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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01299714
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : April 25, 2018
National Cancer Institute (NCI)
University of Michigan
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Electra Paskett, Ohio State University

Brief 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.

Condition or disease
Uterine Cervical Cancer

Detailed 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.

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Study Type : Observational
Actual Enrollment : 191 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Community Awareness, Resources and Education (CARE II): Project 3
Study Start Date : February 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : April 2015

Primary Outcome Measures :
  1. serum antibody levels for HPV 6,11,16 and 18 [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. serum antibody levels for Epstein-Barr Virus (EBV) [ Time Frame: baseline ]
  2. Center for Epidemiological Studies - Depression (CES-D) Scale Score [ Time Frame: 12 months ]
  3. perceived stress [ Time Frame: 12-months ]

Biospecimen Retention:   Samples With DNA
serum, Pap specimen, cervical specimen for HPV analysis, oral rinse specimen, saliva specimen

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be female, aged 18 - 26 years, residing in an Appalachian region, with no history of HPV vaccination.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01299714

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United States, Ohio
Athens, Ohio, United States, 45701
Gallipolis, Ohio, United States, 45631
Logan, Ohio, United States, 43138
Pomeroy, Ohio, United States, 45769
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
University of Michigan
Merck Sharp & Dohme Corp.
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Principal Investigator: Mack T Ruffin, IV, MD, MPH University of Michigan
Study Director: Electra D Paskett, PhD Ohio State University

Additional Information:
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Responsible Party: Electra Paskett, Marion N. Rowley Professor of Cancer Research and Director-Division of Cancer Prevention and Control, Ohio State University Identifier: NCT01299714     History of Changes
Other Study ID Numbers: OSU-10096
P50CA105632 ( U.S. NIH Grant/Contract )
OSU-10096 ( Other Identifier: OSU Comprehensive Cancer Center )
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Keywords provided by Electra Paskett, Ohio State University:
Human Papilloma Virus
cervical cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female