/34 (8.82%)  4
Eye disorders   
Eye disorders  1 [4]  3/34 (8.82%)  3
Gastrointestinal disorders   
Gastrointestinal disorders  1 [5]  18/34 (52.94%)  49
General disorders   
General disorders  1 [6]  17/34 (50.00%)  45
Hepatobiliary disorders   
Hepatobiliary disorders-other  1 [7]  1/34 (2.94%)  1
Immune system disorders   
immune system disorders  1 [8]  4/34 (11.76%)  4
Infections and infestations   
infections  1 [9]  21/34 (61.76%)  44
Injury, poisoning and procedural complications   
injury poisoning and procedural complications  1 [10]  3/34 (8.82%)  3
Metabolism and nutrition disorders   
Metabolism and nutrition disorders  1 [11]  7/34 (20.59%)  8
Musculoskeletal and connective tissue disorders   
musculoskeletal  1 [12]  24/34 (70.59%)  106
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
neoplasms benign, malignant and unspecified (incl dysts and polyps)  1 [13]  2/34 (5.88%)  2
Nervous system disorders   
nervouus system  1 [14]  25/34 (73.53%)  106
Pregnancy, puerperium and perinatal conditions   
Pregnancy , puerperium and perinatal conditions  1 [15]  2/34 (5.88%)  2
Psychiatric disorders   
psychiatric disorders  1 [16]  5/34 (14.71%)  12
Renal and urinary disorders   
renal and urinary disorders  1 [17]  6/34 (17.65%)  6
Reproductive system and breast disorders   
reproductive system and breast disorders  1 [18]  6/34 (17.65%)  7
Respiratory, thoracic and mediastinal disorders   
respiratory disorder  1 [19]  12/34 (35.29%)  29
Skin and subcutaneous tissue disorders   
dermatologic  1 [20]  17/34 (50.00%)  45
Surgical and medical procedures   
Surgical and medical procedures  1 [21]  3/34 (8.82%)  5
Vascular disorders   
vascular disorder  1 [22]  10/34 (29.41%)  18
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
[1]
There were 3 blood and lymphatic disorder non vaccine related adverse events in 3 patients
[2]
There were 2 cardiac disorder non vaccine related adverse events in 2 patients
[3]
There were 4 ear and labyrinth disorder non vaccine related adverse events in 3 patients
[4]
There were 3 eye disorder non vaccine related adverse events in 3 patients
[5]
There were 49 gastrointestinal non vaccine related adverse events in 18 patients
[6]
There were 45 general disorder non vaccine related adverse events in 17 patients
[7]
There was one hepatobiliary disorder non vaccine related adverse event in one patient
[8]
There were 4 immune system disorder non vaccine related adverse events in 4 patients
[9]
There were 44 non vaccine related infectious adverse events in 21 patients
[10]
There were 3 injury, poisoning and procedural complications in 3 patients
[11]
There were 8 metabolism and nutrition non vaccine related adverse events in 7 patients
[12]
There were 106 number of musculoskeletal non vaccine related adverse events in 34 patients
[13]
There were 2 neoplasms benign, malignant, and unspecified non vaccine related adverse events in 2 patients
[14]
There were 102 Nervous system non vaccine related adverse events in 34 patients
[15]
There were 2 pregnancy, puerperium and perinatal condition non vaccine related adverse events in 2 patients
[16]
There were 12 psychiatric disorder non vaccine related adverse events in 5 patients
[17]
There were 6 renal and urinary disorder non vaccine related adverse events in 6 people
[18]
There were 7 reproductive and breast non vaccine related adverse events in 6 patients
[19]
There were 29 respiratory non vaccine related adverse events in 12 patients
[20]
There were 45 dermatologic non vaccine related adverse events in 17
[21]
There were 5 surgical and medical procedure non vaccine related adverse events in 3 patients
[22]
There were 18 vascular disorder non vaccine related adverse events in 10 patients
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. J. Patricia Dhar, MD, Principal Investigator
Organization: Wayne State University School of Medicine
Phone: 313-577-6011
Responsible Party: Patricia Dhar, Wayne State University
ClinicalTrials.gov Identifier: NCT01741012     History of Changes
Other Study ID Numbers: 0412GARDASIL
First Submitted: November 14, 2012
First Posted: December 4, 2012
Results First Submitted: March 23, 2017
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018