View Clinical Trial (Medical Research Study)
Immune Memory After Papillomavirus Vaccination
| City: |
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Atlanta |
| State: |
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Georgia |
| Zip Code: |
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30322 |
| Conditions: |
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Healthy Volunteers |
| Purpose: |
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Vaccines for human papillomavirus (HPV) have been available in the United States since 2006.
Early studies have shown a high rate of effectiveness of these vaccines, however it is not
known how long this protection will last. The IMAP study will look at various parts of the
immune system and potential markers for long lived immune responses to this vaccine.
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| Study Summary: |
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Three groups of patients will be recruited for this study. One group will be women who
have completed all three vaccinations. The second group will be women who are overdue for
their final vaccination. We also recruit women who have not been vaccinated previously.
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| Criteria: |
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Inclusion Criteria:
1. Female ages 18-26 inclusive (18-30 for women who have been previously vaccinated
2. If sexually active and enrolled in unvaccinated group, must use a reliable form of
birth control for the first seven months of the study. For the purposes of this
protocol a reliable form will be hormonal or barrier contraception. Intrauterine
devices and a history of sterilization will also be considered reliable forms of
birth control. Abstaining from sex is also a reliable form of contraception.
3. Able to give informed consent
4. Negative urine pregnancy test at enrollment
Exclusion Criteria:
1. Currently pregnant, breast feeding or planning a pregnancy
2. Underlying immunological disease, such as previously diagnosed HIV infection or
history of transplantation, history of splenectomy
3. Use of medications with potential immunological effects such as systemic
corticosteroids or chemotherapy
4. Prior therapy for cervical dysplasia or cervical cancer such as loop excision, laser
ablation, cryotherapy or hysterectomy
5. Unable to comply with protocol
6. Severe allergic reaction (e.g., anaphylaxis) after a previous vaccine dose or to a
vaccine component
7. An acute illness, including an oral temperature of 100.4 degrees F within three days
of visit
other more specific exclusions may apply to one of the three cohorts
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| NCT ID: |
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NCT01505049 |
| Primary Contact: |
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Principal Investigator
Kevin A Ault, MD
Emory University
Kevin A Ault, MD
Phone: 404-251-8809
Email: kevin.ault@emory.edu
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| Backup Contact: |
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Email: kbarrett@emory.edu
Kara Barrett, RN
Phone: 404-712-9367
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| Location Contact: |
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Atlanta, Georgia 30322
United States
Kara Barrett, RN
Phone: 404-712-9367
Email: kbarret@emory.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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