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

NCT01741012 | Completed Phase 1 Results DMC

• 1 other identifier: 0412GARDASIL
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Lupus

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• 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.

• SLE Disease Activity Flares

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

Study Arms (1)

Gardasil

EXPERIMENTAL

0.5 ml single dose Gardasil vaccine given at three separate visits

Drug: Gardasil

Interventions

Gardasil DRUG

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

Gardasil

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

DCaTS-Clinical Research Center

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• 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.

  PMID: 28404357 DERIVED

Related Links

• Clinical Research Services Center, Wayne State University School of Medicine

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Dr. J. Patricia Dhar, MD, Principal Investigator
• Organization: Wayne State University School of Medicine

pdhar@med.wayne.edu

313-577-6011

Study Officials

• Patricia J Dhar, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: December 4, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)