Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

Clinical Trials.gov

This study is not yet open for participant recruitment.
Verified by University of Chicago, November 2008
First Received: November 5, 2008   No Changes Posted
Sponsor: University of Chicago
Collaborator: Merck
Information provided by: University of Chicago
ClinicalTrials.gov Identifier: NCT00786409
Purpose

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

Study Type: Interventional
Study Design: Control: Historical Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26

Resource links provided by NLM:

MedlinePlus related topics: Lupus
Further study details as provided by University of Chicago:

Primary Outcome Measures:

  • Primary outcome measures are Mean Geometric HPV Antibody Titers and a change in SLE disease activity [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

  • Secondary outcome measure is induction or increase of autoantibodies [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Gardasil

30 patients will receive 0.5 ml Gardasil vaccine at months 0,2, and 6.
Biological: Gardasil

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

Detailed 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.

MORE…

a) Too little too late?

b) The cart before – the horse?

c) Pressure from the public?

The answer is “c.”  Women with autoimmune diseases were not tested for adverse reactions to the HPV vaccines.

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.