Immune Memory After Papillomavirus Vaccination

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Vaccines

Criteria

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