Status:
COMPLETED
Immune Memory After Papillomavirus Vaccination
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Healthy Volunteers
Eligibility:
FEMALE
18-30 years
Brief Summary
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 t...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Female ages 18-26 inclusive (18-30 for women who have been previously vaccinated
- 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.
- Able to give informed consent
- Negative urine pregnancy test at enrollment
Exclusion
- Currently pregnant, breast feeding or planning a pregnancy
- Underlying immunological disease, such as previously diagnosed HIV infection or history of transplantation, history of splenectomy
- Use of medications with potential immunological effects such as systemic corticosteroids or chemotherapy
- Prior therapy for cervical dysplasia or cervical cancer such as loop excision, laser ablation, cryotherapy or hysterectomy
- Unable to comply with protocol
- Severe allergic reaction (e.g., anaphylaxis) after a previous vaccine dose or to a vaccine component
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT01505049
Start Date
January 1 2012
End Date
January 1 2015
Last Update
July 21 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory University
Atlanta, Georgia, United States, 30322