Immune Memory After Papillomavirus Vaccination

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Immune Memory After Papillomavirus Vaccination (IMAP-I) Study . DMID 10-0014

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: quadrivalent HPV vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previously received all three doses of HPV vaccine<br>This group will consist of 78 women ages 18 to 30 who have received their third dose of vaccine three or more years ago. Recruitment of this group was completed in Sept 2012. | |
| Previously received two doses of HPV vaccine<br>This group will consist of 78 women ages 18 to 30 who have received two doses of the HPV vaccine. The second dose must have been received six or more months ago. | Drug: quadrivalent HPV vaccine<br>* For the group who have received two prior doses of vaccine, the third and final dose of vaccine will be given. For the unvaccinated cohort, women will receive all three doses of the vaccine. The second dose of the vaccine will be given two months after the first dose. The third and final dose of the vaccine will be given six months after the first dose.<br>* Other names: Gardasil if the trade name of the quadrivalent HPV vaccine.;|
| Unvaccinated Cohort<br>This group will consist of 45 women who have not received their HPV vaccination. Women ages 18-26 are eligible for this cohort. Recruitment for this group was completed in January 2013. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine markers of immune memory in women receiving quadrivalent HPV vaccine including antibody levels and memory B cells |  | 2 years after first vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunology, vaccination, human papillomavirus