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| ID | Type | Description | Link |
|---|---|---|---|
| DMID 10-0014 | Other Identifier | Other |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously received all three doses of HPV vaccine | 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 | 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. |
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| Unvaccinated Cohort | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quadrivalent HPV vaccine | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
other more specific exclusions may apply to one of the three cohorts
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we are seeking healthy female volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Mulligan, MD | Emory University | Principal Investigator |
| Kevin Ault, MD | University of Kansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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we will retain lymphocyte samples for testing immune function
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| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |