Back to results

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

Primary Purpose

Systemic Lupus Erythematosus

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Gardasil

About this trial

This is an interventional prevention trial for Systemic Lupus Erythematosus focused on measuring Lupus

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

DCaTS-Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gardasil

Arm Description

0.5 ml single dose Gardasil vaccine given at three separate visits

Outcomes

Primary Outcome Measures

Frequency of Participants With Adverse Events

Frequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events,

Number of Non Vaccine Adverse Events

the number of non vaccine adverse events

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT01741012

First Posted

November 14, 2012

Last Updated

February 26, 2018

Sponsor

Wayne State University

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01741012

Brief Title

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

Acronym

GARDASIL

Official Title

Phase I, Safety and Immunogenicity of Gardasil® in Systemic Lupus Erythematosus.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wayne State University

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

Lupus

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gardasil

Arm Type

Experimental

Arm Description

0.5 ml single dose Gardasil vaccine given at three separate visits

Intervention Type

Drug

Intervention Name(s)

Gardasil

Intervention Description

0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6

Primary Outcome Measure Information:

Title

Frequency of Participants With Adverse Events

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

Title

Number of Non Vaccine Adverse Events

Description

the number of non vaccine adverse events

Time Frame

1,61,66,181,186,211,330 days

Secondary Outcome Measure Information:

Title

Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer

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.

Title

SLE Disease Activity Flares

Description

Time Frame

1,61,66,181,186,211,330 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patricia J Dhar, MD

Organizational Affiliation

Wayne State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

DCaTS-Clinical Research Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No individual data will be shared with any researcher, only aggregated de-identified data

Citations:

PubMed Identifier

28404357

Citation

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.

Results Reference

derived

Links:

URL

http://clinicalresearch.med.wayne.edu/oncore.php

Description

Clinical Research Services Center, Wayne State University School of Medicine

Learn more about this trial

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

We'll reach out to this number within 24 hrs