Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

Systemic Lupus Erythematosus Clinical Trial

Official title:

Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786409
• Other study ID #: 15960A
• Secondary ID: MERCK: MISP for
• Status: Completed
• Phase: N/A
• First received: November 5, 2008
• Last updated: February 14, 2018
• Start date: November 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2018
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.

Description:

Female patients with systemic lupus erythematosus (SLE) have been found have higher rates of persistent HPV infections and precancerous lesions compared to the healthy population. The HPV vaccine Gardasil has been found to be safe and efficacious in females aged 9 to 26 years. There are no data on the immunogenicity and safety of Gardasil in females with SLE. Immune dysfunction related to SLE itself and the immunosuppression secondary to treatment of SLE might prevent patients with SLE from developing an adequate immune response to the vaccine. Also, theoretically, the vaccine might induce a disease exacerbation or production of new autoantibodies.

The purpose of this study is to evaluate immunogenicity and safety of Gardasil and its effects on autoantibody profile in female SLE patients aged 9-26 years

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 9 Years to 26 Years

Eligibility

Inclusion Criteria:

• Age: 9 to 26 years of age

• Gender: Female

• All patients must fulfill the revised American College of Rheumatology Classification Criteria for SLE diagnosis.

• Current SLEDAI score = 6

• Written, witnessed informed consent and/or assent will be obtained from the subject and the subject's parents (if under 18 years of age) or legally acceptable representative prior to enrollment

Exclusion Criteria:

• Acute exacerbation of disease within past 30 days which required increase in corticosteroid dose, initiation of a new immunosuppressive medication, or hospitalization

• Current SLEDAI score > 6

• Patients who have received rituximab in the last 6 months, or are currently on cyclophosphamide treatment

• History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine

• Previous administration of any HPV vaccine

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• Gardasil
0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Nath R, Mant C, Luxton J, Hughes G, Raju KS, Shepherd P, Cason J. High risk of human papillomavirus type 16 infections and of development of cervical squamous intraepithelial lesions in systemic lupus erythematosus patients. Arthritis Rheum. 2007 May 15;57(4):619-25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HPV 6 Seroconversion	Percent Seropositive	7 months
Primary	Anti-HPV 6 GMT	Geometric mean titre in milli-Merck units per ml (mMu/ml)	7 months
Primary	Anti-HPV 11 Seroconversion	% Seropositive	7 months
Primary	Anti-HPV 11 GMT	Geometric mean titre in milli-Merck units per ml (mMu/ml)	7 months
Primary	Anti-HPV 16 Seroconversion	% Seropositive	7 months
Primary	Anti-HPV 16 GMT	Geometric mean titre in milli-Merck units per ml (mMu/ml)	7 months
Primary	Anti-HPV 18 Seroconversion	% Seropositive	7 months
Primary	Anti-HPV 18 GMT	Geometric mean titre in milli-Merck units per ml (mMu/ml)	7 months
Primary	SLEDAI Change Score	Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): change from baseline to 7 months. The SLEDAI scale is a weighted sum of 16 clinical and 8 laboratory items. Scores range from 0 to 105 with higher scores indicating worse outcome. The variable analyzed here is the 7 month score minus the baseline score. Therefore negative values indicate an improvement in outcome.	7 months
Secondary	Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP		7 months
Secondary	Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)		7 months
Secondary	Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)		7 months