Community Awareness, Resources and Education (CARE II): Project 3

Uterine Cervical Cancer Clinical Trial

Official title:

Community Awareness, Resources and Education (CARE II): Project 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299714
• Other study ID #: OSU-10096
• Secondary ID: P50CA105632OSU-1
• Status: Completed
• First received: February 15, 2011
• Last updated: April 23, 2018
• Start date: February 2011
• Est. completion date: April 2015

Study information

• Verified date: April 2018
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Researchers at The Ohio State University and the University of Michigan are working together to understand cancer of the cervix. One of the areas they are studying is how stress you may experience in your life effects the way you respond to GARDASIL®. GARDASIL® is a vaccine approved by the Food and Drug Administration (FDA) to prevent some types of Human Papillomavirus (HPV) infection which can cause cancer of the cervix. Participants are being recruited from the Appalachian region of Ohio.

Description:

A quadrivalent HPV 6, 11, 16, 18 vaccine (GARDASIL®) has been approved for use among women age 9-26 years to prevent cervical/vaginal/vulvar cancer and genital warts. The efficacy of the vaccine has been demonstrated in clinical trial settings, but the effectiveness of this vaccine has not been tested in clinical practice settings. Patients experiencing greater stress have a reduced capacity to mount an immune response to other types of vaccine. The same phenomenon is likely to exist for Gardasil, but there are no data. The impact of psychological stress on the immune response to a vaccine is proposed to act via health behaviors (multiple lifetime sexual partners, never using condoms, prior abnormal Pap smear, smoking, and HPV infection) or by direct dysregulation of the immune system. We have found higher rates of cervical HPV in Appalachian Ohio women, higher rates of abnormal cervical cytology, and very high rates of psychological stress compared to urban and suburban women. The goal of this study is to determine if, in women age 18-26 years given GARDASIL® vaccine, serum HPV 6/11/16/18 antibody response is altered by stress. This will be accomplished by a study of 432 women age 18-26 years who report full range of life stressors recruited from Appalachian Ohio. All participants will receive the GARDASIL® vaccine at baseline, two months, and six months. Prior to vaccination questionnaire data related to HPV exposure risk behaviors and psychological stressors will be collected. Cervical samples will be collected for cytology and HPV testing. Serum samples will be collected for HPV 6, 11, 16 and 18 antibody assays at baseline and month 12. The questionnaire data and serum samples will be repeated at 12 months. The primary outcome measure is the difference in serum antibodies to HPV 6, 11, 16 and 18 at baseline and month 12. The variables of interest are perceived stress, sexual behaviors, socioeconomic status, access to health care (health insurance yes/no), smoking, Appalachian self-identity, HPV cervical status at baseline, and past history abnormal cervical cytology, as proposed in a psychoneuroimmunology model. In this model, Appalachian Self-Identity, socioeconomic status, loneliness, health care access, and coping are proposed to contribute to a woman's perceived stress. The impact of perceived stress on immune response to Gardasil vaccination can be by health behaviors such as multiple lifetime sexual partners (>4), never using condoms, prior abnormal Pap smear, smoking, and HPV status at the time of vaccination. Perceived stress can have a direct physiologic impact on the immune response by creating immune dysregulation as measured by increased EBV VCA-IgG titers. Depressive symptoms can mediate the impact of perceived stress on immune function. If psychological stress is found to modulate the immune response to GARDASIL®, then we can determine if the modulation reduces the clinical effectiveness of the vaccine and examine methods to limit the impact of stress.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: April 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

• Female

• 18-26 years of age

• Resident of an Appalachian county

• Intact cervix

• Able to read and understand English

• Cognitively able to provide informed consent

• Willing to come for four clinic visits

Exclusion Criteria:

• Prior history of cervical cancer

• Prior history of a cervical lesion treated with cryotherapy or any form of surgical removal of a portion of the cervix to treat CIN

• No cervix

• Pregnant or planning to become pregnant in the next year

• History of immune disorder: auto-immune, primary immune or acquired

• Any contra-indications for the GARDASIL® vaccine series

• Taking immune suppressive medications

• Any prior exposure to an HPV vaccine of any type

• Planning to move out of the immediate area in the next year

Related Conditions & MeSH terms

• Uterine Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	Merck Sharp & Dohme Corp., National Cancer Institute (NCI), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum antibody levels for HPV 6,11,16 and 18		12 months
Secondary	serum antibody levels for Epstein-Barr Virus (EBV)		baseline
Secondary	Center for Epidemiological Studies - Depression (CES-D) Scale Score		12 months
Secondary	perceived stress		12-months

External Links

•   CARE: Project 3 Study